tranScrip identifies, implements and leads full drug safety, pharmacovigilance and risk management programmes for regulatory approvals, label extensions and safety monitoring, through a team of expert senior physicians and safety scientists.
tranScrip’s Drug Safety and PV team has worked on a wide range of projects, from early clinical development through to post licensing pharmacovigilance. tranScrip supports ongoing signal management activities, develops safety documentation, offers EU Qualified Person for Pharmacovigilance (QPPV) services and relevant training programmes.
Experienced, hands-on drug safety specialist are paramount in negotiating the dynamic maze of new pharmacovigilance (PV) regulations.
The services that tranScrip provides include, but are not limited to:
- Safety writing including
- Developmental Safety Update Reports
- Periodic Benefit Risk Evaluation Reports
- Safety Responses to Health Authority Requests (pre and post approval)
- Risk Management Plans
- Developmental Risk Management Plans
- Safety Narrative Writing
- Post Approval Safety Study planning
- End-to-End Safety Signal Management
- Pharmacovigilance Inspection Readiness
- Pharmacovigilance Training
- Advisory Board Preparation
tranScrip has led drug safety programmes to successful regulatory outcome as described in the case study below.
A company with a major marketed oncology product loses the Lead Clinical Safety physician, threatening defence of the label at EMA and FDA and further development plans.
tranScrip provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.
The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.