Category: Life Sciences Industry

Navigating the Generative AI Conundrum in Life Sciences: Insights into Challenges, Implications, and an Adoption Roadmap for Commercial Technology Functions  

The life sciences industry can reap the many benefits of Generative Artificial Intelligence (GAI) by effectively overcoming challenges in this highly regulated industry to responsibly implement the technology. Discover key implications for technology players and a roadmap for enterprises to successfully adopt GAI for commercial functions.  

Help us learn more about the potential of gen AI in the life sciences commercial function by participating in this short survey and receive a complimentary summary of the survey findings.

In the first blog in this series, we explored Gen AI life sciences commercial use cases, shared industry leaders’ skeptical to optimistic perspectives on its potential, and uncovered new technology offerings. Read on for more insights into key risks, repercussions, and recommendations to adopt generative AI in life sciences.

“With great power comes great responsibility.” – Uncle Ben, Spiderman

Undoubtedly, Gen AI has massive potential to disrupt most processes and create new opportunities across industries, including the life sciences commercial function. But the highly regulated nature of this industry brings significant risks and challenges that will need to be overcome to adopt GAI at scale. Let’s explore this further in the illustration below:

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Risks and challenges associated with generative AI in life sciences

Key implications for the life sciences commercial technology ecosystem

“A journey of a thousand miles begins with a single step.” – Lao Tzu

While the Gen AI journey can appear long and daunting, commercial technology players may have a head start over their peers across the life sciences value chain. While certain use cases, such as personalized campaign generation and brand reputation monitoring, will require complex integrations and domain-specific development, other applications like content generation/analytics, market research, and autonomous customer support can be quickly implemented and brought to market.

Next, let’s take a look at six recommendations for life sciences technology providers to seize opportunities that GAI presents.

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Key Implications for life sciences commercial technology players
  1. Take a safety-first approach: First and foremost, commercial technology players need to address the safety aspects of Gen AI adoption and applications – from healthcare personnel/patient data safety and security to compliance with regulations and tackling ethical and legal risks. Providers that successfully address safety questions will instill trust and reliability with customers and gain a foot in the door to discuss and foster responsible Gen AI application across the commercial function
  1. Seize the opportunity to achieve domain specificity at scale: By combining the domain-data trained language models and large language models (LLMs), Gen AI provides a great opportunity for commercial technology players to offer domain specificity at scale across a wider range of solutions and areas. This integration enables the generation of more accurate, relevant, and specific outputs in the life sciences commercial function context, ensuring quicker model training, fine-tuning of responses, and domain-specific prompting
  1. Recognize that speed-to-market is essential: Technology providers must quickly identify, prioritize, and bring viable go-to-market opportunities and use cases to capture market attention, and, ultimately, the enterprise mindshare. While enterprises are still determining next steps with Gen AI, they are eager to learn more, explore potential use cases, and become better educated. Therefore, the velocity of go-to-market initiatives is immensely valuable
  1. Balance incremental and disruptive innovations: To succeed in the market, players will need to balance their bets between simpler quick-to-market propositions that augment existing capabilities and more strategic long-term opportunities that explore new segments, functionality, etc. With the abundance of possibilities, providers should carefully weigh options
  1. Partner with service providers: Service providers can be important allies in ensuring enterprise-wide acceptance and adoption of AI-enabled services. Technology players should look to forge strategic ties with service providers who need to be the flag bearers for technology modernization, data architecture, and process and change management initiatives
  1. Prepare to win the talent war: As demand for new skills (such as generative modeling, data engineering, and ethical AI) rises, the talent war is expected to get more vigorous. Players must proactively plan for strategic hiring and upskilling/cross-skilling initiatives

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Enterprises are still evaluating the Gen AI conundrum across the entire life sciences commercial function, including the risks, challenges, costs, return on investment (RoI), talent, and processes. Our five-step GAI tools adoption guide can help enterprises accelerate this process, as illustrated below:

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While Gen AI holds immense promise for transforming the life sciences commercial landscape, it comes with its fair share of challenges, including ethical considerations, data quality, interpretability, and integration hurdles that need to be addressed to ensure responsible and successful adoption.

Technology providers can proactively develop strategies and solutions to overcome these obstacles. By crafting a thoughtful roadmap, committing to ethical practices, and focusing on continuous learning and improvement, the life sciences commercial solutions supply ecosystem can harness the power of Gen AI to unlock new opportunities, enhance customer experiences, and drive sustainable industry growth. While the journey to adopt Gen AI may be complex, the rewards for successful navigation are boundless.

Help us as we research the possibilities of Gen AI in the life sciences commercial sector by taking part in this brief survey. As a token of appreciation, you will receive a complimentary summary of the survey results.

To discuss Gen AI in life sciences and its impact on the commercial technology landscape, contact Rohit K, Durga Ambati, Panini K.

Exploring the Potential of Generative AI in the Life Sciences Commercial Technology Landscape | Blog

As the life sciences industry shifts from a traditional model to a hybrid commercial model, Generative Artificial Intelligence (GAI) can potentially be a valuable tool for commercial functions ranging from customer support to lead generation. Read on to learn about the investments providers are making in GAI and leaders’ viewpoints when it comes to embracing this technology.     

Watch the webinar, Welcoming the AI Summer: How Generative AI is Transforming Experiences, to learn more about how enterprises can leverage GAI to unlock business value.

Introduction of Generative AI in the life sciences commercial function

While Artificial Intelligence tools increasingly are being used across all industries to revolutionize customer engagement and drive business success, life sciences enterprises historically have been slow to adopt emerging technologies.

However, the life sciences industry is evaluating the potential impact of GAI for commercial functions. Let’s explore whether it will reshape the commercial technology landscape or if GAI will succumb to the inherent risks and challenges present in the life sciences industry.

The latest evolution in AI technology, GAI can create unique content in the form of text, images, audio, graphics, code, and more, in response to given prompts within seconds. Its versatile applications have captured widespread attention, with venture capitalists investing US $2.6 billion in 110 GAI-focused startups in the US last year alone.

One of the noteworthy demonstrations of GAI is the Chat Generative Pre-Trained Transformer (ChatGPT), launched by OpenAI, which has gained significant attention and received substantial investments, including a recent funding round of US$ 2 billion in January 2023.

The pandemic has transformed the life sciences industry’s commercial model, shifting from traditional in-person interactions to a hybrid approach that combines traditional and digital channels.

To attain a competitive edge, life sciences enterprises are prioritizing delivering hyper-personalized experiences to the end user. As a result, enterprises are prioritizing investments in data analytics and AI tools and are seeking domain-centric solutions over industry-agnostic solutions.

The commercial function serves as the customer-facing function for enterprises by engaging customers across multiple channels, potentially making GAI a highly valuable tool across the commercial value chain with a diverse range of applications and use cases.

Potential use cases of Generative AI in the life sciences commercial function

Enterprises’ primary focus is optimizing their commercial processes by leveraging AI tools to analyze large amounts of data, identify patterns, and generate actionable insights for the commercial function, thus driving business growth. However, given the strict industry regulations, human intervention/oversight remains essential for the overall usage of GAI.

Exhibit 1 illustrates the key use cases that enterprises are striving to unlock in the near term.

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Voice of the life sciences industry in adopting GAI tools in the commercial function

As enterprises explore the range of capabilities offered by GAI, the industry reaction is mixed. Some leaders express skepticism about the accuracy of the information generated, while others are optimistic about leveraging GAI tools to revolutionize customer engagement.

Most leaders believe the current state of GAI tools is not fully ready for adoption. But they anticipate it will play a pivotal role in the future in delivering a seamless omnichannel experience (integrating tools on chat, email, social media channels, etc.) and delivering personalized content (relevant content to customer persona). This will make GAI an integral tool to ease the ongoing transition to a hybrid commercial model.

Exhibit 2 highlights the various perspectives shared by industry leaders about using GAI tools in the commercial function of the life sciences industry.

 

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Please note: As ChatGPT is the most utilized GAI tool, we observe enterprises discussing it more, and over time, we will see a clear distinction between GAI tools and ChatGPT.

Recent activities fostering the adoption of Generative AI in the life sciences

Despite concerns raised by industry leaders, GAI-based tools hold significant potential for delivering compelling commercial benefits in the near term. With continuous technological advancements and extensive training of tools on diverse and reliable life sciences data models, these tools can provide enhanced support for the commercial function.

Life science commercial technology providers and services providers have made the following investments to kick off their GAI journeys:

  • Salesforce launched Einstein GPT, a GAI Customer Relationship Management (CRM) technology that delivers AI-generated content across various interactions, including sales and marketing functions at large scale
  • Veeva has integrated a new AI tool specifically tailored for pharmaceutical sales representatives into its platform. This tool enables sales reps to obtain precise information about physicians or hospital practices, empowering them to personalize their pitches
  • Axtria integrated GPT models into its proprietary products. For example, Axtria DataMAx, a cloud-based commercial life sciences data management product, leverages GPT to drive efficiency and productivity
  • Doximity, an online networking service for medical professionals, introduced DocsGPT, which leverages GAI to streamline healthcare personnel’s communication by addressing product-related inquiries, aiming to reduce reliance on sales representatives
  • ZoomRx, a strategic healthcare consulting company, has developed the Ferma platform adopting GAI to analyze data from medical conferences, benefiting pharmaceutical companies’ medical affairs functions. Some of its clients include Amgen, AstraZeneca, Biogen, and Merck
  • Microsoft has integrated ChatGPT into Azure to develop new GAI-based tools. In this collaboration, Microsoft brings its expertise in areas such as natural language processing (NLP), computer vision, and reinforcement learning
  • Cognizant launched the Cognizant Neuro®️ AI platform to assist enterprises in deploying GAI at enterprise scale

Enterprises are widely adopting GAI tools with ongoing efforts to address and resolve concerns related to privacy, potential racial bias in training data, and regulatory compliance.

Stay tuned for the second part of this series on generative AI in life sciences, where we will delve into the challenges enterprises face in adopting GAI tools, analyze the supply landscape, and share Everest Group’s perspectives on the roadmap for tool adoption.

To discuss generative AI in life sciences, contact [email protected], [email protected], and [email protected].

Continue learning about GAI in the webinar, Welcoming the AI Summer: How Generative AI is Transforming Experiences.

Will It Be Happily Ever after Post Veeva-Salesforce Divorce?

With the Veeva-Salesforce marriage splitting in 2025, can the two long-time partners remain business friends? Read on to learn what the end of this life-sciences CRM partnership will mean for each of the companies, enterprises, and customers.

The fairy-tale beginning!

Veeva and Salesforce are the front runners in the life sciences-focused customer relationship management (CRM) and commercial technology landscape, with their exclusive focus on Pharmaceutical and MedTech domains, respectively (with a solid non-compete agreement in place). Veeva originated as a spinoff from Salesforce with the potential to disrupt the pharmaceutical CRM space with cloud software. As such, Veeva CRM was built on the Salesforce platform, and Salesforce has been foundational to the building of Veeva ever since. Very soon after its formation, the newly forged Veeva team started developing life sciences-focused applications, spanning the life sciences value chain areas, on a new platform, Veeva Vault. This platform has an applications suite well-spread across the life sciences value chain areas. To date, most Veeva applications related to clinical operations, quality, regulatory, safety, etc., are hosted on Veeva Vault, while Veeva CRM (including solutions for customer experience management, multichannel engagements, and real-time insights) is hosted on Salesforce.

Mid-relationship crisis!

Too many risks added cracks to the Veeva and Salesforce partnership. Veeva, with its dependence on third-party IT infrastructure (Salesforce and AWS) for Veeva CRM, has always been wary of the risks associated with the partnership structure. Some of the highlighted risks include:

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Exhibit 1: Key risks associated with the Veeva-Salesforce partnership
  1. Suboptimal customer experience: Salesforce (and even AWS) have faced significant service outages in the past, and Veeva knows the repercussions this can have on overall customer experience
  2. Market/geography restriction: Veeva is highly dependent on Salesforce in terms of markets where it can sell its CRM. In addition to this geo-restriction, Veeva also will be left stranded if Salesforce exited any existing markets
  3. Domain expansion restriction: Veeva is legally restricted from expanding into the MedTech CRM domain (where Salesforce is the market leader). This puts a potential roadblock in Veeva’s future expansion strategy (and a possible limiting factor to achieving its goal of US$3 billion in revenue by 2025)
  4. Competitor product possibility: While the same agreement also limits Salesforce from selling its products in the pharmaceutical domain, it does not restrict Salesforce’s customer’s ability (or the ability of Salesforce on behalf of its specific customer) to customize or configure the Salesforce Platform to suit their pharmaceutical commercial operations. As such, Veeva’s current or potential customers can prioritize building custom applications over buying Veeva’s products
  5. High exit/platform shift cost: The cost of shifting the Veeva CRM to an alternate platform is exorbitant. In extreme scenarios, if Salesforce decides to annul the agreement on short notice, it will disrupt Veeva CRM and will massively affect all Veeva customers, leading to an indelible mark on the Veeva brand

The divorce!

In its Q3 earnings call for 2022, Veeva announced that it will not renew its Salesforce partnership when it expires in September 2025. As such, it will be moving the Veeva CRM to the Veeva Vault platform. With the agreement’s five-year wind-down period, existing customers can continue with Veeva CRM on the Salesforce platform through September 2030.

Implications for Veeva

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Exhibit 2: Implications for Veeva
  1. Superior customer experience: Veeva will be able to offer a better end-to-end experience to its customers with all the solutions and applications (ranging from the clinical and R&D areas to sales and marketing) hosted on a common Veeva Vault Platform. This also will let Veeva provide first-hand and more personalized service (hence, better SLAs) to its customers by leveraging a strong service partner ecosystem that includes partners across avenues (geographies, therapy areas, functions, etc.)
  2. Cost optimization: While Veeva stakeholders cite better customer experience as a key reason to move from the Salesforce platform to its own, a cost-related underbelly exists in this relationship – known as the “cost of subscription service.” This is the cost that Veeva has to pay to host its applications (including Veeva CRM) on third-party infrastructure (such as Salesforce and AWS). In 2022, this cost was equal to 12% of the total annual revenue. Moving Veeva CRM to Veeva Vault will let Veeva optimize this spend from its profit realization equation
  3. Growth: Veeva has outlined a very optimistic US$ 3 billion goal for 2025 (meaning a healthy growth rate of approximately 35% from 2022 to 2025). While its pharmaceutical-focused CRM business is expected to grow, with the Veeva-Salesforce relationship coming to an end, we can expect Veeva to foray into a MedTech-focused CRM as well. MedTech, although a much smaller part of the overall life sciences CRM pie, is touted to grow much faster than other domains. This can be a potential growth engine for Veeva to achieve its goals
  4. No access to Salesforce: Post 2025, Veeva will no longer be able to access Salesforce’s range of accelerators, tools, and partners. On the flip side, this is a potential opportunity for Veeva to beef up its capabilities in these areas. Additionally, with Salesforce out of the picture, Veeva will need to withstand enterprise expectations around scalability, value proposition, and change management

Implications for Salesforce

  1. Loss of revenue: Salesforce will lose the annual subscription service revenue stream coming from Veeva. However, since this amounts to less than 1% of total Salesforce revenue, we do not expect it to create a major dent in Salesforce’s annual revenues
  2. Opportunity to strengthen its life sciences product portfolio: Similar to Veeva’s opportunity to expand into the MedTech space (where Salesforce is the market leader), Salesforce will have the freedom to expand into the pharmaceutical CRM space (where Veeva is the market leader). This is a bigger opportunity of the two, given the larger size of the pharmaceutical CRM market

How should enterprises plan for the split?

Enterprises should start planning their next steps as the two companies go their separate ways. While customers may be concerned about the company’s move from Salesforce to Vault for the CRM offering, an extended period will be available to transition. By mapping out transition journeys today, enterprises will have a better chance for a seamless shift.

Enterprises also can now expect products from both Veeva and Salesforce in the MedTech and pharmaceutical spaces, so life sciences customers can plan out which product they want to run with. As the companies sever ties, however, enterprises will want to be more aware of rising pricing and licensing fees, making it plausible to look elsewhere if the price point and product are no longer a fit.

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Exhibit3: What should enterprises do?

1 Pharmaceutical includes pharmaceutical and biotechnology industries for human and animal treatments.

If you have questions about current CRM trends or would like to discuss developments in this space, reach out to [email protected] or [email protected].

Discover more about the current CRM landscape and explore customer experience strategies for life sciences enterprises in our webinar, How to Deliver Hyper-personalized Customer Experiences in Life Sciences.

Life Sciences Supply Chain Visibility: A Strong Link in the Chain | Blog

Improved supply chain visibility can help global pharmaceutical and medical device suppliers overcome the many logistics challenges they face post-pandemic. Internet of things (IoT) and blockchain technologies offer promise to address the growing demand for product traceability and transparency. Read our second blog in this series to learn more.

The COVID-19 pandemic exposed major supply chain weaknesses in the life sciences industry as the industry experienced skyrocketing demand for innovative medical products.

Enterprises struggled to keep operations running amid the pandemic without adequate supply chain product visibility or unified systems to provide needed data to improve logistics performance.

Most companies lack the analytical tools to completely integrate and analyze data from various systems at all levels – from the plant’s local work centers to the world’s end-to-end supply chain.

As a result, the massive data generated during the pandemic provided little usable information and insights.

Supply chain visibility: right time for real time?

Supply chain visibility can help enterprises overcome these challenges and build more robust and effective supply chains by tracking medical products in transit and providing a clear view of the inventory and activity.

Let’s look at the factors that are driving enterprises to invest in supply chain visibility.

  • Product loss and recall: Theft is costly to the industry and needs to be stopped. The pharmaceutical industry experienced its largest theft in 2020 when $1.2 million worth of oncology drugs were stolen from a cold storage warehouse. In the second largest theft that year, $600,000 in pharmaceuticals were taken from a distributor.

 The industry also is being hit by losses due to expired, non-compliant, or recalled products that have problems with temperature parameters or other issues. According to the U.S. Food and Drug Administration (FDA), 281 drugs and 50 medical devices were recalled during the two years of the pandemic

  • Counterfeit products: Increasing numbers of fake drugs and medical devices have found their way into customers’ medicine cabinets. Counterfeit drugs are valued at an estimated US$200 billion annually. Since the World Health Organization (WHO) established a global surveillance and monitoring system in 2013, it has received 1,500 reports of substandard or falsified products. Of these, antimalarials and antibiotics are the most reported. Geographically, 42% come from the African region and 21% each from the Americas and Europe.

Local regulatory frameworks are being implemented to provide more product visibility. For example, the Indian government has mandated life sciences enterprises include Quick Response (QR) codes on Active Pharmaceutical Ingredients (APIs), effective January 2023

  • Regulatory frameworks: The Drug Supply Chain Security Act (DSCSA), amended by the FDA in 2013, mandates enterprises to create an electronic system to track and trace certain prescription drugs. Manufacturers and trading partners are required to encode their products with unique identifiers on the individual packages and track products at the unit level by November 2023.

Similarly, the European Union (EU) Medical Device Regulation (MDR), which regulates the production and distribution of medical devices, mandates MedTech enterprises place a Unique Device Identifier (UDI) for better visibility and tracking of products across the supply chain

A recent analysis found the top 15 global pharmaceutical companies emit 55% more greenhouse gas emissions per million dollars of revenue than the automotive sector. Medical waste has also become a significant issue, particularly with the spread of single-use personal protective equipment and testing kits. As a result, life sciences enterprises are taking initiatives to build more transparent supply chains to track and trace carbon emissions, medical device decommissioning, and secondary package waste

Everest Group’s view of end-to-end supply chain visibility solutions

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Let’s explore more on the supply chain visibility framework:

  • Make/Manufacture – Inbound logistics that includes procuring raw materials, drug packaging, and moving finished goods to the supply chain

Use Cases: Addressing drug serialization and aggregation, strategic sourcing, fleet tracking, drug e-labelling, artwork management, and API tracking

  • Deliver – Outbound logistics that include order confirmation, shipping, last-mile delivery, and customer service

Use Cases: Addressing drug expiry monitoring, network management, demand forecasting, and warehouse management 

  • Stakeholders experience – Unifies vendors, suppliers, distributors, pharmacies, patients, and others in the life sciences supply chain with one platform 

Use Cases: Asset tracking, anomaly detection, and condition monitoring alerts

  • Returns management: Communicating with end-customers, stakeholders, and life sciences enterprises to obtain and restock goods. Having visibility of goods in reverse logistics helps enterprises make calls on whether to discard, repurpose or recycle drugs and medical devices

Use cases: Case and compliance management, returns tracking and scheduling, conditional monitoring alerts, and drug serialization

Service provider landscape

IT service providers are increasingly offering solutions to address these needs as these instances gain traction. One example is HCL’s serialization and authorization solution that helps track product returns in real time.

Recognizing the need for greater insights into supply chain performance, enterprises have invested in Enterprise Resource Planning (ERP), Laboratory Information Systems (LIMS), Electronic Batch Records (EBR), Manufacturing Equipment Systems (MES), Quality Management Systems (QMS), and other IT systems to capture transactional and performance data.

Information sharing, data interoperability, security, and trust are the major hurdles for life sciences enterprises to implement supply chain visibility solutions. Blockchain and the Internet of Things (IoT) offer promising prospects to tackle these challenges by maintaining the continuity of information, realizing the link between physical and information flow, and providing fraud detection alerts.

IBM, KPMG, Merck, and Walmart successfully completed an FDA pilot program in 2020 that found blockchain technology can be used to meet the DSCSA requirements to track and trace prescription drugs and vaccines distributed in the U.S.

We recommend life sciences enterprises partner with IT service providers that have point solutions for supply chain visibility or engage with niche platform providers to build end-to-end supply chain visibility solutions.

Keep following this space as we explore the technology in supply chain visibility platforms, and see our prior blog on Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities.

What are your views on life sciences supply chain visibility? Reach out to [email protected] and [email protected] to discuss.

You can also learn about planning for a sustainability in your organization in our webinar, Sustainability and the CIO’s Office: A Powerful Connection.

Five Factors Transforming the Life Sciences Supply Chain and Creating IT Opportunities | Blog

Supply chain visibility, strategic sourcing, cold chain requirements, sustainability demands, and personalized medicine are creating opportunities in the life sciences supply chain for IT partners delivering digital solutions. Read this first part of our blog series to understand the shift that is underway.

New security requirements, industry mandates, and changing customer needs require the contemporary life sciences supply chain to become more efficient, transforming the logistics network.

The worldwide value of pharmaceutical goods traded has grown six-fold in the past two decades from US$113 billion in 2000 to US$629 billion in 2019, according to the United Nations Comtrade Database.

This growth has driven more companies to outsource production to Contract Manufacturing Organizations (CMOs) to meet the pent-up demand. Let’s explore the factors impacting these increasingly global and complex chains.

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  • Pandemic-driven supply-demand fluctuations: Rising consumerism and pandemic-driven proliferation of precision medicines, wearables, and telehealth applications have left enterprises struggle to meet increased demand. One example of this is Bristol Myers Squibb’s struggling to meet the strong demand of BCMA-targeted CAR-T cell therapy Abecma
  • Ever-changing regulatory oversight: Many industry-wide regulations have been implemented to strengthen the safety and effectiveness of medical devices and drugs commercialized across the globe. These include the European Union Falsified Medicines Directives (EU FMD) in 2011, Drug Supply Chain Security Act (DSCSA) in 2013, European Union Medical Device Regulation (EU MDR) in 2017, and the UK Medicine and Medical Devices Act (MMD) in 2021
  • Need to reduce product diversion and recall: Increasing numbers of black-market activities and illegal drugs are finding their way into the supply chain and affecting companies’ brand values. The most common drug diversions are class benzodiazepines, opioids, stimulants, antipsychotics, anesthetic drugs, and GABA agonists
  • Supply chain data sharing and data security: Broad threats, ranging from cybersecurity to data breaches, have led to unplanned financial and intellectual property losses. A case in point: IBM detected cyberattacks against the cold chain drugs specifically associated with GAVI, the vaccine alliance, and government agencies involved in the drugs’ distribution

Five key investment areas in the life sciences supply chain

  1. Supply chain visibility: Implementing visibility platforms could have saved 1 billion vaccines during the pandemic, according to the United Nations Environment Programme. This creates opportunities for IT service providers to partner with enterprises to enable end-to-end supply chain track and trace models.

Additionally, the Drug Supply Chain Security Act (DSCSA) outlines requirements to achieve interoperable, electronic product tracing at the package level to identify prescription drugs distributed in the United States by November 2023. Similar laws are in effect in Europe and other parts of the world. (For more on supply chain visibility, see our next blog.) 

  1. Strategic sourcing: With the growing awareness post-pandemic of the supply chain risk of overdependence on raw material procurement from India and China, enterprises are starting to reshore pharmaceutical manufacturing in the US and Europe. 

Also, since sourcing and procurement account for roughly half of drug development and manufacturing costs, firms are focusing on optimizing spending by using technology to gain real-time spending views, structure budget accountabilities, and align purchasing with production

  1. Emerging cold chain requirements: Various factors have pushed enterprises to increase their focus on temperature-sensitive drugs that contain high-value active ingredients and have shorter shelf lives. Cold chain adoption also has been accelerated by the rapid growth of consolidated distribution houses and online retailers’ improved last-mile connectivity 
  1. Sustainable supply chains: The growing importance of sustainability initiatives is evident from the surge we have seen in Environment, Social and Governance (ESG) report. ESG funds in biopharma companies increased 27% in 2021 from the prior year.

Sustainable secondary packaging, carbon footprint tracking, responsible raw materials procurement, effective medical device decommissioning, and scrap minimization are gaining more traction in the life sciences industry. Additionally, the European Union directive 94/62/EC, in conjunction with directive 2018/852, demands a significant reduction in packaging waste by 2025 

  1. Supply chain tailored to personalized medicine: Specialized logistics partners are needed to handle the extremely delicate and patient-specific components of innovative and personalized medications – from collecting cells/genes from healthy donors to delivering innovative medicine to patients.

Life sciences enterprises have invested approximately US$ 13 billion in cell and gene technologies since 2018. More than 900 enterprises worldwide are developing cutting-edge advanced therapeutics, and approximately 1,000 advanced therapy clinical trials are underway. This changing landscape requires supply chains that provide temperature-sensitive environments, closed loops, Chains of Identity (COI), and Chains of Custody (COC)

Implications for service providers

In response to these factors, next-generation connected supply chain ecosystems are beginning to emerge. Life sciences enterprises will need the right complementary digital technologies to optimize costs, drive productivity through streamlined route selection, and improve the customer experience.

This will create new opportunities for IT service providers that bring niche talent and a balanced portfolio of engineering and digital services, as well as supply chain-specific platform providers who will become partners of choice for life sciences enterprises.

Follow the second part of this blog series as we explore supply chain visibility platforms and enterprise initiatives.

To share your views on the life sciences supply chain, please reach out to [email protected] and [email protected].

For more details on the service provider outlook, watch our webinar, Outsourcing Services Pricing: What to Expect Next.

Increased Deal Activity in Revenue Cycle Management (RCM): What is the Winning Formula? | Blog

Health systems are increasingly seeking competitive proposals post-pandemic to outsource Revenue Cycle Management (RCM) and get the best prices and innovation in contracts. Learn what enterprises want and how providers can win these RFPs. 

Why has outsourcing gained traction in the Revenue Cycle Management (RCM) market?

The hospital revenue cycle process was not immune to the many changes COVID-19 brought to the US healthcare provider ecosystem, causing health systems to significantly shift operations to survive.

Challenges such as financial pressure, regulatory changes, the quality care and patient experience focus, and digital penetration pushed health systems – who traditionally prefer to keep operations in-house – to look outside for support. This drove more than 10% year-over-year growth in sourcing in the RCM market in 2021, and the strong contracting activity continues to gain traction this year.

Several health systems, including MarinHealth, Baptist Health, SSM Health, and Bassett Healthcare, have entered into outsourcing agreements with third-party vendors. However, unlike most past arrangements when sole-source was the dominant sourcing model, RFP-led sourcing is now the preferred model for healthcare providers in the post-pandemic world.

Exhibit 1: Split of new Revenue Cycle Management (RCM) services deals in 2021 – sole-sourced versus RFP-led

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Source: Everest Group’s coverage of 32 major RCM services outsourcing providers

Why do healthcare providers prefer RFPs?

Key factors driving health systems towards a competitive route over sole-sourced are:

  1. Unlike the pre-COVID era, when outsourcing was, typically, limited to a revenue cycle function or segment, the new deals coming in the Revenue Cycle Management (RCM) market are broad-based and many times encompass the end-to-end revenue cycle needs of healthcare providers. Given the size and scale of such deals, healthcare providers prefer the competitive route to get the best possible deal
  2. While cost used to be the primary decision-making driver, health systems are now emphasizing deal aspects such as innovative pricing (wanting third-party providers to have skin in the game) and offering diversified delivery network, innovation pool commitment, and compatibility with existing infrastructure, including experience of working with platforms such as Epic
  3. With hundreds of outsourcing providers in the RCM market, health systems know they can shop around to get the best deal

Key decision-making parameters for health systems in a competitive bid

Healthcare provider enterprises are looking for service providers who can provide end-to-end services covering the entire gamut of Revenue Cycle Management (RCM), rather than discrete, siloed services.

From a decision-making perspective, below are some of the key parameters that enterprises look for when selecting a potential service provider, along with their relative importance rated on a scale of 1 to 10:

Exhibit 2: Level of importance of key buyer decision-making parameters for outsourcing Revenue Cycle Management (2021)

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Source: Everest Group’s coverage of major Revenue Cycle Management (RCM) providing enterprises

Service providers need to pay special attention to how they position themselves effectively in the extremely competitive RCM market. The two main levers determining a winning proposal are:

  1. High-quality, well-structured proposals that demonstrate a deep understanding of the client’s needs
  2. Commercial proposals that are well aligned with the client’s budget and offer flexible payment terms

 

As competitive RFPs rise in the RCM market, providers who can create a differentiated value proposition and align their strategies with the enterprise’s vision will succeed in securing these lucrative deals.

To discuss Revenue Cycle Management (RCM) reach out to us at [email protected], [email protected], or contact us.

Learn more about RCM operations in the healthcare industry in our video, Revenue Cycle Management RCM Operations – Emerging Opportunities & Strategies.

Understanding Strategic Investments by Decentralized Clinical Trials (DCT) Product Vendors | Blog

COVID-19 put the spotlight on Decentralized Clinical Trials (DCTs) that will last well beyond the pandemic-stricken years as the industry increasingly adopts digital solutions for conducting remote, virtualized, or decentralized trials. In this digital ecosystem, vendors need to focus on several strategic areas to provide a holistic DCT experience and stay ahead of the competition. Discover in this blog the five priorities that can help product vendors take the lead in the DCT ecosystem.

Decentralized clinical trials rose to popularity during the pandemic. As people around the world were advised to stay indoors, sponsors and Clinical Research Organizations (CROs) scrambled for an alternative solution. DCTs catapulted to the mainstream and disrupted the clinical trial landscape.

DCTs offer reduced dependency for on-site visits, increased patient convenience, and improved insights from real-time patient data. While the pandemic may slowly subside with increased vaccinations, decentralized trials are here to stay – continuously elevating the trial experience for patients, sponsors, and investigators.

Everest Group’s Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found improving patient recruitment and retention are the top reasons behind sponsors adopting DCT solutions.

With DCT adoption growing significantly, sponsors have varied sourcing criteria based on their priorities. We have observed that large biopharma companies prefer a unified platform while mid-and small-sized players are more interested in cost as their top sourcing criteria for DCT vendors.

Biopharma companies want vendors who feel the market pulse and offer tailor-made deal solutioning for increased DCT adoption, as illustrated below.

Sourcing criteria for selecting DCT vendors

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Five focus areas for DCT vendors to enhance their value proposition

To increase DCT adoption and run trials holistically, sponsors and CROs require matured technology products as well as auxiliary services. Hence, DCT vendors should not only strengthen their product offerings but also up their game in delivering auxiliary services.

With the exponential rise in DCT adoption, new players are rapidly entering the DCT landscape. In this marketplace, how can vendors offer value and stay on top of the competition? Our analysis reveals the following five areas that can help DCT vendors elevate their offerings above others:

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  • Inorganic growth – Considering the speed of digital disruption in the clinical trial landscape, inorganic growth is the fastest way to grow and expand capabilities. Technology-based DCT product vendors are focusing on improving their consultative positioning by combining high-tech and high-science under one platform. Two recent examples are THREAD acquiring Modus Outcomes, an organization that supports eCOA selections, designs patient-centric trials, and fosters scientific delivery of DCTs. Similarly, Clinical Ink acquired Digital Artefacts to enrich the data coming from patient-reported outcomes with situational awareness and active and passive digital assessments

 

  • Partnerships – DCT product vendors increasingly seek to partner with specialists to enhance the delivery of auxiliary services. These unions aim to increase trial efficacy and eliminate risks and delays while improving the experience for patients and site practitioners. Some recent deals include Science 37 collaborating with Foundation Medicine to accelerate the patient selection process for oncology trials. THREAD has entered alliances with Almac Clinical Technologies to reduce trial delays and risks and also with endpoint Clinical to simplify trial operations for site personnel

 

  • Human capital development – Investments in human capital are either focused on designing a simple unified platform for seamless patient experience during trials or on expansion and marketing operations. This has led product vendors to add new positions like Chief Growth Officer, Chief Design Officer, Chief Strategy and Expansion Officer, etc. Medable, Science 37, THREAD, Castor, and ObvioHealth have made significant investments in hiring or opening multiple roles directly or indirectly related to DCT solutions to expand their services and establish strategic partnerships

 

  • Funding – Multiple DCT vendors have raised significant funding to enhance their DCT program. Science 37 has recently become a public-listed company, thereby making enough funds available for DCT expansion and growth. On the same lines, Medable has secured a US$ 304 million Series D funding, taking the total company valuation to just over US$ 2 billion. It plans to use the funds to improve access to clinical trials worldwide and accelerate new drug development. ObvioHealth had raised US$ 31 million in its latest round of funding, while Castor raised US$ 45 million in its series B funding. While ObvioHealth plans to direct funding to enhance its proprietary IT capabilities and make new hires, especially keeping in mind the APAC region, Castor is focusing on accelerating trials and maximizing the impact of research data on patient lives. These activities clearly echo the positive investor sentiments towards DCT solutions

 

  • Geographic expansions – Enterprises are looking for studies that are global or beyond the North American (NA) region, pushing DCT vendors outside their established geographies into the Europe, Middle East, and Africa (EMEA) and Asia Pacific (APAC) markets. Both THREAD and Medable have established offices in Dublin, Ireland to expand their presence and grow the market for decentralized trials in the EMEA region. ObvioHealth has partnered with Anatara Lifesciences to launch DCTs in Australia, and Science 37 has partnered with CMIC Holdings to enable and advance its DCT offerings for Japan and the APAC region

The age of decentralized trials has begun, and sponsors are shifting away from the site-anchored approach to hybrid or completely decentralized trials. They are looking to convert their piecemeal deployments into a comprehensive strategy aimed at enhancing the trial experience for patients, sponsors, and CROs.

To cater to this rising demand, DCT product vendors need to leverage advancements in digital technology and enhance their value proposition. With a deep focus on inorganic growth, partnerships, human capital, funding, and geographic expansions, providers can offer a seamless DCT experience in 2022 and well into the future.

What areas should product vendors focus on to stay ahead in the DCT ecosystem? Reach out to [email protected] and [email protected] to discuss.

Explore more information about DCT adoption trends and providers. Learn more

The Future of Decentralized Clinical Trials Starts with a Patient-first Design Approach | Blog

The biggest benefit of Decentralized Clinical Trials (DCT) is the opportunity to enhance the patient experience, but the process is rife with challenges that create disengagement. The problem is not that patients are unengaged, but rather the vendor products are not always very engaging. The solution lies in undertaking a patient-first approach. Discover the tenets of a patient-first design approach in this second blog in our continuing coverage of this timely topic.

The pandemic has propelled decentralized clinical trials (DCT) into the mainstream, and multiple enterprises have transitioned into the virtual model for conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model. What do enterprises mean when they talk about patient experience? Read our blog, How Decentralized Clinical Trials Put the Patient Experience at the Forefront, to find out.

To deliver a superior patient experience and derive maximum benefit from this model of conducting trials, enterprises and vendors must be aware of the patient-facing challenges that might pose major hindrances. A closer look at the top challenges will help businesses develop effective measures to improve patient engagement and retention.

Major patient-facing challenges

The entire remote model has reduced in-person interactions. Insufficient communication from sites and sponsors often leads to disengagement among patients. The human touch, an important psychological aspect in healthcare, goes missing in this model. Added to this is the burden of learning about new products and technologies.

Patients have very limited digital literacy and may find it extremely difficult to operate a new sensor, a smartphone, or an application. Vendors are struggling to develop  robust training and support programs while enterprise buyers are more concerned about patient education capabilities and post-implementation support in their sourcing criteria.

All these factors create a general sense of discomfort and disengagement among patients, thereby defeating the principal benefit that vendors and enterprises expect from a DCT solution.

How can vendors overcome patient-facing challenges?

Designing a patient-centric solution is the best way to address these challenges. Having a deeper understanding of patients’ journeys and their pain points, while involving them in solution design will lead to greater compliance and engagement. The following exhibit highlights the various tenets of a patient-first solution.

Exhibit 1: Tenets of a patient-first design approach

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Six aspects of a patient-first design approach

  • Empathetic: DCT solutions should portray a deep understanding of the needs, well-being, and interests of patients, fostering trust and emotional connection. Vendors need to map the entire trial journey and look at it more holistically rather than logistically. Incorporating patient feedback into designing solutions will reduce a lot of stress and burden on patients
  • Secured: Concerns with data security, compliance, and privacy have increased with the rise in DCT adoption. Patients fear the consequences of device and network hacking, data leaks, and unauthorized access to data. DCT vendors must incorporate stringent security and compliance measures, secure the networks, and prevent all types of unauthorized access. With precise security measures in place, patients will feel safer with their data and will be more willing to share data for clinical research
  • Adaptable: DCT solutions must be able to incorporate the changing patient context, needs, and preferences to build fluid experiences. The same solutions should be adaptable and scalable as per the study requirement, ensuring a consistent patient experience and providing long-term sustainability
  • Engaging: Delivering engaging content is the best way to keep patients motivated in this digital world. Interactive educational materials, timely communication of trial progress (lay summaries), and patient reports go a long way in increasing patient engagement and retention. Patients can be motivated by increasing their trial literacy, setting up patient advocacy boards, and rewarding them for their contributions to the trial
  • Personalized: A one-size-fits-all solution will not work as patient experience varies at each stage and with each individual. Individualized care and personalized solutions help in building trust, loyalty, and retention rates among patients. Giving patients the liberty to choose their treatment plans (wherever possible), creating patient-specific digital ads, and supporting patients via artificial intelligence (AI) assistants are some of the ways to incorporate personalization into clinical trials
  • Reciprocity: Patients, vendors, and enterprises should be encouraged to communicate and share relevant experiences. Beyond trial periods, vendors and enterprises can engage patients with information on lifestyle, new developments on drugs or medical devices, upcoming trials, diet plans, etc. This type of communication will increase the willingness among patients to share personal data with AI systems as well as the scope with vendors, leading to more customized solutions that promote relevant and progressive experiences

Patients do not want to be treated as mere statistics. They want the touch of empathy and personalization, pushing DCT vendors to think more ‘humanly’ and add ‘emotional’ content while designing DCT solutions.

When all the above elements are incorporated in building DCT solutions, it will not only increase participation and adherence but also improve the brand value and bottom line for DCT vendors.

Over and above the empathy-backed approach toward creating a patient-centric solution, DCT vendors and enterprise buyers can look further at certain initiatives aimed at improving patient experience.

A sheer lack of awareness among patients regarding ongoing or planned trials exists. Enterprise buyers and vendors should spread information about upcoming clinical trials and steps to participate in them while promoting the ease of using digital technologies (via social media, newsroom, public releases, etc.). Home-care nurses or physicians still must make monthly calls or visits to motivate patients and add some scope for face-to-face interactions between patients and healthcare professionals.

Though the pivot or the integral enabler for DCT solutions is technology and connected systems, the focus should be on improving the patient experience and building the future towards a patient-intuitive smart DCT solution suite.

What are your views on how businesses can improve the patient experience? Reach out to [email protected] and [email protected] to discuss further.

Interoperability in Healthcare – Key Regulatory Implications and Beyond (Part 2) | Blog

The CMS Interoperability and Patient Access final rule has enabled key healthcare stakeholders – payers, providers, and health IT vendors – to realign their strategic goals and work toward enhancing member engagement and care delivery.

While interoperability in healthcare can deliver numerous benefits, complying with the rules can be complex and we are closely tracking this issue. In our earlier blog, we covered the evolution of interoperability over the years, the interoperability rule, and the challenges enterprises face in deciphering this regulation.

Read on for part two in our blog series that focuses on the data sets that need to be shared, steps involved in the data sourcing process, and the areas enterprises must focus on to navigate through the interoperability rule.

Which data gets shared as part of the interoperability rule, and what is the data sourcing process?

The interoperability rule has mandated payers to share across member- and plan-level information with the help of two Application Programming Interfaces (APIs) – patient access and provider directory. The rule also clearly identifies distinct data sets that need to be shared through both the APIs, as illustrated below.

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Having discovered what data needs to be shared, the next big question for enterprises is understanding how to extract this data. To make the necessary data available to its members through open APIs, enterprises primarily have to perform these three key steps: source system identification, data mapping, and data transformation.

  • Source system identification: As healthcare organizations store member information across multiple systems such as claims management system, Electronic Health Records (EHRs), etc., the primary objective is to identify the right source systems that house the information needed to be shared through the APIs
  • Data mapping: Data elements mandated by CMS are populated across various Fast Healthcare Interoperability Resources (FHIR) profiles such as patient profile, practitioner profile, etc. These data elements must be mapped against the respective source systems by matching the fields from the source database to the target database
  • Data transformation: FHIR profiles consist of data elements with attributes such as cardinality, data type, and binding value sets. The mapped data will have to be transformed into the FHIR recommended format by adhering to the data attributes (for example, translation of system codes into industry-specific codes, usage of industry- standard unique identifiers such as National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) number, etc.)

 How do enterprises navigate through the CMS interoperability rule?

Although the interoperability rule defines IT investments payers, providers, and Health Information Technology (HIT) vendors must make, enterprises also need to plan for other critical aspects such as infrastructure scalability and data security in parallel. These areas will be crucial given the increasing data volume and demand for more streamlined services around data access and utilization.

The exhibit below illustrates the key IT remodeling themes and corresponding transformation levers for interoperability implementation in a healthcare enterprise.

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FHIR-based API ecosystem

The interoperability rule states that healthcare enterprises should establish API interfaces for all systems handling member/patient data and that the data transferred among healthcare entities – including the member/patient – should be in a standardized format. A robust API-led interoperability strategy can help healthcare enterprises curb the data liquidity issue within their ecosystems. The FHIR-based APIs will enable data format standardization between different endpoints, decrease development time, and save storage space on endpoint devices.

But just creating and establishing FHIR-based APIs will not suffice. Enterprises need to integrate and orchestrate formats other than FHIR. While connectivity with standard or off-the-shelf systems will be easier, homegrown/custom systems will be challenging to map to FHIR standards. In-house development teams and technology vendors will have to create workarounds to modify existing components that consider the potential variability in medical terminologies.

Infrastructure layer

With the implementation of FHIR-based APIs, enterprises must assess scalability challenges within their existing infrastructures. To accommodate the upcoming member/patient data access requests and enable quick data retrieval, enterprises should start to manage their current data storage and compute capacities. Enterprises can approach the data scalability and infrastructure issue by either leveraging existing infrastructure to build an FHIR-based layer or partner with technology vendors to leverage their data, cloud, or FHIR platforms.

Security layer

As healthcare enterprises will have access to multiple data sources, healthcare interoperability might open the door to security breaches and cybersecurity threats that may not have existed if the data resided within the enterprise. With the influx of data from other healthcare entities, current standard security checks might not be able to cross-reference and validate the identity of the entity requesting access, creating openings for data breaches. To manage these security challenges, added investment in particular focus areas (e.g., application penetration testing, consent management, member education) can help enterprises achieve sustainable data security.

The road ahead

While enterprises are complying with the CMS mandate, an increased focus must be put on how they can look beyond regulations to address some of the key pain points in the industry, such as patient experience, care management and outcomes, and total cost of care. With data flowing seamlessly across the healthcare ecosystem, enterprises should identify and invest in areas that would be crucial to creating long-term business value while also giving them a competitive edge.

As part of our third blog in this series, we will next cover how healthcare enterprises can approach the interoperability rule beyond the mandate to reap long-term benefits, key investment areas, value for enterprises, and an interoperability enablement framework that provides a view into the required IT components for regulatory compliance and what goes beyond regulation.

Please feel free to reach out to [email protected] to share your experience and ask questions.

How Decentralized Clinical Trials Put the Patient Experience at the Forefront | Blog

How Decentralized Clinical Trials Put the Patient Experience at the Forefront

With the COVID-19 pandemic accelerating the adoption of Decentralized Clinical Trials (DCT), the opportunity to deliver a patient-centric experience is viewed as a top benefit of this alternative mode of clinical trials that uses digital and remote technologies. What factors are enterprise buyers looking for DCT vendors to provide in their platforms to increase satisfaction and ultimately drive patient enrollments? Learn about the five factors that go into a “patient centered” experience in this blog.

When COVID-19 brought traditional clinical trials to an abrupt halt, Decentralized Clinical Trials (DCT) proved to be a savior for sponsors looking to safely restart their paused research activities. While DCTs have been around for a decade and are slowly gaining traction, the pandemic accelerated the use of these alternative methods to collect clinical trial data through sensors or remote monitoring devices carried by a patient.

The top reason for moving toward this model has been its patient-centered focus that makes it easier for more people from a broader geographic area to participate in trials without the need to visit a site.

The growing mainstream acceptance for DCTs has increased the appetite among clinical research organizations (CROs) and sponsors to adopt the latest technologies and virtual models for clinical trials. This has resulted in an uptick in innovation and DCT product adoption recently. We see DCT vendors increasingly focus on co-innovation, continuous product improvement, and market education to help clients get started on their DCT journey.

Top benefits of DCT adoption

Our Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found the most promising benefit for enterprises to consider decentralizing their trials is the opportunity to enhance the patient experience – a benefit that two out of three DCT product buyers also agree with based on Everest Group interviews. Other advantages of DCTs include reducing trial costs and timelines, attracting a more diverse patient population, and capturing real-time data for trials.

With DCTs, patients can now take part in a study from the comfort of their homes, spend more time with their family members, and focus on work and other responsibilities. This mode of clinical trial also opens the door to the patients who suffer from mobility issues and allows sponsors to reach a global audience, increasing inclusivity and diversion.

This new patient-centric approach is driving increased enrollment and retention rates. With these valuable benefits, it is not surprising that having a people-orientated platform has become central to enterprise buyers in making their sourcing decisions – even more so than innovation or reviews from other buyers.

What do buyers want from DCT vendors?

What do enterprises buyers mean when they talk about patient experience? Multiple facets contribute to the notion of patient experience as presented in the exhibit below.

Exhibit 1: What enterprises buyers mean when they say patient experience

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Five factors to enhance patient experience with DCTs

Patient experience can be broken down into the following aspects:

  • User-friendly interface – The User Interface (UI) of DCT applications and devices must be simple, yet effective. They must provide clear instructions and display only relevant and concise content. It should be well organized, making all options easily accessible and ensuring that the application can be used with minimal explanation
  • Easy to set up platform/app – Patients should have an easy time setting up a wearable, sensor, or application. It should be intuitive even to an average user with limited exposure to digital devices. The device should be as close as possible to a ready-to-use mode
  • Smooth operation – The applications or devices should not pester patients with unnecessary notifications, malfunctions, or failures that would cause unwanted frustrations, resulting in reduced patient engagement. A smooth operation with minimal or zero disruption is the best-case scenario
  • Robust education and training – Patients come with different levels of digital literacy, and they need to be supported during the trials. They must be aware of how to enroll themselves for the trial, schedule appointments, feed in data, and get important information about their health and the trial. Sponsors can create the knowledge pool, conduct training sessions, and build artificial intelligence (AI) bots to provide education and training to patients
  • Multilingual app and support – To reach a global audience, multilingual offering and support must be available. The devices or applications used should provide instructions and information in the commonly used languages across the world. If a trial is geographically focused, the regional language should be configured in the device

Enterprises want DCT solutions to integrate smoothly into the daily lives and operations of patients. Patients should not feel isolated when doing the trial since the significant amount of digital literacy required might deter them from participating.

Vendors also need to be aware of the top patient-related challenges that might hinder them from elevating the patient experience through their products and services. Multiple challenges might lead to an inferior experience, resulting in disengagement and dropouts. DCT vendors and enterprise buyers must identify these challenges and take discrete steps to improve the patient experience and engagement.

Keep following this space as we dive into the top patient-related challenges and present initiatives aimed at improving the patient experience.

What are your views on the patient experience in DCTs? Reach out to [email protected] and [email protected] to discuss more.

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