Clinical Trial Management

Empirical Clinical Solutions provides support for the design, planning and implementation of clinical investigations. When it comes to clinical trials, preparation is key. A successful clinical study program will consider feasibility, trial design, safety and performance, post market clinical follow-up and how the trial will achieve quality standards and address the needs of regulators. It is also important to thoroughly understand the total costs involved with your clinical trial and meeting the EU MDR 2017/745 requirements. Empirical Clinical Solutions can assist in preparing and monitoring your clinical trial, including recruiting the right patients, obtaining informed consent, complying with protocol and overseeing the allocation of devices for full traceability and transparency.

Our support includes:

• planning and design of the clinical investigation
• management of clinical trial timelines and budget
• preparation of critical documents including clinical protocol, patient information and consent forms, investigator brochure, and other essential documents in alignment with relevant standards including ISO 14155:2020
• ethical and regulatory submissions and follow-up
• clinical project management, monitoring and preparation for audit/inspection
• training for ISO 14155:2020 GCP Medical Devices and EU MDR 2017/745
• access to a network of experts in all functional areas of clinical research

To find out more about how we can support your clinical trial, please get in touch.