GAP provides you bespoke or full services, for case management. Case management is the primary step for the drug safety. GAP has demonstrated strategies and best-practices for dealing with the caseload and compliance with the health authorities in every segment of case management. GAP sticks to the best industry standards and practices for information, administration, coupled with attentive, business measurements, strict timelines and work process for upgrading efficiencies. Our procedure of drug safety or Pharmacovigilance completes into four major steps which works consecutively.
Case Intake→Case Processing→Case Assessment→Case distribution
With all four steps, our team puts emphasis on the case management plan which follows the main structure of identifying the potential case, processing and assessment of adverse drug reporting, and at the end monitoring and reviewing of the case. We have good man power resource that is customer oriented people and does the assessment according to the regulatory need.
Case Intake: We process the prompt action of regulatory reporting, solving the queries and classifying the event appropriately.
Case Processing: While in case processing, we describe MedDRA or WHO drug coding, actively follow up on queries, Quality check and maintain database management of the safety database.
Case assessment: We follow the first line of medical review, signal detection, ICSR signal screening and verification of regulatory reporting.
Case Distribution: Submission of case to regulatory authority and reports needs to be sent to the sponsor.