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 ABPM technology for your protocol, advanced training on medical imaging best practices, or is ready to conduct your company’s first global TQT study—CoreLab Partners can help.
Led by our tenured senior executives with extensive clinical research experience, CoreLab Partners boasts unparalleled regulatory approval success and cancer drug development experience. Additionally, CoreLab Partners’ global cardiac safety and efficacy regulatory expertise is second to none, having successfully completed the first ever regulatory mandated TQT study in the Asia Pacific Rim and the first TQT study for a Japanese new drug application (NDA).
CoreLab Partners’ key opinion leaders (KOL) are available for consult on clinical and regulatory strategy to meet objectives within the framework of your development program and specific compound. What’s more, we are uniquely capable of providing advanced know-how in addressing blood pressure as a cardiac safety endpoint as well as specific cardiac safety challenges found in oncology drug development.
We provide value-added, strategic consultative solutions including:
- Cardiac safety analysis & expert reporting
- Protocol development & study design
- Regulatory guidance & support
- Charter development
- Image facility qualification
- Radiation dose assessment/medical physics
- Training & education
Cardiac Safety Analysis and Expert Reporting
CoreLab Partners recognizes the need to provide comprehensive services from study design, to study conduct and expert reporting on a study’s cardiac safety data. We possess strong capabilities in analyzing and presenting ECG/ABPM/CV data in regulatory, expert-report format, and we support regulatory meetings and presentations. Our statistical and medical writing team has authored more than 250 expert reports, most of which supported regulatory submissions and full TQT protocol development.
Protocol Development and Study Design
CoreLab Partners’ team of radiologists, oncologists, cardiologists, and nuclear medicine physicists is complemented by experienced operational and technology professionals who have been focused on accelerating the drug development process since 1985. To ensure receipt of credible, mission-critical study data, engage our team of experts early to assist in developing an effective, comprehensive drug development program and trial protocol.
CoreLab Partners has worked closely with the FDA in the development and advancement of the TQT study design and is poised to assist in your study’s design.
Imaging Facility Qualification
Image quality and associated data, provided within the scope of a clinical trial, can be affected by characteristic flaws of both the imaging system and software. Therefore, to ensure credible data is acquired during imaging examinations, CoreLab Partners qualifies partner imaging sites, confirming the sites’ adherence to all appropriate regulatory and professional guidelines concerning equipment calibration, testing, and maintenance.
CoreLab Partners provides consultation and oversight in all key areas to optimize image quality in support of your drug development program through imaging facility qualification:
Radiation Dose Assessments
- 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
IRBs and RDRCs, as well as subjects and their families, often require information concerning the radiation doses received during clinical trials. CoreLab Partners’ 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.
Training and Education
At CoreLab Partners, your clinical trial is our top priority. From project award, our experienced project management team works as an extension of your own internal team to ensure trial success In addition to our standard project training, our medical affairs experts are available to provide your team supplemental training modules on regulatory processes, best practices, and oncology drug development including QT assessment. Additionally, we will provide all training at a convenient location and time of your choosing.
To arrange a custom training program for your team; contact your Business Development professional by calling 877.632.9432 or via email at email@example.com.