Global project Management Services

/Global project Management Services
Global project Management Services Emmanuel Sanchez 2018-04-11T14:25:43+00:00

GLOBAL PROJECT MANAGEMENT SERVICES

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…

Sites selection

  • Feasibility/selection questionnaire elaboration
  • List of investigators
  • Selection calls and/or visits
  • Selection report
  • Contract management – Direction information

Monitoring activities

  • Site Initiation visits
  • Site Monitoring visits
  • Data quality control – remote monitoring
  • Data Entry Visit (TEC)
  • Data archiving
  • Site Close-Out visits

Project management

  • 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