Global PharmaTek is an emerging CRO giving end-to-end Services in Pharmacovigilance.

We offer an extensive variety of services in Safety and Risk Management which includes state of the art call centres, case preparing and processing, well-being reports of individuals, total safety detailing reports, signal detection and risk administration and management, and counselling all in support of our customers pre-advertise improvement and post-marketing exercises. Our group of researchers, clinicians, and medicinal consultants masters in assessing risk and appraising risk. Applying imaginative advancements alongside its therapeutic mastery, Global PharmaTek imparts a firm duty on quality for its worldwide customers and accomplices bringing about better, enhanced results in a cost-productive manner.

Expert Team in Pharmacovigilance.

Our pharmacovigilance team is comprised of industry professionals with deep experience in both direct patient care and industry-specific pharmacovigilance services, enabling us to deliver safety data of the highest quality. Working globally, Global PharmaTek can provide integrated or standalone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre and post-approval settings.

ICSR Case Management

  • Post-Marketing Reports
  • Clinical Reports
  • Medico-Legal, Literature, E2b reports
  • Case triage and review
  • Data entry and MedDRA coding
  • Adverse Event Labeling
  • Narrative writing
  • Medical Review
  • SAE reconciliations
  • ICSRs and submissions
  • Safety Database hosting
  • Legacy case transfer
  • 24/7 AE call center

Aggregate Reporting

  • PSURs/PBRERs and PADERs
  • ASR, DSUR
  • Signal Detection
  • Ad Hoc Reports
  • Generation of listings
  • Integrated summaries of safety
  • Regulatory report submissions to appropriate authorities
  • Medication error and drug abuse/misuse reporting
  • COs and ACOs

Safety/IT Enabled Services

  • Designing & development of global safety data repository, post migration & integration of safety data
  • Implementation, validation, maintenance & upgrade of Argus applications
  • Integration of medical dictionaries to Argus application
  • Design, development & submission of regulatory, operational, analytical & custom reports
  • Validated and up-to-date case processing platform in a secure environment.
  • Infrastructure hosted on the cloud and maintained by Global PharmaTek
  • Training on Argus

Literature Search and Review

  • Literature searches
  • Review of abstracts and articles
  • Full-text articles procurement and translation
  • Signal detection and analysis
  • Adhoc or customized literature searches to meet specific needs

Signal Surveillance Activities

  • Ongoing medical review and analysis of cases
  • Aggregate analysis, including data mining
  • Meta-analysis of published safety data
  • Qualitative and statistical signal detection
  • Signal evaluation, assessment and reporting
  • Development of risk management and communication plans