June 24th 2025
As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.
Academic Research Under the Clinical Trial Regulation – Partial Relief?
May 1st 2017This 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).
New Clinical Trials Law in France: Advantages for Medical Device Studies
May 1st 2017The 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.
Putting Safety at the Center of Clinical Studies
March 27th 2017For several decades, life sciences companies’ clinical development of products has focused predominantly on efficacy and specific mechanisms of action to drive efficacy forward. But as competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, progressive companies are exploring safety as a product differentiator during the clinical trial process. Cheryl Key explores that development.
FDA's Decision on Sarepta's Exondys
October 20th 2016The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.
CDISC Standards Key to Meeting FDA Regulations, Research Goals
October 14th 2016The 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.
Digital Transformation of SAE Data Capture in Clinical Studies
September 20th 2016Processes 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.
Regulatory Approval in India: An Updated Review
May 4th 2016Issues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.
Tips to Get to (and through) FDA Approvals Faster
April 29th 2016While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.
FDA’s Breakthrough Designation is Working
April 15th 2016The FDA’s breakthrough drug initiative is accelerating clinical development of new therapies. A recent analysis found that pre-market development time for breakthrough-designated drugs is 2.2 years shorter than for those without the designation.
FDA Looks to New Techology, Policies to Streamline Clinical Research
February 1st 2016Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus for FDA.