Full service clinical trial management

While having some distinct advantages – world renowned scientific researchers and an Asia-Pacific track record - George Clinical also offers all the essential elements required to conduct high-quality clinical research:

  • Expertise in design and management of trials
  • Advanced protocol and strategy development
  • Clinical monitoring and project management
  • Rigorous quality control and assurance
  • Biostatistical services
  • Data management expertise
  • Understanding of regulatory requirements
  • Collaborative working partnerships
  • Extensive reporting and publishing of findings
  • An experienced team of clinical trial experts

Data management

George Clinical's scientific expertise is backed up by data analysis capabilities. The Data Management Team have skills in the areas of EDC, SAE and AE reconciliation, coding, extraction, electronic import of data such as laboratory results, discrepancy management and querying resolution, database lock and study closure.

The Clinical Data Management system used is a combination of ClinTrialTM and InFormTM. Both these products are FDA 21CFR part 11 compliant, and as part of the implementation process we have a fully audited and FDA-compliant system.ClinTrialTM and InFormTM allow George Clinical to output data in a CDISC - compliancy structure, if submission to a regulatory agency is required, as well as directly into SAS.

The system allows George Clinical to offer classic paper-based clinical trials through to full EDC trials with paperless submissions. In the area of EDC trials we have over five years experience and have successfully run six EDC trials, the largest of which had an excess of 10,000 patients. The time elapsed from last patient last visit (LPLV) to database lock on this study was nine days.

Biostatistics

George Clinical has its own Statistics Division which provides full statistical services to international regulatory 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.