Business Problem

To comply with Federal regulations on Clinical Trial Disclosure, the Clinical Trial Transparency Group needed to develop strategies and plans for new Protocol Registrations on Global Clinical Trials registries (such as ClinicalTrials.gov); maintenance of existing records on ClinicalTrials.gov; and Reporting Clinical Trial Data to meet Food and Drug Administration Amendments Act (FDAAA) regulations.  

Hawkins Point Solution

Hawkins Point evaluated information systems used by the different functional teams (Global Clinical Operations, Medical Writing, Regulatory & Data Management) to provide assessments for identification of new protocols to be registered. Also, Hawkins Point was able to provide reviews of completed trials for data reporting and active trials for new updates. 

Results

  • IdentifiedClinical trial protocols to be fast-tracked for registration
  • CompletedAssessment to assist clinical trial registration and planning
  • DevelopedAction plan to address any clinical trials requiring data disclosure