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Partnership formation is the new trend in common technical document development.

Common Technical Document Development

Zach Bader (Vice President, Business Development) talked with 

 about  how Dr. Vince Clinical Research (DVCR) is changing the CRO industry.

How their new facility aides recruitment retention

Their commitment to delivering quality data faster

What a physician-run, physician-led CRO looks like

DVCR

 ’Accelerating Clinical & Drug Development Timelines with AI’

? The recording is now available—discover how AI is transforming drug discovery now with industry leaders from Dr. Vince Clinical Research, Enveda Biosciences, and Clario. 

DVCR would like to serve as Your Full-Service CRO™. Explore how our team of experienced early clinical development professionals can support your research needs in our 

DVCR is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas. 

 for an overview of our world-class clinical pharmacology unit and CRO services.

DVCR is Designed Differently

Korey Nevitt (Executive Director, Site Partnerships) talked with 

 about what makes Dr. Vince Clinical Research (DVCR) solutions for clinical pharmacology and multi-site studies unique.

Their focus on quality and customer service

Their lead site model and its support for sponsors

How they anticipate and manage problems for multi-site trials from start to finish

DVCR's Multi-Site Model

 about how PCM Trials are harmonizing various elements in the decentralized clinical trial process.

The benefits of home visits in decentralized clinical trials

What to look for in a home visit vendor for a successful study

How home visits and community research sites have been misunderstood

PCM Trials

Jon Ernst (Vice President, In-Home Solutions, Decentralized Clinical Trials) discusses today's clinical trial landscape. 

Reducing Patient Dropout Rates and Accelerating Trial Completion

The evolving regulatory landscape in clinical research was an important topic covered at the 2024 Veeva R&D and Quality Summit. As the complexity of trials grow, regulatory agencies are enforcing greater oversight to ensure they remain compliant. At the Summit, 

 caught up with Dee DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) to discuss the current regulatory landscape as well as her own experience with managing regulatory operations.

ACT: Could you tell us a little about Cerevel and your role?

 First of all, Cerevel was very recently acquired by AbbVie. I now work for AbbVie. Cerevel was a small pharmaceutical company established in 2019 seeking to transform lives of patients with neuroscience diseases.

At Cerevel, I was head of global regulatory operations. I was hired in early 2020 to establish the regulatory operations function. I built and provided oversight of the team that manages regulatory submission logistics, including publishing and we also administered all regulatory systems such as Veeva Vault RIM.

ACT: At Cerevel, you’ve built the regulatory operations function from the ground up. What was your vision for regulatory operations and the strategy to make it a reality?

 Given Cerevel was a small company, my vision was to create a full service global regulatory operations function that was fit for purpose. In a startup environment, you have individuals wearing many hats and things happening quickly. This required regulatory operations to be a nimble, focused function at Cerevel. Our key to on-time quality submissions was early engagement, frequent touchpoints, having a focus on quality by building QC steps along the way, and aiming to optimize logistics to allow submission teams to focus on the science.

The regulatory operations team consisted of internal individuals and an external publishing vendor. There is a lot of ways to do this, but at Cerevel the vendor was used strategically to optimize budget spend and allow us to get submissions out the door as quickly as possible. To do that we did submission/content plan management and document-level publishing in-house while utilizing the external vendor predominantly for the eCTD submission build.

ACT: Cerevel enabled site, product, and clinical study data to flow between the clinical and regulatory vaults. What are the benefits of establishing this connection between clinical and regulatory?

 Cerevel was early adopters of Veeva’s Regulatory to Clinical Connector, which allows both documents and data to be transferred between the regulatory and clinical vaults.

An industry pain point is the redundant work that is required due to the overlap of documents within the eTMF and RIM systems. You also have more than one person making duplicate uploads or entering identical information which could led to misalignment. The biggest benefit is we didn’t have people doing the same thing twice, this eliminated redundancy, ensured consistency, and maintained a single source of truth.

 is focused on regulatory, so this question will help our readers. As clinical trial complexity grows, regulatory agencies require more data and proof products are effective. We want to tap into your robust experience in regulatory operations. What advice would you give to companies looking to remain compliant while executing complex clinical trials?

 As clinical trials become more complex, a well-structured defined submission process is key. However, it’s crucial to strike the right balance, you still want to be able to do things efficiently and quickly. In my opinion, a centralized approach to managing CTAs can be extremely helpful. For example, having a dedicated regulatory operations resource who can guide the team through the process and ensure compliance can be a game changer. For example, for EU CTR, training was crucial to getting everyone on the same page cross functionally, and regulatory operations was involved to not only to provide CTIS portal administration but also the guardrails to ensure compliance with proper document handoffs and approvals.

ACT: Looking ahead, where do you see regulatory operations advancing over the next five years?

As we move forward, I anticipate regulatory operations will continue to evolve towards a more technical and strategic role. Rather than administrative, the regulatory operations professionals should be seen as technical experts, data governors, and systems and process builders.

Technology will play a crucial role in this transformation. Automation can help streamline processes, reduce manual tasks, and improve efficiency. For example, I see the potential to delegate repetitive tasks to AI and focus on more strategic work that requires human expertise.

Additionally, data governance will become more important as we move away from document summaries towards data driven submissions.

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators. 

Latest Conference Coverage

2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliveira

Since 2016, the FDA has released various guidance documents intended to promote diversity in clinical trials—particularly regarding recruitment of trial participants—and the agency’s diversity commitments are only expected to grow. As such, entities sponsoring and designing clinical trials must be proactive in ensuring that protocol inclusion and exclusion criteria do not inadvertently exclude diverse populations (absent scientific justifications). 

Moreover, as technology advancements continue to reshape the clinical trial landscape, entities should increasingly explore the use of decentralized trial models, telemedicine, and remote technology for extended outreach and inclusion of diverse populations. This article thus highlights the key takeaways of several FDA diversity-related guidance documents from 2016 onwards; outlines the potential for decentralized models and digital health technology to expand diversity in trials; and informs sponsors on the need to be aware of future guidance documents that will be released over the coming years.

Individuals within in the United States differ by sex, age, race, ethnicity, location, economics, and many other characteristics, while different groups within these populations may respond to medications in different ways. For these reasons, the FDA recognizes that it is important that clinical trial inclusion criteria (explained in greater detail below) seeks representatives of the different groups who will use these medications to provide data on the safety and efficacy for these diverse groups.

The FDA’s commitment to increasing diversity in clinical trials is clear and evidenced by guidance it issued within the past decade. Indeed, since October 2016, the FDA has released various guidance documents intended to promote and increase diversity in clinical trials, and with a focus on the recruitment of diverse clinical trial participants.

The focus of the FDA’s diversity efforts is often on clinical trial participant eligibility criteria. In conducting a clinical trial, a sponsor must determine which individuals are “eligible” to participate, while determinations as to eligibility criteria are generally based on the purpose and type of the clinical trial to be performed and the investigational product. The exclusion of certain populations from a trial is often an unintended consequence of setting eligibility criteria, without scientific justification. Accordingly, FDA guidance over the years includes a focus on how to increase participant diversity.

October 2016 - Collection of Race and Ethnicity Data in Clinical Trials Guidance

In 2016, then FDA Commissioner, Robert Califf, MD, declared that 2016 was the “Year of Clinical Trials Diversity” and in October of that year, the FDA issued a guidance outlining expectations and recommendations regarding the standardized approach for collection and reporting of race and ethnicity data in clinical trials. The October 2016 guidance document, “Collection of Race and Ethnicity Data in Clinical Trials Guidance for Industry and Food and Drug Administration Staff,”

 was issued in response to the Office of Management and Budget (OMB) Statistical Policy Directive 15, Revisions to the Standards for the Classification of Federal data on Race and Ethnicity. The guidance set forth FDA expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials.

Further, the 2016 guidance lists the OMB categories for race and ethnicity and describes FDA's reasons for recommending the use of the categories in medical product (drugs, biologics, and devices) applications. As later discussed herein, the FDA reaffirmed its commitment to diversity and inclusion, and with respect to standards for the collection and reporting of race and ethnicity data via a 2024 draft guidance, which is intended to replace the 2016 guidance.

November 2020 - Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs

Continuing its focus on diversity in clinical trials, in November 2020, the FDA issued a guidance document titled, “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs,”

 which focuses on sponsors and provides four sets of recommendations that can be applied in clinical trial design to ensure participants are diverse.

In issuing the guidance, the FDA satisfied the mandate under section 610(a)(3) of the FDA Reauthorization Act of 2017 (FDARA) (21 U.S.C. 360bbb note). Consistent with the FDARA mandate, the guidance discusses: (1) broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials; (2) developing eligibility criteria and improving trial recruitment so that the participants enrolled in trials will better reflect the population most likely to use the drug if it is approved, while maintaining safety and efficacy standards; and (3) applying the recommendations for broadening eligibility criteria to clinical trials of drugs intended to treat rare diseases or conditions. The guidance also notes that sponsors should design clinical trials in ways to achieve participant diversity.

Examples of FDA recommendations to sponsors on how to improve diversity include:

Sponsors should work to ensure that eligibility criteria serve the goal of having a representative sample of the population for whom the drug has been developed and examine each exclusion criterion to determine whether it is needed to help assure the safety of trial participants or to achieve the study objectives.

Sponsors should enroll participants who reflect the characteristics of clinically relevant populations with regard to age, sex, race, and ethnicity and can seek to do so via (1) inclusion of children and adolescents in confirmatory clinical trials involving adults when appropriate, (2) inclusion of women in adequate numbers to allow for analysis by sex, and (3) inclusion of racial and ethnic minorities and the analysis of clinical trial data by race and ethnicity.

Broadening eligibility criteria using enrichment strategies

 and should work to make trial participation less burdensome for participants. The FDA highlights use of telemedicine in trials and states: “During the study design phase, consider the recruitment challenges that may occur because of the planned visit schedule and difficulties with accessibility (including for individuals with disabilities) to trial sites: reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy, and consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or digital health technology tools can be used to replace site visits and provide investigators with adequate real-time data. Consider the use of mobile medical professionals, such as nurses and phlebotomists, to visit participants at their locations instead of requiring participants to visit distant clinical trial sites.”

Adopt enrollment and retention practices that enhance inclusiveness. Sponsors should implement more inclusive strategies for public outreach and education, including incorporating patient-focused research into clinical trial design.

April 2022 - Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials

Following the November 2020 guidance, in April 2022, the FDA released the draft guidance titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry.”

 The guidance recommends sponsors develop a Race and Ethnicity Diversity Plan to assist in enrolling underrepresented racial and ethnic populations in clinical trials.

Specifically, the draft guidance expands on the 2016 guidance and provides recommendations to sponsors on the approach for developing a Race and Ethnicity Diversity Plan “to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.”

The draft guidance contains a table with suggested elements of a diversity plan and outlines the content of such plans, which includes:

Sponsors should define enrollment goals for underrepresented racial and ethnic participants as early as practicable.

The plan should describe the planned assessment of race and ethnicity.

The plan should outline the sponsor’s plan to collect data to explore the potential for differences in safety and/or effectiveness associated with race and ethnicity throughout the entire development life cycle of the medical product and not just during the pivotal trial(s) or studies.

Many of the recommendations in the April 2022 draft guidance are identical to the requirements set forth in the FDORA. At the end of 2022, as part of the Consolidated Appropriations Act, Congress passed the FDORA, which requires sponsors to submit diversity action plans to the Secretary of the Department of Health and Human Services (HHS) for any Phase III or other pivotal drug study and most device studies.

The requirement for diversity plans in the FDORA include identifying enrollment goals for subsets of the population by group, sex, racial and ethnic characteristics, rationale for these enrollment goals, and any relevant strategies on how the sponsor plans on how to reach those enrollment goals. Pursuant to FDORA, the FDA must issue updated draft guidance on Diversity Action Plans.

Recent FDA Guidance and Action – January 2024 Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

In January 2024, the FDA released the draft guidance document “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products Guidance for Industry.”

 The guidance was mandated as part of FDORA regarding the collection of race and ethnicity data in clinical trials. Once finalized, this guidance will replace the 2016 FDA guidance regarding collection of race and ethnicity data.

The guidance provides that using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to the FDA. The agency’s recommended approach is based on the OMB Statistical Policy Directive No. 15 (Policy Directive 15) and was developed in accordance with section 4302 of the Affordable Care Act; HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status; and the 25 Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan.

The draft guidance provides recommendations on: (1) meeting the requirements set forth in the 1998 final rule regarding presentation of demographic data in investigational new drug applications and new drug applications; (2) the collection of race and ethnicity data in biologics license applications and medical device applications; and (3) addressing the FDASIA Section 907 Action Plan to improve the completeness and quality of demographic data collection and reporting.

The FDA recommends that trial participants be requested to self-report race and ethnicity information, with participants being permitted to designate a multiracial identity. While such data may be available in a trial participant’s medical record, the FDA states that race and ethnicity should not be assigned by the study team conducting the trial and recommends that investigators and/or other clinical study staff verify the accuracy of the information provided in the medical record with the study participant.

With respect to participant self-reporting, similar to the 2016 guidance and to remain consistent with OMB Policy Directive 15, the FDA recommends using a two-question format for requesting race and ethnicity information, with the ethnicity question preceding the question about race:

1. Are you Hispanic/Latino or not Hispanic/Latino?

With respect to race, the FDA recommends the following, minimum, choices be offered: American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White.

 The FDA also encourages sponsors to provide detailed breakdowns when multiple responses are selected or at a minimum to note that “more than one race” was reported. Where appropriate, the FDA recommends using more-detailed categories by geographic region to provide sponsors flexibility in characterizing race and ethnicity.

Moving Forward: The Use of Decentralized Clinical Trials (DCTs) and Digital Health Technology

As the emphasis on encouraging diverse populations to participate in clinical trials increases, sponsors should use all tools available to them to help increase diverse recruitment. One such tool is the use of DCTs (either a wholly or partially decentralized model) for sponsors to help fulfill these obligations. In May 2023, the FDA released the draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders”

DCTs are clinical trials in which some or all trial-related activities occur at locations other than traditional clinical trial sites. In the 2023 DCT guidance, FDA recognizes that use of decentralized elements, such as conducting follow-up visits in a participant’s home or via telemedicine, increases the convenience of such activities for research participants and can assist in diversity efforts.

A key element in the draft guidance centers around sponsor responsibilities for striving toward diversity and inclusiveness in their trial populations. The guidance specifies that sponsors engaging in outreach through local health care institutions may facilitate recruitment of participants in areas where there are limited or no traditional clinical trial sites that may increase diversity. 

The focus on diversity is highlighted by a press release announcing the guidance, which specifically highlights the value of DCTs in regard to enhancing diversity. In the release, Commissioner Califf stated:

"As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility."

Additionally, in the design of clinical trials, including DCTs, sponsors should consider the incorporation and use of digital health/telemedicine technologies in trials. The FDA has provided guidance on use of such technologies in clinical trials and notes their usefulness in reaching diverse populations previously not easily accessible.

Looking Ahead: What Sponsors Need to Know

Sponsors should be aware that the FDA’s focus on expanding diversity in clinical trials will not disappear any time soon. Instead, we expect the FDA’s focus on the issue to only intensify.

As a result, we recommend sponsors do their best to comply with FDA recommendations outlined in this article and in the FDA’s guidance documents. Even though the recent FDA documents are purely draft documents, sponsors should aim to comply with these recommendations so they are better prepared to comply with the final guidance when it is released.

Finally, sponsors should be aware that additional final guidance is likely to be announced over the next few years, including final guidance regarding diversity action plans. Sponsors must be ready to quickly implement these recommendations.

1. See FDA Guidance Document “Collection of Race and Ethnicity Data in Clinical Trials Guidance for Industry and Food and Drug Administration Staff “ October 2016”; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials

2. See FDA Guidance Document “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” November 2020; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

3. Enrichment is a trial design strategy in which there is a targeted inclusion of certain populations, with the goal of more readily demonstrating the effect, if any, of the drug. See Id.

5. See FDA draft Guidance “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry” April 2020; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

8. See FDA draft Guidance “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products Guidance for Industry” January 2024; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials-and-clinical-studies-fda-regulated-medical

13. See FDA draft Guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders” May 2023; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices

14. See FDA Guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” December 2023; 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations

; See FDA Digital Health Technologies (DHTs) for Drug Development, 

There is significant potential in decentralized models and digital health technology to expand diversity in clinical trials.

An Overview of FDA Diversity-Related Documents for Clinical Trials

Today, clinical trial data collection faces increased complexity due to data duplication between research systems and electronic health records (EHRs), particularly in oncology studies. Manual processes, such as data entry, consume significant time and resources. Over 50% of clinical trial data is duplicated between research systems and hospital EHRs, with around 20% of total study costs typically allocated to data duplication and verification.

The number of data points collected in oncology trials has surged dramatically over the past decade, driven by advances in genomic technologies, digital health tools, and personalized medicine. While this increase in data volume enhances our ability to understand and treat cancer more effectively, it also presents significant challenges in data management and analysis. In typical Phase III oncology trials, approximately 10,000 data points are collected per patient. However, in trials incorporating genomic and digital health data, this number can multiply ten to a hundredfold.

As a result, study sites, particularly clinical research coordinators (CRCs), face increased workloads, complex data management tasks, and the need for specialized training, leading to higher personnel costs. Sponsor companies incur additional expenses due to investments in advanced data management tools, extended trial timelines, and source data verification (SDV). To mitigate these challenges, sites and sponsors must explore innovative solutions, collaborate with stakeholders and vendors, and ensure regulatory compliance to improve efficiency, reduce costs, and enhance cancer treatment outcomes.

EHR to electronic data capture (EHR-to-EDC), or eSource technology and processes, offers a promising solution, delivering significant time and cost savings by streamlining data transfer.

The European EIT Health-supported EHR2EDC project estimated a total time of three minutes per data point in oncology trials, demonstrating substantial efficiency gains.

This paper presents a use case from Memorial Sloan Kettering Cancer Center (MSK), emphasizing the critical role of CRCs. It highlights the burdensome nature of current double-entry processes and supports the three-minute-per-data-point estimate. Additionally, it revisits the value generated for investigational sites and sponsors by introducing this technology, exploring the transformative potential of eSource for future clinical trials.

The study employs a qualitative structured interview guide to understand the data entry process during clinical trials. An in-depth, semi-structured interview was conducted with an experienced CRC to gather insights into workflows, challenges, and perceptions regarding data entry tasks. Open-ended questions allowed for rich, nuanced responses, capturing the complexity and variability of the process. The validity and generalizability of the interview outcomes were assessed and found to correspond well with CRC practices at MSK.

Gynet Santiago is a seasoned CRC at MSK, with 16 years of experience and involvement in over 50 clinical studies. She summarizes her role as, “I am responsible for collecting, extracting, and entering data for research projects, databases, and clinical trial protocols. This includes reviewing patient charts, existing databases, and other sources within a specific timeframe.”

The CRC is pivotal in executing clinical trials, with responsibilities spanning various trial phases to ensure compliance with regulatory requirements and ethical standards, while prioritizing patient safety and data integrity. During trial execution, CRCs manage participant recruitment, screening, and enrollment, ensuring informed consent is obtained. They accurately collect and document clinical data, monitor participants for adverse events, and ensure adherence to the trial protocol. CRCs act as liaisons between participants, investigators, and sponsors, maintaining communication and addressing issues. They also ensure regulatory compliance by maintaining accurate documentation and assisting with audits. These responsibilities are crucial for the smooth operation of trials, data integrity, and participant safety. Additionally, CRCs often manage multiple studies simultaneously, requiring efficient context switching throughout the week.

Navigating the complexities of EDC data entry

In clinical trials, EDC data entry is a multi-faceted process involving several crucial steps performed by a CRC (see Figure 1). This process, while systematic, is often challenging due to its time-consuming nature and the meticulous attention to detail required. 

The following is an overview of how a CRC manages the process of retrieving and manually entering data into an EDC system.

 One of the first tasks a CRC faces is finding and allocating time for EDC data entry. This often involves scheduling data entry activities around other demanding clinic responsibilities. For instance, a CRC might set aside Friday afternoons every two weeks for data entry once all other clinic activities have been addressed. Prioritizing EDC data entry among other tasks can be challenging, as the coordinator must balance immediate clinical duties with the time-consuming process of data entry. The irregularity and unpredictability of clinical activities can make it difficult to allocate consistent time slots for this purpose. Or as Santiago puts it, “Each day is based on what the priority is for that day, that’s how I know how to allocate my time. So, for example, if there’s a data lock coming up or an audit coming up for a particular study, that’s always going to be a top priority for me for that day or for that week.”

Patient information retrieval and manual searching for patient information. 

A use case by Memorial Sloan Kettering Cancer Center explores the potential of EHR-to-EDC.

Thomas Kalfas

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