Mar 07, 2018
Applied Clinical Trials
The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.
Feb 12, 2018
Applied Clinical Trials
The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.
May 17, 2017
The majority of pregnant women are prescribed treatments that can include antibiotics, antivirals and more. However, little to no information is available about the appropriate dose to prescribe or the potential adverse fetal effects.
May 01, 2017
The new law on research in France introduces changes for the medical device industry by facilitating the conduct of postmarketing studies. Devices will no longer have to be provided free of charge for low-risk interventional studies making France a possible location for such trials in the future.
May 01, 2017
This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).
Mar 27, 2017
As competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, pharma companies are exploring safety as a product differentiator during the clinical trial process.
Feb 24, 2017
Patient advocates are witnessing a shift in the culture of drug development as sponsors and regulatory agencies show more interest in incorporating patient perspectives.
Oct 14, 2016
The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.
Sep 20, 2016
Processes for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.
Aug 01, 2016
Clinical trial noncompliance is an industry concern that persists today resulting in 483s being charged to study sites. Bill Tobia discusses his recently developed “No 483 for Me” app for helping study sites avoid common noncompliance practices during clinical trial conduct.
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