In late 2025, Tufts CSDD and CRIO conducted a survey among a global community of investigative sites to better understand how sites translate clinical trial protocols and related information into practical tools such as template source documents, study plans, calendars, worksheets and shadow charts for the purposes of ensuring compliant, efficient, and high-quality data collection. In total, 209 sites from a variety of settings responded. This session will review key takeaways from this research and discuss their implications.
This source preparation process is not well understood and the lack of standardized terms describing the process are a source of confusion. At the same time, it is widely acknowledged that the process of source document preparation at investigative sites is inefficient and highly fragmented. This webinar will provide an overview to the comprehensive mapping of systems and workflows that investigative sites use to capture, manage and transmit clinical research data; characterize pain points and challenges that drive delays; and identify opportunities to improve efficiency, speed and quality.
The webinar will begin with a short presentation of the study results. Next, a panel of investigative site representatives will discuss the findings and insights.
Key learning objectives:
- Review the typical site workflow for preparing source documents and the critical and rate-limiting documents needed
- Examine the roles and work effort required to prepare source documents and how this varies based on protocol complexity
- Discuss the wide range of paper and electronic systems that sites use to capture relevant study information
- Identify opportunities for sponsors, sites and service providers to enhance the protocol-guided source preparation process and accelerate study activation times
Speakers:
Rick Ward – Moderator, Chief Commercial Officer, CRIO
Rick is a proven commercial team leader with a track record for driving successful growth strategies at multiple dynamic eClinical solution providers including CluePoints, Greenphire, and Trifecta Clinical. A graduate of the Pennsylvania State University, Rick has presented at multiple industry conferences including SCOPE, DPharm, Global Site Solutions Summit, Patients as Partners, Clinical Trials Congress, ACRP, and the DIA Outsourcing Summit as well as serving in an advisory role for various other industry conferences.
Beth Harper – Senior Research Analyst for the Tufts CSDD, and the President of Clinical Performance Partners, Inc.
Beth is a seasoned clinical research professional who has held multiple roles across all types of organizations (sites, CROs, sponsors, service providers) throughout her 40-year career.She has passionately pursued opportunities to optimize the clinical trial process, accelerate patient enrollment, enhance sponsor/site relationships and to build the competency of the clinical trial workforce.
Greg Manning, MS, CCRP – Vice President of Operations, Atlas Clinical Research
Greg Manning is Vice President of Operations at Atlas Clinical Research, where he leads operational strategy across a growing network of clinical research sites. With more than 18 years of experience in site operations, he brings deep expertise across regulatory strategy, clinical workflows, and research operations. Greg focuses on building scalable systems that help sites and industry partners run studies more efficiently, support investigators, and accelerate the delivery of new therapies to patients.
Aneesh Vaze – Managing Director, Clinical Research Philadelphia
Aneesh Vaze is the Managing Director of Clinical Research Philadelphia (CRP), one of the region’s most experienced dedicated clinical research sites. Since 1996, CRP has completed more than 500 clinical trials across a wide range of therapeutic areas, with a strong focus on expanding patient access, improving diversity, and running studies efficiently.Before joining CRP, Aneesh was a Principal at Herspiegel Consulting, where he advised pharmaceutical and biotech companies on regulatory strategy, market access, and product launches across oncology, rare disease, and specialty therapies. That experience gives him a strong understanding of what sponsors need from sites—and how to deliver consistently. Aneesh is passionate about building practical, scalable research operations that make it easier for patients to participate in clinical trials and help bring new therapies to market faster.