Clinical Investigation Plan (CIP)/Bench Test Plan for SaMD designed with the support of Clinical Research by Deloitte
Deloitte supports navigating the complex terrain of regulatory compliance for product approval and post-market surveillance
The Deloitte Clinical Research team can proactively help you develop effective and efficient clinical investigation and bench test plans for medical devices and software, with the aim of minimizing your clinical costs while maximizing commercial success
Following a systematic approach, Clinical Research by Deloitte (CRO) supports the creation of the Clinical Investigation Plan (CIP) or Bench Test Plan for SaMD:
The CIP is the central document of a medical device clinical trial. All other documents for the authorisation and implementation of the clinical investigation are based on the CIP. A precise and structured description of the study, in accordance with the regulatory requirements, supports the investigators and the clinical study team in the successful conduct of the study. It also contains all information for non-clinical stakeholders, such as project managers, data managers, clinical research associates, biostatisticians, medical advisors and medical writers. Therefore, the CIP has a key role from study preparation to close-out.
As part of the world's largest life sciences consultancy, we have experience in key therapeutic areas. Our team combines deep subject matter expertise and robust processes to help our clients to develop, manage, and execute their clinical plans throughout the product lifecycle. Clinical Research by Deloitte has implemented a Quality Management Handbook (QMH) according to ISO 13485 fulfilling the requirements of ISO 14155 and GCP.
For more information, please visit our Clinical Research overview website. Please feel free to contact us to discuss your specific needs.
