Project Management Medical Devices
As medical technology continues to advance and product development becomes more complex, consulting can offer a number of strategic benefits. By avoiding the need to hire additional in-house staff or purchase costly data management software, and by leveraging knowledge of clinical trial requirements, you can realize significant cost-savings and often a faster, more efficient path to market.
Having experience as a Clinical Project Leader in EMEA and globally, LyncoClinical is able to support you through all phases of clinical trials to fit your product development program.
At any one time we can be involved in the design, management, and monitoring of medical device studies, representing varied technologies. Medical device clinical trials are one of the key focuses of our business.
Working with your team, we will help you to design and implement a clinical trial that will best meet your business needs, whether you need clinical data to support a CE-mark, regulatory pre-market submission, drive product adoption, support product reimbursement, or monitor post-market product use.
Examples (non exhaustive list):
- Protocol writing & refining
- Site selection
- (e-) CRF development
- Monitoring and co-monitoring sites
- Site training
- Vendor management (including setting up service specifications, budget tracking and implementation throughout the study)
- Management (interim) Data-cleaning activities
- Descriptive Data-analysis
- Report writing