In our July/August issue:
PEER-REVIEWED ARTICLE
FDA Form 1572: Global Considerations
Natalia Buchneva
Report explores the pivotal questions and procedures around signing–or not signing–FDA Form 1572 (Statement of Investigator) for investigators, sponsors, and CROs involved in multinational clinical trials with U.S. and non-U.S. sites.
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FEATURED
The Power of Predictive Analytics
Stephen Arlington, PhD, Paul Chew, MD, Annalisa Jenkins ,MBBS, FRCP, Gen Li, PhD
Clinical trials don't have to be lengthy and costly. Authors present an example of how employing predictive data analysis to uncover site performance patterns can boost trial planning and execution.
Blockchain: A Prime Data Notary?
Artem Andrianov, PhD, Boris Kaganov, PhD
Examining the potential of using blockchain technology as a notary service to reduce systemic risk, increase data quality, and decrease risk of fraud during clinical trials.
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NEWS
Washington Report: Jill Wechsler on new FDA strategies in action to streamline research and oversight of advanced therapies.
EU Report: Peter O'Donnell gauges the EU's level of seriousness in addressing and reshaping future health policy.
Clinical Outsourcing: New report forecasts accelerated growth in the global market for CRO services over the next few years.
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CISCRP CORNER
Patient Experiences with Drug Administration
CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger
The latest series of results from CISCRP's Perceptions & Insights Study finds that providing easy to understand and culturally appropriate medication education and support can go a long way to improving the patient experience. |
CLOSING THOUGHT
Answering 6 Key Questions During Audits
Stefan Düerr
Switching from paper records to an electronic drug accountability IRT system can benefit sites and sponsors during FDA clinical trial audits.
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