Newsletter | July 11, 2024

07.11.24 -- ICH E6(R3) And Defining What Is Critical To TMF Quality

FEATURED EDITORIAL

ICH E6(R3) And Defining What Is Critical To TMF Quality

By Ken Keefer, MBA, PMP, Keefer Consulting Inc.

By implementing Quality by Design principles in clinical trials, sponsor companies can enhance the role and significance of the Trial Master File (TMF) under ICH E6 (R3).

INDUSTRY INSIGHTS

Site-Centric Clinical Platforms Are Better For Sponsors

Webinar | Cognizant

Discover how seven of the top 15 global biopharmaceutical companies came together on a single clinical technology platform and operated through common workflows and common trial documents.

eConsent For Complex Clinical Trials

Article | By Karen Maduschke and Vinita Navadgi, IQVIA Technologies

Master protocol design trials require an endless stream of consent forms, adding time, cost, and risk. Learn how a feature-rich eConsent platform can simplify those processes and improve engagement.

Our Unified Platform Serves As eSource For COVID Treatment Trial

Case Study | Signant Health

Signant Biotech optimized technology for an emerging biopharmaceutical's Phase 2 COVID treatment trial, reducing paper data risks and streamlining consent and data management.

Study Start-Up Checklist For Digital Clinical Trials

Article | Florence Healthcare

Read how five Florence employees with clinical research backgrounds came together to craft a checklist designed to walk sites through the process of tech-enabled study start-up.  

The Win-Win Wth Virtual Visits – Better Experiences, Better Data

Article | Crucial Data Solutions

Design studies with the needs of the patient in mind to promote faster enrollment, high engagement, and the production of more complete and accurate data.

Linking Clinical Trial Data With Real-World Data: Q&A With HealthVerity

Q&A | Medidata AI

Director of Partners and Alliance Management at HealthVerity KC Ahlberg discusses key trends related to the use of RWD in clinical trials, and the value sponsors are realizing through data linkage.