Imaging


cerveaux, radio

Imaging Services

Following the development of communications technology in the past decade, the possibility to have an efficient and fast central overreading provided for medical imaging performed during clinical trials has appeared. Biotrial’s expertise in this field, going back to 1997, provides clients with a centralized assessment and quality control of the images following a tailored process adapted to each trial’s needs and each sponsor’s specifications.

Therapeutic Areas

  • Oncology: RECIST expertise
  • Neurology: Multiple Sclerosis, Alzheimer's Disease
  • Cardiovascular
  • Musculoskeletal Disorder

Imaging Modalities

  • CT Scan
  • X-ray, DSA 
  • MRI, MRA 
  • PET Scan
  • SPECT

This is a non-exhaustive list, please contact us for further information on our capabilities in imaging, our experts will work with you to identify the most adapted solution to your needs.

Imaging Project Management

Proactive Project Management with a high level of communication, teamwork and flexibility is the secret to a Biotrial study's success.

The Project Manager is focused on providing specialized services based on a well-designed project plan, allowing us to respect deadlines and to keep our sponsors up-to-date at every step of the project.

Site Management

  • Site evaluation and validation including a dummy run
     
  • Site training 
    • Image acquisition & transfer protocol
    • Patient preparation procedure
    • Protocol requirements
       
  • Support
    • Technical support and hotline
    • Specific user manuals (for preparation, acquisition, transfer,…)

Role of the Project Manager

  • Main contact between the sponsor, investigator site, radiologists, Data management, etc.
  • Setup (with sponsor) of the Image Review Charter (IRC)
  • Permanent contact with sponsor and investigator site
  • In charge of the schedule for:
    • Radiologist examination
    • Site evaluation
    • Data transfer to sponsor

Quality Assurance

  • Compliant & validated solutions (software validation policy): 21 CFR Part 11
  • Process covered by SOPs
  • Imaging server backed up daily

 For more information please contact us: contact@biotrial.com

Imaging Process & Assessment

Biotrial’s Core Lab provides precise quantitative measurements of imaging endpoints. Final measurement results are manually guided, inspected and certified by an expert.

Our standard process for image collection and analysis allows us to achieve high quality data characterized by low intra-reader variability.

Global Process

The global process, described below, consists in the succession of steps which respect procedures provided by Biotrial. The process is updated according to sponsor requirements and is compliant with all regulatory requirements.


For more information please contact us: contact@biotrial.com