Global and Local Pharmacovigilance Services, since 2008

CT documentation development.

Clinical trial documentation review.

We understand the criticality of having a thorough protocol prior to study initiation, and we can advise you on the best approach to set-up the safety section during protocol writing and finalization.

In addition to your protocol, our consultants can provide a full review of your reference safety information (e.g. as part of the Investigator’s Brochure), contracts, final study reports, and other documents.