One of the most important tasks in the start-up of a clinical study is the submission to ethics committees and the notification of competent authorities Our excellent relationship with these instances and other independent committees such as radiation committees has enabled us to help clients start rapidly with their clinical trials in Europe.
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 ISO9001-2000 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. Postmarketing 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.
