Clinical Trials in Europe

Today European regulations for clinical trials allow a fast start of the clinical investigations. Consequently more and more US companies are planning to start clinical trials in Europe and the US in parallel.
Our comprehensive Clinical Trials Services will assure that your clinical trials will meet all provisions of EU requirements. From planning to study conduct, from Authorized Representative Service to study reporting, we provide expert study planning and management. By our in-depth knowledge of international GCP regulations you are assured that the clinical studies meet the highest quality standards while maintaining cost effectiveness and maximum efficiency.

Clinical Trial Services include:


Regulatory services for Clinical Trials

	Cooperation with ethical committees & IRB
	Study Notification
	Vigilance Notification

Planning phase

	Study design according to EN 540 (for Medical Device trials)
	Development of study protocol
	Preparation of CRF
	Writing of investigators manual
	Cooperation with ethical committees & IRB

Study performance in cooperation with qualified partner organisations in different European countries

	Initiation visits
	Investigation Qualification
	Monitoring

Biostatistics in cooperation with qualified partner organisations in different European countries

	Data Management
	Data Base design, data QC and verification

Quality Assurance

	Audits
	Design and implementation of GCP Compliance Programs

Study Reporting

For studies with medicinal products our Legal Representative Services provides assurance for study compliance with the Directive 2001/20/EC.