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Data sharing in biomedical research has recently attracted widespread attention from physicians, scientists and stakeholders alike. DCRIs Dr. Eric Peterson discusses the context, flaws and positives of how this initiative could be implemented and the effects it can have on the industry.

Putting Our Shoulders to the Wheel: Thoughts on Data Sharing

Despite the benefits of their evidence-based data, RCTs have several disadvantages.

The Promise of Pragmatic Clinical Trials for Improving Clinical Care

Video interview with Sepehr Shojaei, VP, Design Solutions, Lightship

Lightship's Approach to Accessible, Representative, and Impactful Clinical Trials

Lightship prioritizes patient accessibility and centricity in clinical trials, ensuring a seamless and positive experience for every participant. Learn more about:

Lightship's mission and core purpose as a company

How Lightship’s mobile nursing teams and home visits enhance study participation and retention

The role of mobile research units in the community and how they enhance participant education, accessibility, and convenience

Sepehr Shojaei, VP of Design Solutions at Lightship, talks about how the company works with pharma and contract research organization (CRO) partners to support clinical trials that are patient-first and accessible.

Latest Conference Coverage

Lightship’s Approach to Accessible, Representative, and Impactful Clinical Trials

Video interview with David MacMurchy, CEO of Lightship

Accelerate Inclusive Enrollment and Delivery with Lightship

Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more about:

Lightship's impact on achieving diversity in clinical trials by engaging underrepresented patient populations

How Lightship utilizes hybrid and decentralized trial designs to reduce patient burden

The impact a patient centric model has on clinical trial participation and outcomes

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials. 

The desire to have greater control over clinical trial payments and strengthen relationships with investigator sites is driving some trial sponsors to consider bringing these responsibilities in-house using a software-as-a-service solution. However, such SaaS solutions are not a panacea for the complexities and requirements of clinical trial payments. This is why a hybrid approach makes sense for many sponsors.

When sponsors bring clinical trial payments in-house, they take on the full scope of that work. Certainly, a SaaS solution will do some of the heavy lifting, such as crunching the data and calculating payments owed to sites. But sponsors also need to manage the various technical and compliance challenges of clinical trial payments, which can require them to obtain resources for administering site payments globally as well as following country-specific processes and policies.

With the right balance of insourced and outsourced payment activities, sponsors can receive all the benefits of a SaaS solution while minimizing the risks and burdens that come with managing global investigator site payments internally.

Key considerations when insourcing payments

The main appeal of a SaaS solution is its ability to quickly and accurately determine site payments.

The solution should be able to consume all patient-visit and related clinical data, apply the financial terms for each site’s clinical trial agreement (CTA), and accurately calculate payments. The solution should also have an intuitive interface for sites to upload invoices and supporting documentation for CTA items that require it, such as archiving and pharmacy fees. Financial information should also be easily viewable for both the site and the sponsor in real time.

By doing this using a SaaS solution internally, the sponsor can own more of that crucial site relationship. For instance, if a site has a question about a specific payment or needs support at any time, they can contact the sponsor instead of a third-party managing payments. In addition to strengthening site relationships, this can help sponsors advance sponsor-of-choice initiatives.

However, the wrong SaaS solution can negatively impact site relationships.

Investigator sites are overburdened with technology provided by sponsors to support clinical research activities. They often use different portals for entering clinical data, tracking payments and getting regulatory approval to see patients. This challenge is exacerbated when sites work with multiple sponsors that each have their own technology preferences.

This is why it’s crucial that sponsors prioritize the site experience when selecting a solution.

For instance, a platform should make information readily available and easy to understand. It should automate as much of the payment-related work as possible, such as uploading invoices, reconciling final payments and managing accruals. 

For sponsors, it’s important to remember that a payment platform doesn’t operate in a vacuum. Its success depends on its ability to integrate with other systems, including clinical trial management systems, electronic data capture systems and financial systems. A SaaS solution that eases these connections, such as with API integration capabilities, can help sponsors save time and avoid headaches.

Sponsors shouldn’t wait until they bring payments in-house to understand how that change will impact staffing, internal processes and compliance or their associated costs. Instead, sponsors should conduct readiness assessments to identify these needs in advance.

A readiness assessment can reveal where a sponsor will need to revise roles. For example, they may need to adjust existing customer-facing positions to provide payment-related support to sites. Or they may need to create new roles to clean data so it can be processed by a payment system.

Understanding these impacts can help sponsors identify the payment responsibilities that may be too complex and costly for them to take on internally – and where outsourcing can be a lifesaver.

Facilitating payments across borders is a prime example of an activity that sponsors may want to outsource.

Countries around the world have unique requirements that must be met to successfully make investigator site payments. Some governments, for example, require that paying entities have a physical presence in their country. And in some cases, it can take several months to complete the work and secure the necessary regulatory approvals and bank relationships to meet just one country’s requirements.

Instead of putting this burden on their accounts payable departments, sponsors can give this work to a partner that already meets the requirements and has established banking relationships in the countries they need to pay into. This partner can do a final validation of payments and then handle all aspects of disbursing those site payments in each country.

Similarly, a trusted partner with global experience can help a sponsor use the optimal country-specific language that should be included in their global clinical trial agreement templates. This can help enable a smooth payment experience for both the sponsor and site, and support compliance with regulations that cover such things as research credits or value-added tax. The same partner can also help the sponsor comply with payment disclosure or “sunshine” laws in countries that have them.

All these areas where a third-party partner can offer support may not be immediately obvious to a sponsor. But when needs are identified through a readiness assessment, a partner can help sponsors avoid costly payment-related delays and disruptions.

Even with the assistance of a third party, the transition to managing payments in-house won’t always happen overnight. Sponsors may benefit from phased or managed migrations.

This can be an opportunity for the sponsor to learn and get comfortable with the new processes required by their SaaS solution while they continue to outsource payment-related activities. During this transition, their third-party partner can play the role of a consultant, answering questions and helping the sponsor ease into their new processes as payments are brought in-house.

Regardless of what migration looks like, the sponsor can enjoy the best of both worlds using a hybrid approach to payments. They can expect rapid and accurate payments from their SaaS solution while strengthening their relationships with sites. And they can lean on the expertise and global reach of a strategic partner to address technical and compliance challenges while reducing risk and resource demands.

Jim DiCesare, Vice President, Financial Management Solutions, IQVIA Technologies, 

is passionate about delivering innovative cost benchmarking, CTA negotiation and site payment services that support clinical research conducted by sponsors and CROs. With more than 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now, IQVIA Technologies, Jim has expertise across the contracting, budgeting and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. He has a B.S. in Accounting from Kutztown University.

Bringing some payment activities in-house while outsourcing others can help sponsors optimize clinical trial efficiency, reduce risks, and strengthen site relationships.

Why Sponsors Should Consider a Hybrid Approach for Clinical Trial Payments 

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how real-time data access is helping biotechs accelerate trial timelines, ensure patient safety, and gain greater oversight—especially through integrated CDMO and CRO partnerships.

Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials

, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: Why has data visibility become such a critical driver of efficiency and oversight in modern clinical trials, especially for biotechs?

I think for biotechs, typically what we're seeing now—and probably now, more than ever—is they have fantastic products that they've developed. They have very aggressive timelines, and they have budgets that they need to adhere to. The way that we think about data and how it enables biotech and enables the industry is, if you think about partnerships and multiple suppliers in the supply chain, the more data they can provide to the biotech, the more actionable data. It means that they can, live, make decisions that will help them accelerate their timelines, and conduct a successful clinical trial, but also keep the patient safe within the trial as well. At Thermo Fisher Scientific, the way we're addressing this is with our Accelerator™ Drug Development program, where we're combining CDMO and CRO services. That means you have consistency across the supply chain, and single data sources that we can provide to our biotech partners.

Focus on biotech: Harnessing FSP engagements to deliver on-time, on-budget

The FDA has increasingly issued guidelines and set expectations for industry to enroll clinically relevant and diverse trial populations.

 Prior to the enactment of legislation through the Food and Drug Omnibus Reform Act of 2022, there were no widespread mandates requiring representative enrollment in industry-sponsored studies. In fact, during a cross-sector clinical research meeting in 2011, representatives stated industry would take initiative and strive to improve the representativeness of clinical research without the need for regulatory mandates.

 It appears that many key players in the clinical trial ecosystem did exactly that—implementing policies and practices that directly or indirectly support more inclusive and representative clinical trials, such as:

 began requiring authors to report on disease background and study population representativeness—an approach now adopted by many journals.

 Launched in 2012, the FDA’s Patient-Focused Drug Development (PFDD) program introduced patient listening sessions and industry guidance for incorporating patient voice into medical product development.

 Although PFDD began in response to a congressional mandate under FDASIA, FDA remained committed to enhancing this initiative.

Guided by the PFDD framework, advocacy groups have led over 100 externally hosted patient listening sessions.

Companies such as Bristol Myers Squibb have set goals to conduct trials at sites located in racially and ethnically diverse metro areas to improve accessibility.

Federal policy on trial participation coverage.

 US policy now requires Medicare, all state Medicaid programs, and private insurers to cover routine care costs for trial participants.

Cross-sector partnership launches EQBMED.

 Initially funded by PhRMA and established as a cross-sector collaborative, Equitable Breakthroughs in Medicine Development (EQBMED) launched a pilot to develop an infrastructure of community-based trial sites.

 Many health systems have adopted diversity, equity, and inclusion (DEI) and health equity programs to better reflect and partner with their communities.

 The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has issued guidance and toolkits to promote representation in research across dimensions such as race, ethnicity, disability, LGBTQIA+ identity, and more.

Meanwhile, mandates for clinical trial diversity are beginning to take effect. Unless modified, the current legislation enacted under FDORA will soon require sponsors to submit diversity action plans (DAPs) to the FDA for all pivotal studies.

 Encouragingly, many sponsors have already begun submitting DAPs voluntarily ahead of these statutory requirements.

DAPs offer a valuable framework for proactively planning inclusive research across the development lifecycle and should be considered best practice—regardless of legal obligation. They can guide trial design, site selection and staff training, culturally tailored recruitment and retention strategies, and ongoing engagement.

We appear to be moving in the right direction toward sustainable change in clinical trial inclusivity—even in the absence of mandatory policies. According to various published reports, clinical trials supporting FDA approvals have shown progress in demographic diversity, with increased representation of women, older adults, and Black participants, and a decline in White overrepresentation—dropping below 75% by 2020.

However, representation remains inconsistent across studies, with some populations over- or underrepresented depending on the condition and benchmark used.

Despite ongoing variability in enrollment by demographic subgroup, progress is evident compared to 2011, when 83% of participants in domestic industry-funded trials were reportedly non-Hispanic White.

 However, much of the focus to date has been on demographic characteristics. At a 2024 National Academies of Sciences, Engineering, and Medicine workshop, FDA and NIH leaders acknowledged progress in racial, ethnic, and sex-based inclusion, but emphasized that representation remains lacking across a broader spectrum, including rural populations, older adults, Indigenous peoples, people with disabilities, and sexual and gender-diverse individuals.

In January 2025, new disruptions emerged with the administration’s executive orders and efficiency measures—banning DEI initiatives, threatening investigations into “illegal DEI practices” in the private sector, significantly cutting funding for research grants, and eliminating or downsizing several Health and Human Services divisions focused on addressing health disparities.

Staffing and policy changes at the FDA, along with efforts to lower prescription drug costs, have prompted some biotech companies to move early-stage trials overseas and may discourage investment in innovation and additional indications—leading to fewer opportunities to offer clinical research as a care option.

 Collectively, these shifts threaten to erode progress in inclusive research—reducing investments in innovation, narrowing patient access, and weakening the infrastructure needed to sustain equitable participation—and, more broadly, pose risks to clinical development that depend on diverse participation for real-world relevance.

These are not the policies the clinical trial ecosystem had hoped for.

While policy should support rather than hinder progress, the question remains whether mandates are truly effective. Although the NIH has required the inclusion of women and members of diverse groups and their subpopulations—distinguished by racial, ethnic, or cultural heritage—in NIH-funded clinical research since the 1993 Revitalization Act, many researchers fall short in planning how to meet these goals.

Many NIH-funded principal investigators do not establish recruitment goals for all demographic subgroups, suggesting a lack of intentional planning. In one study, published in 

, fewer than 3% of National Heart, Lung, and Blood Institute-funded researchers set goals for all demographic groups and were more likely to miss goals for Black (51%), Asian (55%), and Hispanic (44%) participants than for White participants (30%). In a related study, published in 

, only 36% required cultural competency training for site staff, despite recommending it as a best practice.

The implications are clear: disparities in trial participation persist in NIH-funded research. Participant demographics vary widely across NIH institutes and centers, with Hispanic individuals appearing to be the most underrepresented.

 Trends from National Cancer Institute trials between 2005 and 2020 show lower participation by older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic individuals compared with their representation in the US cancer population.

NIH initiatives, however, demonstrate how accountability can drive inclusive research practices. For example, to maintain federal designation, Alzheimer’s disease research centers must engage in ongoing community education—reaching diverse populations, including non-English speakers.

Community-building efforts such as those from EQBMED and other sponsor—or site-led initiatives—are expanding but more efforts are needed. Sponsors and CROs could adopt a points-based system for site efforts and allocate resources to support site-level community engagement. NIH also requires institutional review boards to consider both its inclusion policy and the FDA’s (now-withdrawn) guidance on evaluating gender differences in drug research.

Amid uncertain regulatory expectations, many leading organizations are setting the standard by integrating inclusive practices into their trial operations. To drive meaningful and measurable impact, these efforts must become standard, consistently applied, and reinforced through clear accountability across the research ecosystem.

, PhD, is a clinical research recruitment and inclusion executive and strategist. In her most recent role, Johnson led the clinical trial recruitment and diversity, equity, and inclusion functions at SPARC. Prior to that, she held several leadership positions within IQVIA’s patient recruitment team, including advising pharmaceutical sponsor teams with their efforts to achieve more diverse trial populations. Johnson has a Master’s in Public Health and a PhD in Health Sciences. Her doctoral dissertation research focused on increasing access to clinical trials for historically underrepresented populations.

The evolution of US FDA diversity requirements in clinical research. 

https://globalforum.diaglobal.org/issue/december-2023/the-evolution-of-us-fda-diversity-requirements-in-clinical-research-2/

2. Coakley, M., Fadiran, E., Parrish, L., Griffith, R., Weiss, E., & Carter, C. (2012). Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trials. 

3. The Editors. (2021, September 13). Striving for diversity in research studies. 

4. United States Department of Health and Human Services (USHHS), Food and Drug Administration (2025, March 21). 

FDA-led patient focused drug development (PFDD) public meetings

https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings

5. United States Department of Health and Human Services (USHHS), Food and Drug Administration (2025, March 21). 

FDA patient-focused drug development guidance series for enhancing the incorporation of the patient’s voice in medical product development and regulatory decision making

https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical

6. Food and Drug Administration Safety and Innovation Act, Public Law No 112-144, S. 3187, 21 U.S.C. 301 

Patient centricity in the biopharmaceutical industry: Are we nearly there yet? A collection of perspectives from researchers, approvers, and patients. 

8. Bristol Myers Squibb. (2024, August 1). 

Diversity in clinical trials is a scientific imperative

https://www.bms.com/media/media-library/scientific-media-resources/importance-of-clinical-trials-and-role-of-diversity.html

Medicaid coverage of “routine costs” for clinical trials

https://www.appliedclinicaltrialsonline.com/view/medicaid-coverage-of-routine-costs-for-clinical-trials

https://www.govtrack.us/congress/bills/116/s4742/text

11. Equitable Breakthroughs in Medicine Development (EQBMED). (2024, September 12). 

Equitable breakthroughs in medicine development (EQBMED) to work with inaugural sponsor companies to drive greater diversity in clinical trials

https://www.prnewswire.com/news-releases/equitable-breakthroughs-in-medicine-development-eqbmed-to-work-with-inaugural-sponsor-companies-to-drive-greater-diversity-in-clinical-trials-302246462.html

Anti-‘woke’ backlash forces health industry to adapt DEI efforts. 

https://www.modernhealthcare.com/hospital-systems/healthcare-dei-anti-woke-law-ron-desantis-trinity-health

CommonSpirit to expand DEI programs despite federal pushback. 

https://www.modernhealthcare.com/providers/commonspirit-dei-program-extensions-morehouse

14. The MRCT Center of Brigham and Women’s Hospital and Harvard. (2024). 

The MRCT Center of Brigham and Women’s Hospital and Harvard.

https://dev.mrctcenter.org/project/representation-in-research/

15. Food and Drug Administration. (2024, June). Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies: Guidance for industry. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies

16. National Academies of Sciences, Engineering, and Medicine. (2024).

 Toward a framework to improve diversity and inclusion in clinical trials: Proceedings of a workshop (2024)

. Washington, DC: The National Academies Press. 

17. National Academies of Sciences, Engineering, and Medicine. (2022).

 Improving representation in clinical trials and research: Building research equity for women and underrepresented groups

18. Getz, K., Smith, Z., & Peña, Y. (2020). Quantifying patient subpopulation disparities in new drugs and biologics approved between 2007 and 2017. 

Advancing more inclusive and representative clinical trials through action and accountability.

Eric D. Peterson, MD

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