The requirements for clinical studies are increasing and it is important that all sponsors understand how to utilize their clinical resource. This includes deciding on how and when you should outsource. Also, looking at the methodologies currently available that will enable you to select the best partner. Also, there is a need for clinical evaluations for medical device products on the Europe market. This is now an essential requirement for all devices registered under the Medical Device Directive.
When selecting a CRO for your clinical studies it is important to note:
- The medical device clinical research market is set for a rapid expansion
- The market is currently estimated at $3.5b(2012)
- It is expected to grow to $7.2b in the next 6 years
- How should Medical device manufacturers prepare for this rise in requirements
- How to weight up the benefits between insourcing and outsourcing
- The new regulation will possibly be adopted and published within the following 12 months with implementation from 2015 to 2018. What is the impact on device studies in Europe?
- What methodologies are currently available to manufacturers and how should they be utilized for maximum impact.
To learn more about selecting a CRO for your clinical studies or what you need in a clinical evaluation, you can contact our Clinical experts and set up a consultation. You can also meet with our experts at the Clinical Operations and Outsourcing in Medical Device Trials Europe 2015 in Munich on February 10-11, 2015. If you would like to set up a meeting, please contact us.
You can also learn more about our clinical services.