Regulatory Expertise
Partner with RadPharm to progress your drug development program and gain immediate access to an exceptional level of regulatory and medical expertise. Founded by physicians, RadPharm is led by an experienced team of medical physicians and operational and technology luminaries whom, since 1993, have been accelerating clinical trials and working in tandem with regulatory bodies to establish Imaging Core Lab (ICL) standards.
RadPharm’s unmatched regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have an unprecedented number of successful oncology submissions of medical image data on many high-profile drugs on the market today.
 Unrivalled Relationships
RadPharm management holds a leadership role in developing industry-wide standards and
procedural guidelines for the use of medical imaging in the clinical trial process.
RadPharm’s contributions include interaction with the following:
- The FDA, PhRMA, DIA and Imaging Core Lab harmonization efforts as members of the Steering and Planning Committee and participation in on-going round table meetings
- FDA’s Charter Template, Site Interface and Best Practices task forces
- RSNA’s international steering committee for the Uniform Protocols for Imaging Clinical Trials (UPICT) effort
- Authoring of the UPICT (Uniform Protocols for Clinical Trials) charter template that served as a
standard template for Independent Review of imaging studies
- Metrics Champion Consortium (MCC) that developed metrics for evaluation of processes
used by Imaging Core Labs
- Response Evaluation Criteria in Solid Tumors (RECIST) Committee that recently authored
updated guidelines
- PhRMA Progression Free Survival (PFS) Working Group
- Radiologic Society of North America (RSNA) Qualitative Imaging Biomarker Alliance (QIBA)
effort including representatives on the FDG-PET, Volume CT and DCE-MRI Working Groups.
- RSNA CTSA Working Groups
- Extended PhRMA Imaging Group
Experience You Can Trust
From protocol design through regulatory submission, you can rest easy knowing that with RadPharm, the medical imaging portion of your clinical trial is in expert hands and compliant with well defined quality processes and regulatory standards. RadPharm regulatory services include:
- Protocol consultation and guidance
- Independent Imaging Review Charters
- 'Fast-Track' regulatory submissions
- 21 CFR part 11 compliant systems, validated and integrated
- Image repository and documentation database(s)
Independent Review Charters (IRCs)
 At RadPharm, we believe the imaging portion of every trial should have clearly defined standards and processes outlined in accordance with regulatory agencies, the study protocol and sponsor objectives. RadPharm has authored over 350 charters - one for every study we’ve supported! With the Chief Medical Officer’s oversight, and according to our SOPs, each IRC is authored by a designated team of in-house radiologists, medical writers and project managers.
Our significant experience in Charter Development means effective trial conduct and preparedness for regulatory review.
 Regulatory Guidance
As a leading ICL, RadPharm leverages our medical and regulatory leadership to ensure the success of your drug and medical device development program. Our regulatory experts work closely with you and the regulatory agencies to drive efficiencies and ensure both protocol and regulatory compliance.
Technology and Processes
RadPharm’s image-handling, measurement and storage systems are fully integrated, validated and 21 CFR part 11 compliant. RadPharm strictly adheres to GCP, ICH and other applicable GXP guidelines.
 Submission and Archiving
Our understanding of regulatory requirements is second to none. We have a strong legacy and positive working relationship with the global regulatory agencies. Our clinical data submission processes mirror agency guidelines, ensuring successful, fast-tracked submissions. |
