Quality, Regulatory, Clinical

What We Do

Clinical Trial Support

Support for Early Phase Clinical Trials:

Project management of early phase clinical trials, including:

  • Healthy volunteer studies at Phase I commercial trial units – globally
  • Hospital-based trials at UK centres
  • Set-up, maintenance and closeout, including Research Ethics Committee (REC) and Health Research Approval (HRA) management
  • Vendor selection and management

Monitoring of early phase clinical trials:

  • Selection, Initiation and Monitoring of Commercial Phase I units (Global) and Hospital Sites (UK)

Electronic and paper Trial Master File (TMF) set-up, management and closeout:

  • Utilising Veeva Vault, a cloud-based Content Management System, designed to support the management of essential trial documentation

Essential document writing and review:

  • Clinical trial protocols
  • Investigator Brochures
  • Clinical Study Reports
  • Informed Consent documents
  • EudraCT and Clinicaltrials.gov data upload

Interim clinical project management, including:

  • CRO selection
  • CRO oversight, including co-monitoring of CRO-managed trials

Feasibility studies:

  • Potential Investigator Questionnaires & tailored interviews

Bespoke training in GCP & the clinical trial regulatory environment:

Bespoke training in GCP & the clinical trial regulatory environment