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. We can assist with Notified Body selection and negotiations.

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.

CE marking and FDA submissions

We are well acquainted with CE-marking studies and FDA regulations and can assure that your study can be designed and controlled to meet the demands of Notified Bodies and FDA. Our strategic establishment in Europe with ISO9001-2008 certified Standard Operating Procedures that comply with ICH-GCP and ISO14155 (EN540) regulation will provide you great advantage.

Postmarketing Surveillance (PMS)

The transition from clinical development to marketplace introduction is critical to the success of a product. Post-marketing surveillance studies can give you the valuable information you need to optimize your product's potential and gain competitive advantage.

Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts. Factory is eager to work with you to achieve the scientific credibility of PMS studies and to maximize your product's exposure.

Monitoring

Our monitors/clinical research associates guarantee up to date knowledge of your trial status at each participating hospital. Our monitoring activities consist of:

• Pre-study & initiation visits
• Monitoring visits
• Source Document Verification
• Close out visits
• Trial document handling
• Reporting of safety information
• Administrative tasks

SAE/AE reporting

Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

Clinical monitoring

One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.