Medical Imaging

Biotrial’s extensive experience in medical imaging, going back to 1997, provides clients a range of valuable services. These include site selection and support services, as well as the centralized assessment and quality control of medical images obtained during clinical trials, through a customized process that is adapted to the needs of each trial and the specifications of each sponsor.

Our Core Lab provides precise quantitative and qualitative measures of imaging endpoints.

Biotrial-Corelab-medical-imaging

Our processes for image collection and analysis allow us to provide high quality data to support key clinical endpoints.

Expertise

Biotrial Core Lab Oncology Neurology Cardiology

Therapeutic Areas

  • Oncology: RECIST (i, ir, m, 1.1), Lugano, Cheson, RANO
  • Neurology: Multiple Sclerosis, Alzheimer’s Disease
  • Cardiovascular
  • Musculoskeletal Disorders
  • Gastrointestinal

Imaging Modalities

  • CT Scan
  • X-ray, DSA 
  • MRI, fMRI
  • PET Scan
  • SPECT
  • Ultrasound
  • Endoscopy

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

Adjudication

The need to implement and endpoint adjudication organization is assessed for each project. This depends on the type of endpoint considered as well as on regulatory expectations for the endpoint.

When adjudication is required, Biotrial can set up the needed organization, calling upon the needed number of readers to review each image and provide their conclusions, together with a reconciliation/adjudication step implemented by a senior, designated expert or through an agreement between the initial readers.

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Biotrial Core Lab Site Management

Site Management

  • Site evaluation and validation including a dummy run to ensure that each trial site follows the same process for image recording throughout the trial
  • Site training 
    • Image acquisition & transfer protocol
    • Patient preparation procedure
    • Protocol requirements
  • Support
    • Technical support and hotline
    • Specific user manuals (for preparation, acquisition & transfer)

Quality Assurance

  • Compliant & validated solutions (software validation policy): 21 CFR Part 11
  • SOPs describing each step of our process
  • Imaging server backed up daily
  • Secure web transfer tools for site image uploads

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