PHARMACOVIGILANCE AND MEDICAL WRITING SERVICES

At Cispact, our key focus is to ensure patient safety and product quality through our highly customisable and detail-oriented pharmacovigilance services. Our team boasts of experts who support clinical trial and post-marketing safety surveillance across the globe for various pharmaceutical, biotechnology and medical device companies. As well trained and highly qualified experts, the team at Cispact works seamlessly across various therapeutic areas to ensure the successful delivery of pharmacovigilance services to our customers. We adopt the best industry practices in assessing, analysing, and evaluating the safety profile of the products at an exceptional level of quality. Right from pre-marketing to post-marketing pharmacovigilance activities to support services, Cispact justifies every service throughout the entire process.

Clinical Trial Safety Services

  • End to End Clinical Trial Case Processing
  • Developmental Safety Update Reports
  • Clinical Study Configuration
  • Un-blinding of CasesData Reconciliation -Clinical and Safety
    Database
  • Investigator Brochure Creation and Update
  • Clinical Trial Protocol Writing and Review

Post Marketing Safety Services

  • End to End Case Processing
  • Aggregate Reports - Writing and Review
    (PBRER, PSUR, PADER, SUSAR Reports and
    ARs)
  • Safety Signal Detection & Management
  • Risk Management Plans
  • SmPC Update for Generic Molecules
  • Company Core Data Sheet Update
  • Literature Screening and Review
  • 24/7 Medical Information Call Center

Medical Writing Services

  • Informed Consent Forms
  • Protocol Synopsys Preparation
  • Preparation of Patient Safety Narratives

Technology Services

  • Process Automation and Validation
  • Global Safety Database Creation and
    Validation
  • Global Safety Data Migration, Archiving and
    IT Recovery Systems

Other Services

  • Process Automation and Validation
    SOP Development
  • Regulatory Audit & Compliance Support
    Training
  • Setting up of End to End PV System
    EU and Local QPPV Services

 We at Cispact consider drug safety the most essential aspect for a successful clinical project/trial and hence assure and abide by the highest quality drugs. 

X