A Clinical Strategy helps you determine the most efficient and effective path to completing your clinical trials and supporting your value propositions. Click Here for a breakdown of the clinical strategy process.
CTIP's resources will help you to define a clinical strategy that takes into account the required regulatory pathway for the device, the market, and the competitive and reimbursement landscape in which the device will be offered. This includes defining your top value propositions, receiving advice from experts on the proposed studies and determining what data will be required to make your value propositions compelling to your target audience, and ensuring that your study strategy is cost-effective.
CTIP Clinical Resources
USC Keck School of Medicine - Keck is one of the largest teaching hospitals in the nation, is home to 25 research-oriented basic and clinical academic departments. The Department of Pediatrics centered at CHLA, with 528 medical staff members and approximately 244 physicians, is Keck's largest academic department. With annual research funding in excess of $160M, Keck provides expertise in all areas of direct pediatric patient care and access to pediatric patients for clinical trials.
Southern California’s Clinical and Translational Science Institute (SC CTSI): Center for Clinical Translation - The Center includes state-of-the-art space for the conduct of early phase (drug development) and complex mechanistic trials, outpatient and inpatient research space, trained staff, design and feasibility consultation meetings involving representation from CTU staff, clinical research expert(s), biostatistics, protocol development, and many other resources.
Other Clinical Resources
- Investigational Device Exemptions 21 CFR 812 – Covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
- Protection of Human Subjects 21 CFR 50 – Provides the requirements and general elements of informed consent.
- Institutional Review Boards 21 CFR 56 – Covers the procedures and responsibilities for IRBs that approve clinical investigations protocols.
- Financial Disclosure by Clinical Investigators 21 CFR 54 – Covers the disclosure of financial compensation to clinical investigators, which is part of the FDA’s assessment of the reliability of the clinical data.
- Design Controls of the Quality System Regulation 21 CFR 820 Subpart C – Provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.
- Medical Device Foreign Regulations at Export.gov – Provides up-to-date regulations in selected foreign countries.
- FDA’s Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials – Guidance on developing a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the U.S. and abroad for certain FDA regulated products.