Factory-CRO specializes in the complete management of clinical studies for medical devices, biologicals, and drug-device combinations. From determining where and how to start your clinical trial, to identifying the most influential KOL’s across Europe, Factory’s expertise will help you run the most efficient and cost-effective study possible.
The key to success in conducting a clinical trial is to have all the necessary information needed at hand. Factory-CRO can ensure you will obtain this information. Our therapeutic and surgical expertise gained through twenty years of experience assures you receive accurate, thorough and valuable information.
Protocol / Study Design
Our extensive experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout Europe.
European Regulatory Strategy
In many cases it is easier, faster and cheaper to obtain your CE mark (which provides marketing approval for Europe) than an FDA approval. And in most cases, equivalent clinical studies are less expensive in Europe than in the USA.
Many of our clients have exploited these two advantages in order to begin marketing their product in Europe prior to FDA submission. Further, Factory can often help clients conduct European studies which accelerate FDA submissions.
We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation.
Timelines and Budgetary Control
Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.
