Medical Department

EDC / eCRF

Authorized users

	Events

The Medical Direction, managed by Laura Ambrosoli, is the historical core of the company, even through it has been widely developed in years.
Today, thanks to the structure organized in “skill teams”, OPIS Group’s Medical Direction is able to offer the Sponsor a range of services covering every need in the process of clinical trial development, ensuring maximum efficacy and efficiency.

The different organizational functions, entirely focused on their specific service and co-ordinated so that the required interactivity and synergy are achieved, allow maximum specialization of the operating areas, thus consolidating the specific expertise: legacy that OPIS makes available to the Sponsor.

		Trial Start Up
		The Trial Start Up (TSU) service is in charge of the whole regulatory part and of the pre-trial activities relevant to clinical studies. The Service’s main activities are: Contacts with Ethics Committee, Managing Directions of Hospitals and Universities Management of documentation/notification to OsSC (Osservatorio Nazionale Sperimentazione Clinica – National Clinical Experimentation Observatory), which OPIS offers as additional service to the Sponsors that require it. The decision to create a centralized TSU office was generated by the need to obtain deeper specialization and knowledge of the organizations and by the operating needs of the different actors involved in the pre-trial stage, besides the need to achieve specific competences in the field of Italian regulations. After five years of centralized organization of TSU activities, OPIS can count on a background of knowledge and experiences valuable for efficient management of all the regulatory activities that the Group makes available to its Customers. The advantages of being able to count on a centralized TSU office are: deeper knowledge of internal rules/procedures of the different Ethics Committees, which allows higher operating efficiency, saving time and a higher possibility to obtain approval higher specialization on the Italian regulation field higher control on the progress of the application by the CRO, and consequently by the Sponsor
		Documentation
		The Documentation Service has the function of: preparing and regularly updating the Trial Master File preparing the Investigator Folders seeing to sending the necessary documentation along the whole study operating process The advantages of being able to count on a centralized Documentation office are: higher efficiency of the activities, in particular with reference to quality and timing central archive always updated
		Pharmacovigilance
		During clinical trial management, we pay the greatest attention to the patients’ health and safety, in addition to complying to the regulations in force. Through our pharmacovigilance service, we are in a position to ensure timely and accurate reports to the Sponsor, concerning the occurrence of serious adverse events (AEs). On the Sponsor’s demand, we can also guarantee total management of adverse events, SAE Query Forms and SUSARs, in compliance with the relevant regulations and SOPs.
		Clinical Operation
		The Clinical Operation staff is the core of the whole research activity. The supervision of clinical pre- and post marketing trials always takes place in compliance with the specific protocols, the company and Sponsor’s SOPs, the Good Clinical Practice principles and all the applicable regulations. The CRAs our staff consists of are co-ordinated by Clinical Project Managers, who see to their training on field during the insertion stage, and to their continuous training during everyday activities. The CRAs’ structure, also thanks to the Medical Direction organization divided into “skill areas” and thanks to the presence of staff services such as TSU, Documentation and Pharmacovigilance service, is totally focused on the monitoring activity, thus being able to concentrate entirely on two key objectives: PERFORMANCE: our CRAs are trained to meet the Centre and Sponsor’s needs also as regards studies involving highly specialist Therapeutic Areas (such as oncology-rare tumors, immunology-transplants), guaranteeing compliance with time agreement and cost optimization. The CRAs’ performances are constantly monitored by means of measuring systems (KPI). QUALITY: our CRAs’ quality and reliability are ensured by both the strict recruitment criteria, described in detail in the SOPs, and training and refresher programmes organized internally and/or externally.