Project Strategy


Our device for Patient Trial Management is to have efficient national and international working practices, rigorous quality standards as well as keeping to deadlines and budget terms in order to meet your specific project needs.

  • One-site Organization:
    • Centralization of all data
    • Easy and fast communication
    • Established processes & working groups
    • In-house Medical Experts, CRAs & CTMs   
       
  • One unique contact: the Project Manager
    • Regularly in contact with all local CRAs
    • Immediately forward/update the sponsor with new information 
    • Information of local CRAs concerning sponsor issues and decisions 

Patient Project Management

A proactive Project Management with a high level of communication, teamwork and flexibility is the key factor to the success of any study project.

Our Project Management is focused on providing specific services based on a well-designed project plan which allows us to respect the deadlines and to keep our Sponsors up-to date at every step of the project.

Monitoring

  • Pre-study and initiation visits
  • Monitoring visits 
  • Source document verification
  • Close-out visit after the Data Base Lock
  • Trial document handling
  • Management of SAE reports (initial and follow-up)

Regulatory Submission

  • Translation of Clinical Study Documentation
    • Translation into local language & back translation
    • Certification by an on oath translator if required
       
  • Submissions to European Regulatory Authorities
    • Preparation of CTA documents
    • Management of potential questions raised by the Local Regulatory Authorities
    • Management of  amendments/communication with the Local Regulatory Authorities in collaboration with the Sponsor
  • Regulatory Site Notifications and Document Collection
    • Preparation and management of  IEC/IRB submissions
    • Management of potential questions raised by the IEC/IRB, site-specific amendments to the generic informed consent
    • Assistance of Investigators to inform their IEC/IRB (Annual reports, SAE reports and end of study letter).

SMO Support

We can assist sites and provide them with our study Nurses, Technicians, etc.

Please click here to consult our ECG & Imaging Core Lab services.

For more information on our Phase II-IV services please contact us: contact@biotrial.com