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Regulatory Expertise
Engage CoreLab Partners for your drug development program and gain immediate access to an exceptional level of regulatory, medical, and scientific expertise. Founded and led by medical physicians and an experienced team of operational and technology luminaries, CoreLab Partners continues to accelerate drug development research, working in tandem with regulatory bodies and key clinical research associations to establish core lab industry standards.
 CoreLab Partners’ unmatched regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have an unprecedented number of successful, medical image data submissions on many high-profile drugs on the market today. Further, CoreLab Partners’ senior management has worked with the ICH and FDA to advance industry standards and guidances in the conduct of TQT studies.
Industry Associations
CoreLab Partners’ management has played a leadership role in developing industry-wide standards and procedural guidelines in the conduct of clinical research employing medical imaging, and cardiac safety and efficacy services.
CoreLab Partners’ 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 ongoing 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 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 and cardiac safety core labs
- Response Evaluation Criteria in Solid Tumors (RECIST) Committee that 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
- Cardiac Safety Research Consortium (CSRC), including participation in the development and writing of a consensus white paper focused on considerations related to off-target blood pressure effects as a cardiac safety endpoint
- ICH E14 expert advisory panel
Experience You Can Trust
 From protocol design through agency submission, you can rest easy knowing that with CoreLab Partners, your clinical trial is in the hands of cardiac safety and medical imaging experts, and compliant with well defined quality processes and regulatory standards.
CoreLab Partners regulatory services include:
- Protocol consultation and guidance throughout development life cycle
- Fast-tracked ECG and imaging data regulatory submissions and archiving
- Independent imaging review charters
- 21 CFR part 11 compliant systems, validated and integrated
- Image repository and documentation database(s)
Independent Review Charters
At CoreLab Partners, 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. To this end, CoreLab Partners has experience authoring more than 550 charters.With the Chief Medical Officer’s oversight, and according to our SOPs, each IRC is authored by a designated team of inhouse radiologists, medical writers, and project managers.
Our significant experience in charter development means effective trial conduct and preparedness for regulatory review.
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