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The August 1, 2019, R3 meeting will address two topics: (1) Exporting from China for Research: Biospecimens, DNA and Data and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies.

Global Regulatory Engagement

Real World Evidence

OptumLabs and MRCT Center announced that two academic institutions were awarded grants to support replication of established clinical trials through the use of electronic health record and claims data.

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Ethics, Conduct, and Oversight

Impact of GDPR on Clinical Research

The MRCT Center, in collaboration with Ropes and Gray, has led an effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health.

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Focus Areas

Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.