Redaction of your CSR’s will be critical

News

Redaction of your CSR’s will be critical

FDA takes step in direction of EMA Policy 0070 for public disclosure of clinical data: Redaction of your CSR’s will be critical.

On January 16th, the U.S. Food and Drug Administration announced a pilot program (1,2) to evaluate whether disclosing certain content included within clinical study reports (CSRs) following approval of a NDA, improves public access to drug approval information. This looks like the first steps towards something similar to EMA Policy 0070 (3) i.e. public disclosure of documents from marketing authorisation applications.

As the FDA’s release states “Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.”

Kinapse offers end-to-end Clinical Trial Disclosure services (4). Depending on your organisation’s needs, we can provide advice on requirements, build our recommended capability solutions and then support delivery of any required activities. From protocol registration through to results posting, we’ve got your clinical team covered.

Currently, the regulatory demands our industry faces are only increasing. For instance, the recent EMA Policy 0070 is forcing companies to manually anonymize and publish clinical reports. In support of this, we have developed our redact360 solution (5), which combines our deep trial transparency expertise and an innovative technology for the redaction, anonymisation and risk assessment of clinical documents for public disclosure. For EMA Policy 0070, redact360 enables you to redefine your approach, release your resources and reduce your compliance burden.

Over the last 10 years we have completed more than 10,000 trial transparency deliverables for leading biopharmaceutical clients. Our combination of an off-the-shelf CTD solution (redact360), together with an expert team of CTD professionals, and the greatest depth of experience and track record of success in the industry, means that Kinapse is the market leader in making clinical trial information publicly available.

1https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592566.htm

2https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm589210.htm

3http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/04/WC500225880.pdf

4https://kinapse.com/clinical-trial-disclosure/

5https://youtu.be/b3twpnq98EM https://www.youtube.com/watch?v=b3twpnq98EM&feature=youtu.be

2018-03-23T14:09:36+00:00