Regulatory
The regulatory process is one of the first and most important steps in a Clinical Investigation Study. TRIQ can provide support for your Clinical Investigation Study with highly qualified and experienced experts to ensure that all regulatory timelines are met without delays. Each delay can have an impact to the clinical investigation timelines and will increase customer’s cost.
Regulatory Process
TRIQ will help it’s customers to understand the regulatory process from the submission to obtaining the required approvals according to the EU 2017/745 MDR, EN ISO 14155 and all applicable regulations, laws and guidelines. For a professional submission, it is most important to understand the approval process and local requirements of the Competent Authorities (CA) and the Ethics Committees/IRBs (EC) limiting the time to receive CA/EC approvals. Our experience and effective communication between the customer and the authorities, combined with excellent knowledge of relevant electronic portals, enables us to perform a timely submission.
Regulatory Services
TRIQ can provide for you an internal support or provide full-service support on your behalf:
- Feasibility and Assessment Process
- Review of Documents
- Clinical Evaluation Plan/Report
- Personal interaction with Competent Authority and Ethics Committee/IRB to verify submission requirements
- Preparation of the submission packages to Competent Authority and Ethics Committee/IRB
- Submission & Application to Competent Authority/or other Authorities
- Submission & Application to Ethics Committee/IRB
- Submission of Substantial/Non-Substantial Amendments to Competent Authority and Ethics Committee/IRB
- Personal interaction with Competent Authority and Ethics Committee/IRB to resolve queries and issues
- Submission of Annual Reports
- Listing of the trial and results on US and/or EU portals
Hospital Contract and Negotiation
TRIQ can provide clinical trial contract templates and assist in contract and budget negotiations with investigators & hospitals.