“At GCP-Service, safety of patients always comes first!”
– Gayane Kiragosyan, Product Safety Officer
Fulfilment of global medical device vigilance and pharmacovigilance obligations are essential for patient safety and regulatory compliance. GCP-Service Product Vigilance Department has experience in managing 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 throughout clinical development and the product life cycle that may arise along the way.
GCP-Service safety services are fully integrated with our regulatory, data, medical and clinical teams, ensuring our clients have access to all required expertise to effectively manage patient safety.
GCP-Service Vigilance Solutions and Services
Our team of experts are ready to support you in every step of safety project management, aggregate reports, safety surveillance and risk management/mitigation, PV operations and medical review, QPPV (EU and local Responsible person) and safety consulting.
Get in touch for safety support including but not limited to:
- Validated PV system
- Clinical and Post-marketing PV Services (outsourced services)
- Case Intake and Handling
- EMA Database
- Global and Local Literature Screening
- Aggregate reports (e.g., DSUR, PSUR)
- Signal Detection
- Risk Management Panning
- Medical Expert Advice and Assessment
- Qualified Person Responsible for the PV (QPPV) representation – EU and local
- Responsible Person for EudraVigilance
- PV Regulatory Compliance
Expedited Reporting (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.