Consulting Services
RadMD provides a unique consultative approach to implementing medical imaging endpoints in clinical trials.  We believe a thorough understanding of the therapy involved, along with cost, time, and resource issues, is necessary prior to providing meaningful advice on:

  • Defining and developing imaging strategies in a clinical development program
  • Imaging protocol development
    • Optimizing imaging endpoints
    • Developing site and independent image review strategies
    • Independent Review Charter (IRC) development
  • Imaging site selection and qualification
  • Site and blinded reader training through BRITI
  • Regulatory meeting attendance (pre-IND, pre-NDA, SPA, etc.)
  • Preparation and review of study and expert reports
  • Regulatory submission support
  • Expert and consensus panel development and participation

Our expertise lies in our ability to construct and implement customized medical imaging solutions to enhance the use of medical imaging in a clinical trial.

We also provide full service Imaging Diagnostics Clinical Development, from pre-clinical to NDA submission and post-marketing support, including Imaging Medical Affairs and Medical Marketing. With our combined experiences in clinical development, medical affairs and commercial operations we are uniquely positioned as the Imaging experts, and are the only organization that can provide the following:

  • Total Diagnostic Drug Development Strategy
    • Clinical Trial Design
    • Site Selection
    • Complete Study Operations
    • Preclinical program with customized imaging analytics
    • Toxicology - PK and PD
    • Full Radio-labeling Tracer Capabilities
    • CMC Consultation
    • Global Regulatory Strategy and Support - FDA, EMA etc.
    • IND, NDA and CTD Submissions

      • Complete Medical Affairs and Commercial Development
        • Review of clinical trial data and images
        • Data mining of imaging data for safety and efficacy signals
        • Develop imaging-enabled regulatory compliant marketing materials
        • Support Medical, Legal, Regulatory reviews and Grants Committees
        • Overall Regulatory support and strategy
        • Key customer support through facilitation of events within key accounts
        • Manage and run Advisory Meetings, Expert Panels and Focus Groups
        • Provide commercial input into development teams - NCE and LCM programs
        • Speaker forum support - supplying speakers and speaker training
        • Scientific training of Sales Consultants and Scientific Affairs
        • Medical Education programs
        • Complete Commercial Package Creation and Development for: Sales Force, Training, Marketing
        • Identify potential development or co-marketing partners

Blinded Reader Sourcing
RadMD is the global source for expert physicians to perform independent image reviews  - both safety and efficacy - from clinical trials (blinded reads).  Turn-key management of readers (contracts, training, logistics, performance monitoring, retraining, etc.) allows sponsors to focus on key competencies, increasing overall efficiency of the blinded read process, saving time and cost.

Over 600 experts include:

  • Radiologists
  • Oncologists
  • Cardiologists
  • Pathologists
  • Medical imaging physicists

24 hour read turnaround time is available for:

  • Subject enrollment/inclusion reads
  • Confirmation of disease progression reads

All RadMD readers are trained and tested through BRITI.

Demand for qualified radiologists and other physicians to participate as blinded readers has increased due to greater use of imaging in trials, leading to difficulties in identifying readers with expertise specific to a trial disease process or therapy.

RadMD has recognized this problem and has developed a worldwide database of board certified, highly qualified physicians in our  unique SMaRT™ database that includes pertinent professional information about each physicians including his/her education and qualifications; clinical and research experience; area(s) of expertise; prior participation in clinical trials and blinded reads; and other relevant information required by regulatory authorities and sponsors . SMaRT™ is a global resource, and includes physicians in North and South America, Europe, and Asia.

It is the extent and depth of our database of expert radiologists which allows us to readily identify and match physicians whose qualifications are optimal for performing a particular blinded read.

  • Worldwide extensive database of qualified radiologists
  • Readers in US, Central and South America, Europe and Asia allows for maximal global flexibility in the reading
  • Provides key separation of  sponsors and ICRO’s from direct hiring of blinded readers, minimizing potential bias.
  • Ensure the availability of radiologists within project time frame
  • Rigid standards for reader selection
Standardized training is a regulatory requirement, and BRITI (The Blinded Reader and Investigator Training Institute) is the first and global leader in education and training on medical imaging in clinical trials. BRITI provides training for blinded readers, imaging site investigators, clinicians, CRA's, project managers and others involved in image evaluation from clinical trials.
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