Important Updates

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.

New eConsent Implementation Guidance & Tools

The eConsent Initiative has developed practical guidance and tools describing potential implementation considerations and eConsent components. Check out our eConsent Initiative Asset page for more info.

New Common Protocol Template Materials and Video!

The Common Protocol Template Initiative launched its tech enabled protocol template in alignment with the FDA and NIH. Check out our CPT Initiative Asset page for helpful materials and our brief overview video.

New Implementation Tools and Guidance Papers for the CDT Initiative

The CDT Initiative now has new implementation tools and guidance papers available via download.

Optimizing the Use of Electronic Data Sources in Clinical Trials

The eSource Initiative published its first landscape paper, Optimizing the Use of Electronic Data Sources in Clinical Trials. Read it here.

Infographic: QMS Initiative’s Conceptual Framework

This infographic reviews our conceptual framework for a clinical QMS. Take a quick look and then read our latest article in TIRS.

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