Product Vigilance Services
The safety of patients always come first, however the reporting of safety related events within clinical trials is crucial and can be tricky. At GCP-Service we support sponsors with the challenges that the mix of medical and regulatory requirements in a clinical trial can bring.
Product vigilance outsourcing
Whether you are looking to outsource your entire product vigilance process, or just parts of it, GCP-Service is here to help.
We have experience in managing product vigilance processes for both small and medium sized medical device and biotech companies. Our team has the training and experience to help to bridge any gaps that may arise along the way.
We have a complete list of SOPs covering all product vigilance activities but of course can work according to and/or integrate your company specific SOPs.
Our Product Vigilance Department supports you:
- Safety review/preparation of safety parts of clinical trial documents (including Protocol, SAP, CSR)
- Preparation of Safety Monitoring/Management Plans for clinical trial conduct
- Individual case safety report (ICSR) processing for Serious Adverse Events (SAEs)
- Adverse Event (AE)/Serious Adverse Event (SAE) Management and Reporting
- Expedited Reporting to
- National Competent Authorities (NCA)
- Ethics Committees (EC)
- Medical Review and Assessment of Seriousness and Causality
- Literature Surveillance
- Remote Data Entry and Support.
- Aggregate Reporting Services (DSUR, PSUR, SSCP)
- Case Narratives
- Case Processing including:
- Data Entry
- Narrative Generation
- Quality Control
- Generation of AE Listing
- Medical Coding (MedDRA, ATC/DDD and WHODrug)
- Clinical/Safety Data Reconciliation of AE/SAEs
- Signal Management
- In-country Pharmacovigilance and Medical Device Vigilance Services
- EudraVigilance Profile Management
- Qualified Person Responsible for Pharmacovigilance (QPPV)
- Responsible Person for EudraVigilance (RP)
- Registration with EV Clinical Trial Module
- Safety Database Management/Hosting:
- Automatic Submission of Expedited Reports – electronic delivery and tracking of ICSR submissions to NCA (via EV Gateway and EVWEB)
- VigilanceOne (EV Gateway) – efficient delivery of safety reports to Medical Reviewers, NCA, and Sponsors
- E2B Compliant Safety Database, Generation of CIOMS Form
(e.g. through EudraVigilance)
Our team of experienced product safety officers are ready to help you with the preparation and monitoring of safety aspects throughout your study. We focus specifically on registration and validation of Safety Databases with The EMA and respective Competent Authorities keeping in mind the key task of electronic expedited reporting within regulatory timelines.
By working with two different types of electronic transmission modes: ‚Gateway‘ or ‚EV Post‘ and ‚EVWEB‘ or ‚Webtrader‘, we can choose the optimal solution based on each project level. Our inhouse gateway system VigilanceOne is customized to your needs.
Medical Device Safety
We keep medical device clients up to date with the safety aspects of their product. Providing accurate review, documentation, and summary collection of AE/SAEs is one of our standard measure. Reports are composed from case report forms of clinical trials, triage, evaluations, follow-ups etc. and ensures timely reporting to the Sponsor and Competent Authorities.
GCP-Service compiles all the necessary documents for expedited reporting internationally. We provide case narratives and take care of document submissions to Competent Authorities, Ethic Committees, and Investigators.
We support your clinical trials by compiling necessary safety data tabulation and text for aggregated safety reports such as: DSUR, PSUR, and SSCP. The expedited reporting is tailored to country specific requirements.
Our service is tailored to the workflow of pharma, device, and diagnostic companies and meets all global requirements for safety monitoring and safety reporting practices.