Ask the Advisor

An internationally recognized TMF subject matter expert with 15+ years of experience in the clinical research industry. Sholeh is Founder and Principal Advisor at CRG Advisors, a boutique clinical research advisory firm specializing in Quality, Regulatory, and TMF (QRT) consulting services. CRG partners with sponsors and CROs to strengthen inspection readiness, improve operational quality, and optimize Trial Master File health through practical, experienced support. Services include quality assurance and quality systems, inspection readiness, regulatory support and compliance, TMF management and remediation, SOP development and process optimization, TMF health checks and oversight, CAPA management, and clinical operations support.

quality. regulatory. tmf. done right.

Kunal Sampat, MNA, ACRP-CP, RAC, is the founder of Trial Forward, a clinical operations advisory and execution company supporting MedTech sponsors. With more than 20 years of experience in clinical research, Kunal has led and supported global medical device clinical trials across clinical strategy, study execution, site engagement, enrollment, and operational delivery. He is also the creator and host of the Clinical Trial Podcast, an educational platform featuring conversations with leaders shaping the future of clinical research. In addition to his industry work, Kunal is actively involved with San Jose State University’s Biotechnology program, where he helps develop and mentor the next generation of clinical research professionals.

Gokhul Srinivasan partners with the founders and technology leaders of healthcare and life sciences startups, from clinical research to genomics, turning agentic AI into trusted products and businesses that scale. As a Senior Partner Solutions Architect in the AWS Global Startup Program, he steers them through the three strategic decisions that determine growth: how to build a solution on AWS that meets the governance bar of a regulated industry, how to take it to market with AWS, and how to fund the path from pilot to production. At Research Revolution 2026, Gokhul joins Florence CTO Andres Garcia for “AI & MCP 101: A Primer on the New Age of Data Fluency with AI.” He is based in Raleigh, in the heart of North Carolina’s Research Triangle.

Eric serves as the Clinical Research Solution Leader for Huron. He has a proven track record spanning 26 years, serving academic medical centers, community health systems, cancer centers and free-standing research institutes. During that time, Eric has worked across the research spectrum, focusing on strategy, governance, operations, compliance, and technology assessment and implementation. Eric’s areas of professional interest include aligning clinical, education and research missions, addressing research health disparities, technology enablement and data maturity. He has led strategic research growth initiatives with top research universities, designed and implemented multiple research operating models and Clinical Trial Offices, and deployed SaaS-based CRM technology solutions across universities, academic medical centers, community and children’s hospitals, cancer centers, and research institutes.

A registered nurse with more than 40 years of experience, she heads a nationally respected firm specializing in clinical research and healthcare compliance. She serves on the faculty of the HCCA Academies for the Healthcare Compliance Association and the Society of Corporate Compliance and Ethics (HCCA/SCCE). In 2019, she was appointed by the Governor of South Carolina to the state’s Small Business Regulatory Review Committee. In 2026, she was appointed to the CDC’s National Committee for Vital Health Statistics. Since 2017, Kelly has been an active advocate for hands-free legislation at both the state and national levels, a commitment shaped by the tragic loss of her husband in a hit-and-run cycling accident. Hands-free legislation was passed in South Carolina in September of 2025, much of it due to Kelly’s advocacy. In partnership with Prisma Health’s Upstate Foundation and Prisma Healthcare Midlands Foundation, she established the Dale A. Willenberg Congenital Heart Disease Endowment, which supports Camp Heart to Heart in the Upstate and the Norton Family Point of Care Ultrasound Program in the Midlands. Kelly is also an accomplished author, podcaster, and national speaker and a graduate of The Campaign School at Yale and Healing Politics.

Jeff Smith is co-founder of the Innovation Network and the Whale Tank, platforms that help life science leaders discover and collaborate on emerging solutions. He co-founded Tryl, which won a SCOPE trophy and announced its acquisition during the SCOPE Summit. Like many in the field, Jeff’s path into clinical research began with a personal family tragedy. He now spends much of his time helping inspiring thinkers deliver the presentation of a lifetime. A magna cum laude graduate of Harvard Law School and a mostly recovered lawyer, he has published on health sciences in the Harvard Journal of Law & Public Policy and the Yale Journal of Health Policy, Law & Ethics. Last year, he and his team conducted over 50 cross-sector interviews focused on problems and possible solutions in clinical trial navigation. His best work was as a championship-winning middle school basketball coach.