Project Management is performed in accordance with applicable regulations, ITEC Services standard operating procedures, study protocols and contracts.
The team is composed of a Project Manager, a Clinical Study Manager, Clinical Research Associates, a Pharmacovigilance Assistant, a Data Manager, a Statistician and a Medical Editor.
The Head of Department and the Quality Assurance Manager are also involved in planning and monitoring the activities and each project.
Our main feature: the stability of the team, its expertise and its involvement.
ITEC Services SAS can support the entire project or only a part, depending on the request.
Study management documents preparation
- Study Management Plan, including Quality Plan and Communication Plan
- Data Quality Control Plan / Monitoring Plan
- Safety Management Plan
- Investigator and hospital agreements
Investigator files preparation
- Trial Master File
- Site Master File (Investigator and Pharmacist)
Clinical Trial Management System (CTMS)
Selection and management of other research stakeholders :
- CDMO: IMP manufacturing and distribution, including importation
- Provider in management or storage of biological or clinical samples Translation
- Graphic designers, Printers…
- Feasibility/selection questionnaire elaboration
- List of investigators
- Selection calls and/or visits
- Selection report
- Contract management – Direction information
- Site Initiation visits
- Site Monitoring visits
- Data quality control – remote monitoring
- Data Entry Visit (TEC)
- Data archiving
- Site Close-Out visits
- Investigators meeting
- Team training
- Fees and hospital extra charge management
- Budget monitoring
- Communication with the promoter and stakeholders – Meetings and Conference call
- Progress report
Study Scientific Committee management
Independent Monitoring Committee management