Quality And Enterprise Learning

Our quality and enterprise learning experts offer a wide range of expertise.

Through our high-quality training programs and dedication to enhancing quality services we deliver effective client solutions.

global compliance

Global Quality and Compliance

When it comes to the conduct of clinical trials, quality and compliance are nonnegotiable requirements in every step of the process. Risks threaten the most well-planned drug development.

GCR’s global quality and compliance (GQC) services are delivered by trained professionals who have honed their expertise over decades of experience. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research subjects’ rights and welfare.

Comprehensive and Client-specific Expertise

  • Auditing processes, clinical trial sites, labs, vendors and pharmacovigilance activities
  • Examining report design and data analysis of audit metrics
  • Pre-inspecting activities, mock inspections and follow-up support
  • Developing risk management frameworks to escalate quality concerns
  • Implementing and managing CAPA system
  • Investigating suspected scientific misconduct
  • Advancing standards/systems for procedural document management and control
  • Progressing quality agreements and conduct of quality council meetings
  • Training on how to host regulatory authority inspections
  • Analysing training for standardisation into core curricula
  • Creating and maintaining product specification files
  • Coordinating identification testing for product import into the European Union
  • Evaluating software vendors
  • Assessing FDA 21 CFR Part 11
  • Expanding or maintaining retention schedules
  • Due diligence processing prior to disposition of business records
  • Setting up and maintaining eTMF
global compliance

Enterprise Learning

The GCR enterprise learning team offers a range of services and expertise in program development. Through our extensive experience in clinical trials and adult learning we deliver effective, high-quality training.

Enterprise learning delivers educational and learning programs that proactively, measurably and efficiently improve people’s performance, readiness and quality within a corporate level.

enterprise learning