Newsletter | March 28, 2025

03.28.25 -- A Decade Of Data Sharing: Insights From J&J And Yale's YODA Project

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The CMO Summit 360°®, happening April 7-8 in Boston, is the largest gathering of biotech Chief Medical Officers across indications, modalities, company stages, professional experience levels and geographic locations. This is the conference to connect with peers and develop the skills needed to succeed as a biotech CMO.

CLINICAL DATA MANAGEMENT & ANALYTICS

A Decade Of Data Sharing: Insights From J&J And Yale's YODA Project

Guest Column | A conversation with Joseph S. Ross, MD, MHS, and Karla Childers, MS

Joseph S. Ross, MD, MHS, and Karla Childers, MS reflect on a decade of data sharing and the lasting impact of the Yale University Open Data Access (YODA) Project. 

The Value Of Continuity: Program-Level DSMBs

Article | By Barbara Schneider, Ph.D., James Riddle, Advarra

Discover the strategic benefits of deploying consistent Data Safety Monitoring Boards (DSMBs) members across therapeutic programs.

5 Ways Lab Data Can Help Commercialize Your Therapy

Article | Quest Diagnostics

In this text, we delve into five pivotal insights for leveraging lab data effectively.

Shorten The Path: From Discovery To Approval Of Novel Therapies

Case Study | Medidata AI

Unearth how this trial design solution was able to utilize historical trial data and real-life examples across different indications throughout the clinical development process in five case studies.

Data Management Solution Utilized For A Cancer Immunotherapy Study

Case Study | Palleos

Check out the results from a clinical first-in-human study evaluating the safety and tolerability of an investigational cancer immunotherapy in patients with advanced melanoma.

TRIAL MONITORING

Solving The Protocol Deviation Puzzle With FDA Draft Guidance

Guest Column | By Leila Cupersmith, Choice ClinOps

Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.

CRO Uses CRIO eSource To Double Monitoring Productivity

Case Study | CRIO

Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.

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