For bio-pharmaceutical and medical device manufacturers: - Support development of the imaging program from pre-clinical phases and translation into clinical studies.
- Radiology input into clinical trial design, development of study design concept and building business case for use of medical imaging endpoints.
- Scientific review of current state-of-the-art in imaging modality, methodology and imaging end-point assessment.
- Support radiology protocol development, review of radiology site documents and site training packages.
- Developing the regulatory package for imaging clinical trials including Special Protocol Assessment (SPA).
For hospitals and radiology centers: - Technical and
operational support for integration of research oriented medical imaging
processes into clinical imaging routines
- Development of
SOPs for compliance with GCP, ICH, HIPAA and regulatory requirements for
imaging clinical trials
- Training for
radiologists for Response Evaluation Criteria such as RECIST and other imaging
endpoints such as Joint space narrowing, Coronary artery calcification etc.,
- On-site
radiology or technician resource on a consulting basis
- Digitization of
radiology archives
For pathology labs: - Digitization
and storage of pathology images to support virtual microscopy
| BMI general consultancy services
We provide for clinical imaging and imaging IT infrastructure
development within academia, healthcare and the biopharmaceutical industry
BMI product specific consultancy services
- Project management
- Data Standards development
- Client specific customizations
- Data migration services
- Training
- Workflow integration
General consultancy services
- Business Case development
- Business requirement gathering and assessment (incl. URS)
- Cost/Benefit analysis
- Risk management
- Business process mapping and workflow development
- Market analysis and vendor assessment
- Technical evaluation of vendors and solution proposals
- Project management
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