Important Updates

Protocol Deviations Launches New Assets

New! Our Protocol Deviations Initiative just launched a brand new assets page, equipped with a PD Process Guide, PD Map and PD Assessment Plan. To visit the page and explore its materials, click here.

Interpretation of Guidances & Regulation Initiative Publishes New Paper on RSI

To read and download the new paper from our Interpretation of Guidances & Regulations Initiative on the evolving remit of reference safety information, click here.

How do our Member Companies Implement Patient Technology?

Our Patient Technology Initiative asked our Member Companies how they implement PT in clinical trials and shared the findings in a white paper available here.

New! Share historical trial data…

NEW! Read our new paper describing a solution to share historical trial data to enable data sharing & accelerate clinical development across the biopharma industry here.

Toxicology Data Sharing Paper on Better Decision Making

To read and download our “Toxicology Data Sharing: Leveraging Data Sharing To Enable Better Decision Making In Research And Development” paper, click here.

Merck & Co., Inc Discusses the Value of TransCelerate’s Clinical Quality Management System Framework

We have a new podcast from our Member Company, Merck & Co., Inc., on the value and implementation of a clinical QMS.

Global pharmacovigilance regulations: Call for re-harmonization

TransCelerate implores representatives for regulatory authorities to work with industry sponsors, in the spirit of ICH, to identify potential ways to re-harmonize global pharmacovigilance processes and requirements. Read it here.

New Paper! Accelerating Adoption of Patient-Facing Technologies in Clinical Trials

In a recently published article, the Patient Technology Initiative describes the potential for patient-facing digital technologies to serve a variety of functions in clinical trials.

eLabels Launches Design & Delivery Toolkit

The eLabels Initiative recently launched a new Design & Delivery Toolkit, as well as other educational materials. Check out the assets page to access this helpful information.

What is the Clinical Trial Registry of the Future Concept?

Check out new videos, research papers and infographics on solutions that aim to better inform patients by facilitating improved touchpoints with information about clinical research and specific clinical trial opportunities.