We are apologize for the inconvenience but you need to download
more modern browser in order to be able to browse our page

pharmacovigilance

Safety of medicinal products is one of the main responsibilities during clinical development and after registration

Our integrated team of skilled professionals are highly experienced in drug safety, pharmacovigilance, and pharmacoepidemiology and understand the changing regulatory environment.

Our full range of services offer flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support.

DATACLin creates value across all areas of pharmacovigilance

For Pharmacovigilance, we provide the following solutions :

 

Pharmacovigilance Post Authorization Services

  • Outsourcing of Qualified Person for Pharmacovigilance (QPPV).
  • Individual Case Safety Report (ICSR) Full Processing.
  • Expedited Case Reporting.
  • MedDRA Coding.
  • Safety Narrative Writing including Physician Review.
  • Periodic Safety Update Report (PSUR) Preparation and Submission.
  • Literature Search & Review.
  • Risk Management Plan Production, Review and Harmonization.
  • Safety Data Exchange Agreements (SDEA) Preparation.
  • Pharmacovigilance System Master File (PSMF).
  • Reviews, Analyze and Assesses In-house Safety Data.
  • Prepares and Reviews Risk/Crisis Management Strategies.

Pharmacovigilance Clinical Trial Services

  • Serious Adverse Event Case Full Processing.
  • Serious Adverse Event Case Reporting.
  • MedDRA Coding.
  • Study documentation Review and Update, including Protocol and Investigator’s Brochure.
  • Reconciliation of Serious Adverse Events.
  • Periodic Reports (DSURs, Line Listings, ad hoc Report).

Support Services

  • Writes SOP related to Organization, Infrastructure, and Workflow for Clinical Trial and Pharmacovigilance Activities.
  • Qualification Audits.
  • Training for Pharmacovigilance & Non-Pharmacovigilance Staff by Internal & External Global Instructors.
  • Assistance with urgent requests from regulatory authorities.

Clinical Supplies Service

Lifecycle Management

  • Product forecasting.
  • Management of Third-party Packaging and Labeling.

Procurement and Storage

  • Purchasing commercial and ancillary products.
  • Temperature-controlled warehouses.
  • Refrigeration and Freezer Storage.

Distribution

  • Controlled Shipping Conditions.
  • Assistance with import/export licensing.

Drug accountability and Destruction

  • Organization of returns with trusted courier companies.
  • Disposal as per client’s wishes, using trusted destruction vendors.