Phase I to IV, as you would expect from a contract research organisation (CRO) but actually we do more.
Having extensive experience, we're also delighted to undertake studies with specialist requirements or with niche products.
Throughout our studies, TMC’s regulatory, medical, and PV divisions work in harmony with the clinical team.
Our services span:
Strategic Clinical Advice & Trial Set-up
TMC has highly experienced staff to initiate your clinical trials by providing;
- Clinical development plans
- Investigator brochure and Protocols including study design
- Informed Consent/Patient Information Leaflets
- eCRF development
- Study feasibility, including KOL and site identification
- Investigator Meetings
- Site contract and budget negotiation
- Ethics submissions and local approvals
- Study drug import and management
- Identification and oversight of study service vendors (eg. central laboratories, IXRS)
Clinical Trial Management
- Clinical Project management
- Risk Based Monitoring (RBM)
- Data management and statistical analysis
- DSMB/DMC set-up and management
- Trial Master File (TMF) and eTMF services
- Full clinical trial site management
TMC Functional Service Provision
Highly experienced Clinical Research Associates (CRAs/Monitors), Clinical Project Managers when and where you require.