Clinical Research

Pharmacovigilance and Drug Safety Expertise

Regulatory Affairs

 

Pharmacovigilance and Drug Safety Expertise

We support pharmaceutical and biotechnology companies in US, Europe, Canada and Asia. Our expertise covers both the clinical and post-market arenas.
Our Pharmacovigilance and Drug Safety group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices. We provide a comprehensive PV service, including Qualified Person for Pharmacovigilance (QPPV), which is tailored to suit individual companies' requirements. We are fully compliant with ICH, FDA and EMEA standards. We provide a complete package of drug safety services which are specifically tailored to meet your needs.
Our Services include:
Management of adverse events: Our drug safety services include the full management of adverse events originating from pre- and post-authorization studies and spontaneous reports, access to a validated drug safety database, expedited reporting in accordance with the national and international requirements, medical information services, writing services of all safety-related documents, and support in creation and management of your standard operating procedures.
Safety Reports: Our experienced drug safety and medical writing personnel will be preparing all safety reports. They will ensure that safety aggregated reports are well-written, compliant with the latest standards and delivered on time.
Periodic Safety Update Reports (PSURs): Periodic Safety Update Reports (PSURs): We have extensive experience in preparing 6 monthly through to 3 yearly PSURs and renewals (and associated Bridging Reports and Addendum Reports).

  • Annual Safety Reports (ASRs)
  • Summary Bridging Reports (SBRs)
  • Individual Case Safety Reports (ICSRs)
Risk Management

Risk Management Plans (RMPs): With proactivity in drug safety now obligatory, we have experience in the preparation of RMPs to comply with European standards, as well as creating Risk Evaluation and Mitigation Strategies (REMs) to satisfy US requirements.

  • Safety Operations Our team has experience working on different databases such as Argus, ARISg, Oracle AERS, Empirica Trace,Clintrace and various in-house databases.

Our operations include:
  • Case processing (data entry, narrative, causality assessment and MedDRA/WHO coding)
  • Literature monitoring
  • Quality control
  • Follow-up requests
  • Reporting to Health/Regulatory authorities
  • Data reconciliation and Query Management
  • Compliance measurement
  • Regulatory intelligence
  • Pharmacovigilance training
  • Medical information
  • Auditing services
  • Pharmacovigilance consulting
  • SAE Management and Reconciliation
  • Case Narrative Writing
  • Medical CodingMedical Coding - MedDRA, WHO - ART, COSTART, WHODRUG
  • Safety Signal Detection
  • Epidemiology Consultation

Evaluates adverse event reports, assesses regulatory status which is seriousness and Expectedness/relatedness in order to prioritize workload. Processes adverse event reports from clinical trials and from marketing activities as per Company Standard Operating Procedures and guidelines for maintaining regulatory compliance. Performs risk and quality function on adverse event reports including manual coding as needed. May perform risk and quality function on adverse event reports including manual coding as needed. May request Quality Assurance analysis on appropriate cases according to SOP. May determine need for and request follow-up using appropriate communication methods (eg. fax, email, telephone or site visit) Participates in team discussion for both processing and product knowledge. Prioritize workload for product and liaise with other Safety Associates to ensure timely processing. May determine the need for and request follow-up using appropriate communication methods (eg fax, email, telephone or site visit) May represent safety operations at clinical development meetings

   
   

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