CT documentation development

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 clinical safety consultants can provide a full review of your Reference Safety information (in the Investigator’s Brochure), contracts, clinical/final study reports, and other documents.

Selected PV Case Studies.

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ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Local PV, regulatory strategy
Complex pharmacovigilance local support

What our clients say about us.