PHARMACO VIGILANCE SERVICES

Do you want to outsource your whole product vigilance process or just part of it? GCP-Service can take on the whole process for small and medium sized companies (medical device companies and pharmaceutical companies), where it is not financially viable to employ the relevant experienced people.

Alternatively, our team is able to perform any specific task where your company may have a temporary lack of resources. We have a complete suite of SOPs covering all product vigilance activities interfacing with your SOPs.

PHARMACOVIGILANCE SERVICE

We can support your company with pharmacovigilance service including QPPV, PSMF, case processing and reporting, literature searching, periodic reports, safety monitoring, signal detection, maintenance of core safety information, etcetera.

CASE MANAGEMENT / ICSR PROCESSING / SAE REPORTING FOR MEDICAL DEVICE COMPANIES

GCP-Service can provide a full case management service for companies with a small to medium through put of cases. The service may include any or all of receipt, assessment and triaging, coding, data entry, quality control, medical review, follow-up, expedited reporting cases to competent authorities or partners, electronic reporting and reconciliation. We can perform tasks via affiliates, partners or directly in countries where we have the language.

ELECTRONIC REPORTING TO THE REGULATORY AUTHORITIES

The GCP-Service team is fully trained in use of the EudraVigilance Webtrader and has extensive experience in submission and receipt of ICSRs and SUSARs for a number of clients. GCP-Service can offer:

- Registration on EudraVigilance on behalf of the pharmaceutical company as Trusted Deputy

- Electronic transmission of ICSRs and SUSARs to Competent Authorities and EMA through EudraVigilance

REMOTE DATA ENTRY

Our personnel are experienced in data entry into a range of pharmacovigilance databases. To tide you over those temporary resource issues due to higher than usual case through put, staffing gaps, database upgrades or system mergers or other reasons, we can “fill that gap” by providing your database supports remote entry.

LITERATURE SEARCHING

GVP Module VI requires companies to carry out weekly literature searches in at least one “widely used systematic literature review and reference database”. GCP-Service can carry out these searches using PubMed. Alternatively, we can review the results of in-house searches routinely, documenting the review and outcome, identifying case reports and other citations that may be relevant to the safety profile of your medicinal products for PSURs and signal detection.

We can also run your literature searches for the period covered in the PSURs, in order to identify any citations relevant to the safety profile of the product(s) concerned.