Clinical Research Management Briefing - May 21, 2018

This week, the European Union will start to enforce new regulations under the General Data Protection Regulation (GDPR) about how personal data is collected and protected – whether or not the policy is understood.

The New York Times, May 15

USAF, NSF Partner for National Security R&D Effort

The U.S. Air Force (USAF) and the National Science Foundation (NSF) will begin working together to increase research and development in the areas of space, geoscience and data science.

ExecutiveGov, May 10

Regulatory

NIH: ‘If We Don’t Report Our Results We Will Repeat Mistakes’

Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.

Outsourcing-Pharma, May 16

HHS Announces Planned Rules Affecting IRBs and Clinical Trials

The Department of Health and Human Services (HHS) is due to announce several proposed rules regarding Institutional Review Boards (IRBs) and clinical trials.

CenterWatch, May 14

Financial and Operations

Experts Debate Methods to Overcome Clinical Trial Enrollment Barriers

Research experts gathered to discuss ways to increase enrollment by improving social, economic and patient awareness barriers.

CenterWatch, May 14

Technology

Blockchain Concepts Emerge in Clinical Trials

The head of new clinical paradigms at Pfizer shares the current trends and his predictions for blockchain use in the pharmaceutical industry.

Applied Clinical Trials, May 8

Spotlight

FDA Issues Final Guidance in Effort to Protect Clinical Trial Participants

Tom Bechert, director at Huron, comments on the Food and Drug Administration’s (FDA’s) final guidance in its efforts to improve protection for participants in clinical trials and reduce regulatory burden.

Outsourcing-Pharma, May 17