Consulting Services
In this highly dynamic and competitive business environment, it is important to have a partner that can help you successfully navigate through the complex drug development process. Whether your team needs assistance selecting the optimal modality for your protocol, advanced training on medical imaging best practices, or is considering strategic licensing of a novel compound – RadPharm can help!
Led by our tenured senior executives with extensive industry experience, RadPharm boasts unparalleled regulatory approval success and medical expertise in oncology drug development. We provide value-added strategic consultative solutions including:
 Protocol Review
- Charter Development
- Due Diligence
- Image Facility Qualification
- Radiation Dose Assessment/Medical Physics
- Training & Education
Protocol Review & Charter Development
RadPharm has an experienced team of Radiologists and Oncologists complemented by operational and technology luminaries who have been focused on accelerating the drug development process since 1993. To date, we have supported over 350 clinical trials including authoring the Independent Review Charters.
RadPharm’s industry-recognized physicians are available for consultation in the planning and implementation of the imaging portion of your protocol, including identification and selection of optimal response evaluation criteria and modalities for your study.
Due Diligence
RadPharm offers valuable medical due diligence based on imaging endpoints for Pharmaceutical, Biotechnology and Medical Device companies that are contemplating investments, strategic partnerships and mergers & acquisitions in the biopharmaceutical market space. These services are performed with sound industry understanding of the complete drug development process and associated challenges including time and budget constraints.
We offer a confidential, unbiased perspective to aid in your decision making process and ultimately, your compounds overall acceptance and long term success. RadPharm’s due diligence service enhances business decisions by combining a thorough understanding of technologies, logistics, radiographic interpretation and operational process with an ability to summarize complex issues into concise, easily understood terms.
We combine medical, operational and analytical skills that produce measurable results to support your discussions with senior management teams, vendors and other critical audiences. Our services range from initial evaluation to confirm claims of tumor response to detailed on-site due diligence visits, management consultation and in-depth training across all modalities.
Imaging Facility Qualification
To obtain the most robust data from acquired imaging examinations toward the assessment of a compounds efficacy, imaging facilities must adhere to appropriate regulatory and professional guidelines concerning equipment calibration, testing and maintenance. Image quality and associated data provided within the scope of a clinical trial are affected by imaging system characteristics such as spatial resolution, sensitivity, field-of-view size, spatial uniformity, stability over time, signal-to-noise ratio and, in the case of functional imaging such as PET or SPECT, radionuclide dose calibration.
In addition to these hardware-related challenges, the adequacy of software and imaging facility specific protocols for tomographic reconstruction, image storage and transmittal must also be considered. Additional issues to be addressed include: technical staff training and evidence for the implementation and documentation of routine quality control procedures.
RadPharm provides consultation and oversight in all these areas to optimize image quality in support of your drug development program through imaging facility qualification:
- Specification of imaging requirements
- Review of facility imaging capabilities
- Hardware/software assessment
- Quantitative phantom imaging
- Review of facility quality control program
- Protocol training
- Ongoing technical support
- Site visits and inspections
Radiation Dose Assessments
Institutional Review Boards and Radioactive Drug Research Committees, as well as subjects and their families, often require information concerning the radiation doses received during clinical trials.
RadPharm's Medical Physics Group can provide information concerning study-specific typical doses for the standard imaging procedures encountered in clinical trials. This information can be provided either during the study planning stage, to guide the selection and frequency of imaging procedures, or at any point during the trial.
Educational Seminars
At RadPharm, the on-time delivery of your clinical trial is our top priority. From project award and study start up, our experienced project management team works as a seamless extension of your internal team to ensure success. In addition to our standard project training, our Medical Affairs and Operational experts are available to provide supplemental educational seminars on oncology drug development, regulatory process and best practices for your team. With global experience supporting more oncology studies than any other imaging core lab (ICL), RadPharm is best qualified to educate your clinical trial staff on industry-wide standards and procedural guidelines in the use of medical imaging in drug development.
RadPharm’s broad range of experts, several of whom actively participate in key industry working groups and associations, will work with you to tailor a comprehensive training program for your team, comprising the following course modules:
- Introduction to Medical Imaging
- Monitoring Clinical Trials with Imaging Endpoints: Common Issues
- Radiographic Assessment of Bone Metastases
- Introduction to Molecular Imaging
- FDG-PET in Early Phase Oncology Trials: Quantitative Evaluation
- FDG-PET in Response Assessment: Lymphoma
- Radiographic Assessment of Tumor Response
- RECIST 1.0 to RECIST 1.1: A Summary of Changes
- Applications of the RECIST 1.1 Guidelines
- Independent Review for Oncology Clinical Trials: Lessons Learned
Our impressive faculty members are recognized industry key opinion leaders, physicians, and technological professionals committed to driving the advancement of clinical research through the application of proven processes and novel technologies in medical imaging management for clinical trials.
Faculty
- J. Michael O’Neal, MD, Chief Medical Officer
- Eric S. Perlman, MD, Chief Scientific Officer
- James Golando, VP, Clinical Operations
- George Edeburn, MD, Senior Director, Medical Affairs, Radiology
- Karolina Meurer, DVM, Managing Director, European Operations
- Kristin Borradaile, Associate Director, Business Integration
We invite you to empower your drug development team for success by scheduling a seminar today and effectively leveraging RadPharm’s medical and scientific expertise combined with a legacy of operational experience in the imaging sciences market sector.
To arrange a custom training program; contact your Business Development professional by calling 877.632.9432 or via email at seminars@radpharm.com.
|
