OPIS - Clinical trials

EDC / eCRF

Authorized users

	Events

Bio-availability studies, Bioequivalence studies, clinical trials phase II-IV, Pharmacoepidemiology studies, observational studies

The management of clinical trials is carried out while ensuring maximum flexibility towards our Customers’ needs, in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (internal or supplied by the Customers).

		Trial organization and planning
		Definition of: objectives, patient selection criteria, sample size, experimental design.

		Investigational sites selection
		The experience gained in years of activity has enabled us to achieve a sound knowledge of Investigational Centres, useful in their selection on the basis of criteria such as: quality, productivity, equipment owned.

		Ethics Committee application
		Through the centralized Trial Start Up unit, we guarantee maximum efficiency in the management of pre-trial activities. The centralization of activities enables us to obtain better specialization and knowledge of the organizations and of the operating needs of the different actors involved, in addition to developing specific competence in the field of Italian regulation.

		Management of financial and administrative relations with Investigational Sites
		Contacts with hospital/university Administrations up to the signature of the economic agreement.

		Investigators’ meeting
		Preparation of presentations (traditional and multi-medial visuals) from a scientific, editorial and operating point of view.

		Monitoring
		It is carried out throughout the whole trial and includes: initiation visits, monitoring visits, data verification (SDV 100%), drug accountability, close out visits. Through the planning activity, the trial progress is constantly analysed in order to detect possible critical elements and to take the relevant corrective actions.

		Documentation service
		The Documentation Service prepares the Trial Master File (TMF) and the Investigator Folder (IF), which contain all the study documentation constantly updated.

		Integrated clinical-statistical study report
		The final report is written in compliance with ICH (International Conference on Harmonization) guidelines.

		Quality assurance
		Quality is ensured through the control of all research activities, which must be in compliance with GCP and SOPs, and through the check of the adequacy of all the documents produced. The Quality Management System is Certified ISO 9001:2000.