Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.
The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.
Clinical News Roundup for the week of July 16, 2017 with information on NIH’s new definition of clinical trials, Hispanics in trials, misleading registrations on clinicaltrials.gov, clinical trials in South Korea, and more.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.
In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).