Strategic, Clinical & Regulatory Planning with Clinical Research by Deloitte

Find out how Clinical Research by Deloitte can be of assistance:

Preliminary project

In the pre-project phase, the necessary information for the project decision is gathered. In order to be as realistic as possible about the timing of market entry and profitability, this early phase includes the development of a regulatory and clinical strategy for the approval and maintenance of the product in the target markets. A reimbursement and sustainable growth strategy should also be considered.

Successful design validation based on well-defined user requirements and claims

In the event of a positive project decision, the user requirements, preliminary intended use, hazards and harms, and planned claims for the medical device to be developed are defined as the basis for further development steps. Please consider our Real World Data (RWD) service to support this step. A careful and forward-looking description of the user requirements and claims is key to efficient development, as it serves as the basis for specifying the design input and as the basis for design validation. While design verification shows whether the medical device has been developed correctly in relation to the design input, design validation shows whether the correct medical device has been developed. During design validation, the medical device is tested on patients by the end user against the user requirements and claims for the specified intended use.

Partnering with Deloitte

By working with Deloitte early on, we can help you develop a holistic regulatory and clinical strategy that accelerates market entry, supports sustainable growth, and reduces the cost of necessary pre- and post-market clinical trials. Our team assists you in developing a lean study design and understands local regulatory requirements, upcoming changes, and varying regional timelines for regulatory and ethical approval of clinical trials. With this knowledge, we can help you select the countries where you can start your clinical trial as early as possible, considering your target markets, reimbursement, and the importance of clinical evidence for your growth.

For more information please visit our Clinical Research overview website. Please feel free to contact us to discuss your specific needs.