Full service clinical trial management

George Clinical offers all the essential elements required to conduct high-quality clinical research, including:

  • Expertise in design and management of trials
  • Advanced protocol and strategy development
  • Rigorous quality control and assurance
  • Biostatistical and data management expertise
  • Understanding of regulatory requirements
  • Collaborative working partnerships
  • Extensive reporting and publishing of findings.

Data management

Our scientific expertise is backed up by extensive data analysis capabilities. The Data Management Team have skills in EDC, SAE and AE reconciliation, coding, extraction, electronic import of data, discrepancy management and querying, and lock and study closure. We have staff trained to pharmaceutical standards in all these areas.

The data management system we use is a combination of ClinTrial and InForm. Both these products are FDA compliant, and as part of the implementation process we have a fully audited and FDA-compliant system.

Biostatistics

George Clinical has its own Statistics Division which provides full statistical services to FDA standards, including study designs, statistical analysis plans, interim reporting to Data Safety Monitoring Boards and final analyses.

Our biostatisticians have many years of combined experience in the design and analysis of clinical trials and are familiar with a wide range of therapeutic areas, including cardiology, neurology, endocrinology, oncology, infectious diseases, pain control and substance abuse.

Endpoint management

George Clinical has an experienced, dedicated endpoint management team who recently facilitated the document collection, translation and adjudication of over 5,000 endpoints reported for the ADVANCE study.