Good Clinical Practice(GCP) Support Services for Pharma and Biotech Industries

Good Clinical Practice

Pharmatek team encompasses of qualified and trained subject matter experts (SME) to deliver quality services meeting the regulatory compliance.

Our highly experienced, trained, and competent team of specialist GCP auditors has conducted audits in a broad range of therapeutic areas including oncology, cardiovascular, respiratory disease, central nervous system, infectious diseases, ophthalmology in phase I through IV of clinical research according to international and national regulations and guidelines.

Here at Pharmatek, we have built a strong and agile team of GCP audit professionals with decades of experience in GCP audits. Our SMEs are globally experienced and executed audits across the world in USA, EU, Canada, Asia Pacific countries including Japan and Australia.

For all audit projects, our team adhere a standard process for planning, preparation, execution and reporting as per defined customized audit plan. Each of our audit report endure a peer review process to ensure the audit outcome meets each client’s high standards.

Pharmatek solution

Our range of GCP services include

Investigator Site Audits

  • Phase 1 to Phase IV

Vendor Audits

  • Pre-qualification audits
  • Clinical Trail supply / Drug Depot Audits
  • Interactive Response Technology (IVRS/IWRS) Audits
  • Central Imaging Facility Audits

Institutional Review Board (IRB) Audits

  • Systems and Process

Central Lab Audits

  • Sample Management
  • Clinical Lab

Trail Master File Audits

  • Manual and Electronic TMF

System / Process Audits

  • Electronic submission audits
  • Clinical operations and monitoring,
  • Data entry and data management
  • Statistical and Biostatistical department
  • Medical writing department

Pharmatek GCP audits are customized for your specific project and budget needs. We can provide assistance with all aspects of your projects, including audit plan development, audit scheduling, audit conduct, audit reporting, and audit follow-up services (e.g., review of audit responses). We conduct general qualification audits, program level audits and study level audits.

Auditor(s) are acquaint with on-site as well a remote audit. Many of our audits conducted remotely, helping our clients to maintain their audit programs during the unprecedented time.