Confidence Beyond Compliance
Clinical trials play a crucial part in any clinical development program. As well as gaining information on a product’s efficacy, they also have a similarly important role in furnishing information on safety. The process for the gathering and reporting of the trial data must conform to regulatory requirements.
PharmaLex offers services for commercial and non-commercial sponsors to fulfil their safety reporting requirements.
We have many years’ experience in developing robust clinical study safety processes. We can design and implement safety procedures, management of Serious Adverse Event (SAE) including narrative writing and data entry in database, codifying event terms according to MedDRA, as well as concomitant medication with the World Health Organization (WHO) drug dictionary, prepare and send of follow-up requests, expectedness assessment of Serious Adverse Reactions (SARs), complete standard reporting forms (CIOMS I, Medwatch), unblinding, report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the National Competent Authorities (NCAs), Ethics Committees (ECs), Institutional Review Boards (IRBs), and investigators, as well as prepare and submit Development Safety Update Reports (DSURs). In addition, we can advise on or redact the safety sections for Investigator Brochures (IBs) updates and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests.
What our clients say
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe