Medical Device Preclinical and Clinical Trial Project Management
Aptiv Solutions has assisted hundreds of clients with preclinical and clinical trial project management. After initial design and prototype activities, and as your project proceeds, you will begin to conduct pre-clinical tests and clinical trials and collect appropriate data to support your study endpoints. Our regulatory and clinical trial professionals can help you to ensure that the appropriate testing is conducted and that your study data is presented in the most appropriate formats for the regulatory agencies and others who will pass judgment on your new product.
Throughout the course of your medical device clinical study, our project managers will oversee day-to-day study activities, giving you confidence that all the relevant data are captured, collected, and interpreted to support your study goals. Your project manager will assist the clinical sites with submissions to the appropriate Institutional Review Boards (IRBs), Ethics Committees, and the FDA and international regulatory bodies to facilitate the approval process, provide routine reporting on study progress to keep you apprised of data accrual and data quality on a site-by-site basis, and keep you and your study team on track with regular communication.
We will work with you to:
- Define appropriate pre-clinical and bench studies
- Develop a clinical trial design, prepare study protocols and study documents
- Identify study sites
- Obtain regulatory / IRB / Ethics Committee (EC) approvals
- Collect, manage, and monitor clinical trial data
- Perform statistical analysis
- Prepare clinical study report
- Further design and implement your quality system to meet FDA, QSR and ISO 13485 requirements