Services

The key to success in conducting a clinical trial is to have all the necessary information needed at hand. Bielderman will ensure your obtaining this information. Our therapeutic and surgical expertise coupled with 17 years of experience enables us to provide our clients with accurate, extensive and valuable ‘experienced’ information.

Protocol/Study design

Our extensive experience and practical knowledge can help you set up a suitable study design to ensure that you get the right answer to your questions and meet the right objectives.
We organize regular meetings with panels of clinical experts in order to ensure that you are heading the right way with the design of your device and/or setup of your study.

European regulatory strategy

In many cases it is easier, faster and cheaper to obtain a CE mark (marketing approval for Europe) than an FDA 510k approval (Food & Drug Administration). Clinical studies are, without sacrificing quality, less expensive in Europe.
Many companies employ the strategy of obtaining European approval first, marketing their product in Europe and then proceeding with FDA 510k submission.
Bielderman offers a free, no-obligation consultation about your European Regulatory Strategy.

Timelines and budgetary control

Control of time and budget is essential for a company that wants to bring a medical device on the market. Our control system will give you all the information you need to keep you informed and stay in control.