Clinical Trial, Generating High Quality Clinical Data
Acceptable to Major International Regulators
Our experience across all aspects of a clinical development programme means that we are able to provide technical advice as well as offering a broad range of clinical development services.
We have the capability to engage in the complete life cycle of a clinical development programme from providing strategic input into the development programme and trial design, through to project management of trials locally and/or internationally on the client's behalf.
Any of these services can be provided by Mitchell Clinical Consulting directly or in conjunction with existing in-house expertise.
We have also had extensive experience in managing all aspects of Outsourcing.
The following are examples of key trial activities that are available as "stand alone" services, or may be embedded within in-house or project management services.
- Clinical study protocols
- Feasibility assessments / site selection
- Investigator Brochures
- Clinical sections of Clinical Trials Exemption (CTX) application
- Case report form design & completion guidelines
- Ethics submissions
- Data & Safety Monitoring Board (DSMB) Guidelines & Reports
- Establishment and management of Protocol Steering Committees
- Clinical Project Management
- Monitoring of clinical studies
- Clinical study reports
- Writing & review of standard operating procedures
- Liaison with data management organisations and other third-party providers