Industry Report: CDA Guidance and Template
Accelerating Clinical Trials Through Streamlined Confidential Disclosure Agreements and Processes
The Site-Sponsor Consortium’s inaugural deliverable tackles an early bottleneck in study startup: the Confidential Disclosure Agreement (CDA). This industry report outlines why CDAs should remain simple and mutual, how to avoid common pitfalls, and when a master CDA removes rework—so study feasibility can begin sooner. The companion Master Mutual CDA Template turns guidance into action, paving a faster and simpler path to feasibility assessments, site selection, and startup planning.
New Industry Report: Reducing Redundant Site Training
Advancing Study Readiness Through Competency-Based, Role-Based, and Reusable Training Models
The Site-Sponsor Consortium’s industry report addresses a persistent barrier to efficient study startup: redundant site training. Explore a practical framework for recognizing existing qualifications, aligning training with assigned responsibilities, and focusing study-specific instruction on what is new, different, or critical to study execution. Companion papers and downloadable tools turn guidance into action, helping sponsors, CROs, and sites redesign site initiation visits, recognize prior EDC training, and reduce unnecessary repetition while maintaining participant protection, data quality, and inspection readiness.
Our vision
A future where sites, CROs, and sponsors work together seamlessly, fostering innovation, reducing complexities, and bringing life-changing treatments to patients faster.
Our mission
To expedite clinical research today by co-creating vendor-agnostic deliverables that drive progress, strengthen collaboration, and dismantle operational silos—fostered through an environment of open dialogue, shared knowledge, and strategic innovation.
Members
Jamie Bendrick-Peart
Senior Director, Innovation & Strategic Projects
AstraZeneca
Kyle Bird
VP, Clinical Research
Dana-Farber Harvard Cancer Center
Christina Brennan, MD
SVP, Clinical Research
Northwell Health
Jennifer Byrne
Chief Executive Officer
Javara Research
Kari Delahunty
Chief Executive Officer
AMR Clinical
Nicholas Fisher
Executive Director, Research & Business Administration
Alvin J. Siteman Cancer Center at WashU School of Medicine & Barnes Jewish Hospital
Nicole Stansbury
SVP, Global Clinical Operations
Premier Research
Patrick Floody
VP, Global Clinical Trial Services
Regeneron
Tamara Hughes
SVP, Study Start-Up and Site Activation
ICON
Carly Lovelett
Associate Director, Protocol Activation & Lifecycle Management (PALM)
Yale Center for Clinical Investigation
Marta León Montagut
SVP, Site Activation Center of Excellence
Parexel
Kristie Moffett
Senior Director, Human Subjects Research
Moffitt Cancer Center
Timothy Mudric
VP, Clinical Development Strategy Enablement
PPD, part of Thermo Fisher Scientific
Alison Liddy
SVP, Patient and Site Centric Solutions
IQVIA
Emilio Neto
Global Head of Country & Site Operations
Biogen
Carlos Orantes
Chief Executive Officer
Alcanza Clinical Research
Marisa Rackley
VP, Global Clinical Operations
Takeda
Michelle Rowe
Vice President
HCA Healthcare Research
Christine Senn
SVP, Site-Sponsor Innovation; Chair, Site-Sponsor Consortium
Advarra
Nick Spittal
Chief Operations Officer
Velocity Clinical Research
Ian Wyglendowski
VP, Global Head of Strategic Clinical Partnering
UCB
Brandi Walker
Executive Vice President, Global Clinical Operations
Syneos Health
Shaping the future of clinical research
The consortium is built on three core pillars:
Persistent progress
We develop and drive standards that scale beyond our organizations, benefitting
the entire industry.
Seamless workflows
We align processes across the clinical trial lifecycle—from protocol design through study execution and closeout—to reduce redundancies, speed feasibility, and improve predictability.
Open access
Transparency is in our DNA: We make solutions and best practices publicly available to all, so sponsors, CROs, and sites can remove unnecessary complexity and advance trials responsibly.
Site-Sponsor Consortium Resources
Industry Report
Accelerating Clinical Trials through Streamlined Confidential Disclosure Agreements and Processes
Industry Report
Reducing Redundant Site Training Through Competency-Based, Role-Based, and Reusable Training Models
Industry Report
SIV Companion Paper: Reducing Redundant Site Training Through Competency-Based, Role-Based, and Reusable Training Models
Industry Report
EDC Companion Paper: Reducing Redundant Site Training Through Competency-Based, Role-Based, and Reusable Training Models
Blog
Advarra Report Illuminates a Path to Stronger Site-Sponsor-CRO Collaboration
Video
Accelerating Clinical Trials Through Streamlined Confidential Disclosure Agreements And Processes
Blog
Standardizing CDAs: A Promising Way to Overcome Study Start-Up Delays
Blog
From Red Tape To Green Lights: Accelerating CDAs In Clinical Research
Podcast