Metabolic Solutions

We take a medically and scientifically informed, proactive approach to trial design, helping clients plan for specific scientific issues that may impact the efficacy and/or safety aspects of a product

GCR also guides clients through the critical — and often uniquely challenging — process of recruiting for diabetes trials. We help identify, enrol and retain the desired study population to ensure study objectives are accurately and effectively met.

Metabolic Solutions

Innovative Approach to Addressing Major Cardiovascular Events

GCR implements a systematic approach to the surveillance and adjudication processing for major cardiovascular events (MACE). Our centralised team of adjudication experts developed an electronic system that encompasses all stages of adjudication, including event identification, dossier compilation, committee submission, arbitrations and final classification of events. This system provides the following advantages:

  • Access for reviewing events and documentation from multiple data sources
  • An online interface for the endpoint adjudication committee to confirm adjudicated events or request follow-up information
  • Daily review of all new and changed adverse events
  • Immediate tabulation of adjudicated outcomes
  • Tracking of ageing of in-process events and individual committee members’ workload