Celebrating Clinical Trials Day 2023: Let’s Raise Awareness & Honor Research Professionals

May 20th marks Clinical Trials Day (CTD), an annual day of celebration and reflection for the clinical research community. This date commemorates the day in 1747 when James Lind launched the first-ever clinical trial, laying the foundation for modern clinical research. Since 2005, CTD has been celebrated internationally to raise awareness about the importance of clinical trials and honor clinical research professionals’ contributions.  

In this article, we’ll explore why it’s important to raise awareness about clinical trials and how we can honor the invaluable work of research professionals on this special day. In addition, we’ll explain why supporting and celebrating the people who dedicate their lives to improving public health through clinical research is more important than ever. So, let’s kick off the celebration of Clinical Trials Day 2023 together! 

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My Seat at the (Institutional Review Board) Table

Lauren Surden, MSW, CIP 

Sterling IRB 

I often get asked about the education and experience needed to be selected to serve on an Institutional Review Board (IRB).  The fallback response is that I hold a Master’s degree in Social Work (MSW), however, my education and work experience is only part of what I bring to my seat at the IRB table.  Understanding who makes up an IRB is important in understanding the ethical review process for clinical research. 

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Developing a Test Taking Plan when Pursuing Professional Certifications

Laura R. Holtz


Jessica Rowe


People pursue certifications for various reasons. Some pursue certification for professional credibility or recognition, while others aim to meet position requirements for job opportunities. “Certification demonstrates your commitment to superior professionalism, to upholding industry standards, and for continued learning (www.mbopartners.com).” Regardless of the motivation, all test takers want to be successful. In our respective roles, we are often approached by research professionals with questions about certification and about taking a certification exam. We rely on our backgrounds to construct a reply. Laura Holtz has a background as a teacher and as a project manager. She relies on her experience in those roles to provide guidance regarding certification. Jessica Rowe has a background in academia and in instructing adult students enrolled in graduate courses. She calls upon that experience to provide tips and tools for successfully pursuing professional certification. Of course, both authors rely on their own experiences pursuing their certifications when answering related questions.

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A “WIN” for FDA’s ORA Women Investigators

In Interview with

Andrace De Yampert, MS

This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment or sweeping organizational changes, every effort helps pave the way for a brighter future for all.  

In the spirit of empowering women in clinical research, this post will introduce you to the Women’s Investigator Network (WIN) and the women behind it. This distinctive program at the Food & Drug Administration (FDA) Office of Regulatory Affairs (ORA) supports women serving as ORA investigators by providing opportunities for professional development, leadership training, and personal empowerment. With more than 300 members and growing, WIN is a shining example of how organizations can foster a culture of inclusivity and diversity within the clinical research community. 

In honor of WIN’s second anniversary, we caught up with Andrace De Yampert, FDA ORA Office of Bioresearch Monitoring Operations (OBIMO) Program Expert and WIN Vice Chair, to learn more about her, the network, and its impact on women investigators at the FDA.  

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10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference

Angie Rock


Kathi Durdon


Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices – so she created one.

“My initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,” said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi’s vision, and the Annual Device Research & Regulatory Conference was born.

“Thanks to SOCRA’s support, I could create a different kind of conference – one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas – not just one or two areas,” Kathi recalled.

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it’s still the medical device research “go to” conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi’s tenure, to discuss the importance of the program, and to discuss future plans for the conference.

“This conference is Kathi’s brainchild. I’m honored to be a part of this phenomenal program – it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,” said Angie.

In this post, we’ll outline Kathi and Angie’s top ten reasons to attend this annual conference and why it’s important for device newbies and experts alike.

Top 10 Reasons to attend the annual Device Research & Regulatory Conference in 2023

1. It was created by device professionals for device professionals

As a device professional, Kathi designed the Device Research & Regulatory Conference to provide industry professionals with the tools, knowledge, information, and connections to succeed in their careers. Attendees should expect content and discussions that are offered on a range of relevant topics, including regulatory compliance, innovation and device development, and requirements for clinical investigations.

2. You will learn how to navigate the regulatory landscape

Angie pointed out that medical device research is drastically different from pharmaceutical research, in part, due to the complexity of regulatory pathways in bringing devices to market in the U.S. With so many intricacies and gray areas in the regulatory landscape, Angie believes that it’s critical to learn how to navigate the varying pathways. “I know that when I started, I had very little knowledge regarding the regulatory issues and opportunities, and this conference helped to provide a framework for navigating them,” said Angie.

3. Fantastic keynote speakers on hot topics

In keeping with Kathi’s vision for dynamic keynote and conference speakers discussing hot topics, this year’s speaker schedule is brimming with notable industry leaders and must-see presentations, including:

· Device Regulations & Classifications –

Angie Rock, MBA, CCRP, Director, Clinical Operations, BIOTRONIK, Inc., and Kathi Durdon, MA, CCRP, Executive Director, CNY Biotech Accelerator

· Overview of Premarket Submissions

Donna Headlee, RN, BSN, CCRP

· Devices, Decentralized Research, and Quality by Design – 3 Pillars to Success

Brian Barnes, MA, Senior Director, Product Development, Medidata Solutions

· FDA’s Digital Health Centers of Excellence Program (DHCoE) Overview of Resources

Glenda Guest, CCRA, RQAP-GCP, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training

· Career Planning: Acquiring Competencies & Champions

Erika Stevens, MA, FACRP, Principal Consultant, Recherche Transformation Rapide, Faculty Lecturer, Rutgers University

· GDPR and Other Regulatory Frameworks

Carl Carpenter, CEO, Arrakis Consulting

· Breakthrough Devices Program and Safer Technologies Program (STEP)

Donna Headlee, RN, BSN, CCRP

· The Ethics and Regulation of Medical Device Innovation

Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University

· Increasing Female and Minority Enrollment in Clinical Studies

Karlene Cox, BS, CCRP, CRA Manager, BIOTRONIK

· Imagining Failures to Identify Blind Spots in Device Research

David Staley, MA, Associate Director, Advarra’s Institutional Research Center of Excellence

· What to Know About the Proposed Rule to Harmonize the FDA Regulations on Human Subjects Research with the Common Rule

David Peloquin, JD, Partner, Ropes & Gray, LLP

· Updates to the FDA Inspectional Guidance Documents

Brandy Chittester, MS, Executive Vice President and Chief Strategy Officer, M&B Sciences, Inc.

· The Challenges of Subject Enrollment and Retention in a Longitudinal Study

Scott L. Wehage, MS, CCRP, Director, Clinical and Rural Health, St. Lawrence Health

4. Discover industry trends and how to put them into practice

This conference provides a unique opportunity to discover the latest medical device research trends and offers expert predictions for the industry’s future. Kathi and Angie hope that attendees will walk away with a greater understanding of industry trends and practical ways to incorporate them into their daily practice.

5. Connect and network with other device professionals

One of Kathi’s primary goals when creating this program was to offer an opportunity to connect and collaborate. So, expect plenty of opportunities to network with fellow medical device professionals at this 2-1/2 day conference. If you want to make the most of your experience, check out these helpful tips for networking at scientific conferences.

6. Share your knowledge and get advice

The Device Research & Regulatory Conference allows ample opportunity to share knowledge through interactive presentations and Q&A sessions. “If we didn’t hit on a topic an attendee is interested in, we invite them to share that topic with the group so that we can work together to solve a problem, find resources, or offer suggestions,” said Kathi. Angie added, “I love working with teams and mentoring individuals, and the device conference is a great platform for sharing education and experience with people seeking advice.”

7. Discover career development opportunities

This conference offers plenty of educational sessions and opportunities to connect and network with “movers and shakers” in the medical device industry, making it an excellent forum to also explore career development opportunities. Whether you’re looking to upskill, discover new opportunities, or find a mentor, the Device Research & Regulatory Conference has it all. You will also earn CME, CNE and SOCRA continuing education credit hours by attending the conference and the optional Device Basics preconference workshop.

8. It’s a valuable resource for startups and for those new to device research

With Kathi’s background and experience in helping medical device startups navigate the process of bringing safe and effective devices to market, she passionately encourages device innovators to attend this conference. “I love my job because I get to work with students, faculty members, and small company representatives with ideas for new devices in responses to unmet needs,” she said. “Some of the proposed technologies blow my mind! However, it can be a daunting task when you’re unsure which development path is potentially the most effective, especially on a limited budget. That’s where I and the incredible resources at this conference come in. We’re here to help big ideas succeed because innovation is essential for economic development.”

9. There will be something for everyone

The Device Research & Regulatory Conference is geared for attendees with a range of roles and responsibilities, including:

· Clinical Research Professionals (e.g., Clinical Investigators, Clinical Research Associates, Clinical Research Coordinators, Program Managers, etc.)

· Government, University/Academic, Industry, and Support Organization Representatives

· Quality, Regulatory, Research and Development, Engineering, and Human Factors professionals

· Medical Device Designers/Developers

· Medical Device Startup Companies

· Medical Device Vendors and Service Providers

· Contract Research Organization (CRO) specialists

· All others interested in learning more about medical device research and the medical device development regulatory process

Angie Rock noted that the conference is great for new and experienced research professionals alike, “Everyone will leave the conference with new information and additions to their professional network.” and “Our audience’s backgrounds are an even mix of site-oriented and sponsor-related professionals, giving attendees many opportunities to talk to other researchers about their “pain points,” and how they can work together for a better outcome.

10. Help advance the release of new device technologies

Finally, the Device Research & Regulatory Conference offers a place to learn and connect as we work toward a universal goal: to release safe and effective medical technologies to the market. “What motivates me every day is to help drive development so that clinicians are more efficient in their diagnoses and treatments and patients can experience improved outcomes,” said Angie. “This conference allows you to connect with a diverse group of people to help you to address and satisfy the high level of compliance requirements and scientific rigor that will ensure the safety of all research participants, as we work toward releasing safe and effective devices.

To learn more about the 16th Annual Device Research & Regulatory Conference or register for this premier conference for medical device professionals visit the links above or email us at office@socra.org.

Medicare Coverage Analysis – A Billing Compliance Perspectives

Sachit Verma, MD, MBA, FAPCR

Medicare Coverage Analysis (MCA) is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third-party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors.

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Leveraging eSource as a Study Manager for Remote Monitoring 

By:  Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero


I have long been a proponent of the potential of eSource and its advantages in clinical trials.  From my experience as a CRA (Clinical Research Associate) I first wrote about eSource in Nov 2018 SOCRA and Jan 2019 ACRP which enabled me to see that clinical research was only just scratching the surface on leveraging eSource to fundamentally change the way we are monitoring clinical trials.  At the time I did not expect to be find myself in a position to make a meaningful shift towards remote monitoring.  Several years later while working as a CTM (Clinical Team Manager) COVID forced CROs (Contract Research Organizations) to rethink their monitoring paradigm.  Drawing from both my own and my team’s experience with eSource, our study was able to successfully implement a remote monitoring process to mitigate the issues of running a clinical trial during a pandemic.  Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.   

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SOCRA 2022 Year in Review & What to Expect in 2023

As 2022 draws to a close, we’re proud to recognize the year’s activities, accomplishments, and progress as we prepare to welcome the New Year ahead. We invite you to join us in reflecting on 2022 and looking ahead to what you can expect in 2023.

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31st SOCRA Annual Conference Wrap-Up

We proudly hosted the 31st Annual Conference from September 14-17, 2022, gathering our global clinical research community virtually in an engaging learning and networking environment. This year’s event was brimming with more experts, content, networking and learning opportunities as part of our commitment to offer new ways to learn, grow, and connect with other clinical research professionals.

We were thrilled with this year’s attendance and energy as we shared ideas to promote safe, efficient, and high-quality clinical research. We also hosted award presentations recognizing our members’ steadfast dedication to advancing this ever-evolving field.

In case you missed this year’s conference, we’ve summarized the event in this wrap-up post featuring conference highlights, themes, and special recognition award winners.  Also, as a benefit to our broader clinical research community, plenary session recordings from this conference (and past conferences) are available on our website here.

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Leadership and Line Management in Clinical Research

Anatoly Gorkun
Senior Manager, Global Clinical Management, PPD
Hugh Devine
Senior Director, Global Clinical Management, PPD

Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and its workforce to deliver company objectives. This article provides an overview of line management styles and line-management-through-leadership approaches in the clinical research environment. The line management cycle – team building, support, motivation, and development—is described. Real-life examples illustrate how line management can support clinical research deliverables.

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