Outsourcing

Do you want to outsource your whole pharmacovigilance process or just part of it? DSSL can take on the whole process for small and medium sized 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 resource due to increased workload or vacancies. We have a complete suite of SOPs covering all activities that interface with your SOPs and client specific SOPs detailing that interface. In addition, DSSL can offer fully experienced persons to act as the Qualified Person for Pharmacovigilance (QPPV) or deputy.

Pharmacovigilance Service

DSSL can provide a full pharmacovigilance service including QPPV, PSMF (see Support), case processing and reporting, literature searching, periodic reports, safety monitoring and signal detection, maintenance of core safety information, etcetera.

Case Management / ICSR Processing

DSSL can provide a full case management service for companies with a small to medium throughput of cases. The service may include any or all of receipt, assessment and triaging, coding, data entry, quality control, Medical Review, follow-up (via affiliates, partners or directly in countries where we have the language), expedited reporting cases to the Authorities or partners, electronic reporting and reconciliation.

Remote Data Entry

Our personnel are experienced in data entry into a range of Pharmacovigilance Databases (ARISg, Clintrace, PV Works, even MS Excel!). To tide you over those temporary resource issues due to higher than usual case throughput, staffing gaps, database upgrades or system mergers, providing your database supports remote entry, we can ‘fill that gap’.

Electronic Reporting to the Regulatory Authorities

The DSSL team are all fully trained in use of the EudraVigilance Webtrader and have extensive experience in submission and receipt of ICSRs and SUSARs for a number of clients. DSSL can offer:

  • Registration on EudraVigilance on behalf of the pharmaceutical company as QPPV or the Trusted Deputy
  • Testing with Competent Authorities through EudraVigilance
  • Electronic transmission of ICSRs and SUSARs to Competent Authorities through EudraVigilance
  • Entry of the medicinal products into the eXtended EudraVigilance Medicinal Product Dictionary

Literature Searching

Marketing authorisation holders are expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases at least once a week. DSSL already have many clients for whom we 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. We also offer review of the EMA’s Medical Literature Monitoring (MLM) output that can be tailored to your requirements.