Specific arrangements for the provision of services in clinical trials, the International Conference on Harmonisation of Good Clinical Practice for Registration of Pharmaceuticals for Human Use (ICH-GCP) defines a research unit (CRO) as: “A person or organization (character commercial, academic, or other) contracted by the sponsor to perform one or more of the tasks and functions related to the sponsor’s clinical research site. ”

(5.2.1) A sponsor may transfer one or all of their functions and duties related to its clinical trials to a CRO, but the ultimate responsibility for the quality and integrity of research data is always the sponsor. The CRO should implement a system of quality assurance processes and quality control.
(5.2.2) Any debt related processes and functions that are transferred to and assumed by a CRO should be specified in writing.
(5.2.3) Any charges related processes and functions not specifically transferred to be assumed by a CRO are retained by the sponsor.
(5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the tasks processes and functions related to a sponsor.

PROCALVIE-CRO provides expressly management activities, tracking compliance with the trial protocol and clinical support for drug and/or medical devices in various stages of research. The multitude of CRO-s are in this area range from large organizations, international full service CRO sites to small groups of specialized niche. PROCALVIE-CRO is an example of this type that easily modes itself to customers needs.

PROCALVIE-CRO is specialized in clinical study management services and offers their clients the expertise to pass a new drug or device from conception to marketing approval. The sponsor is not forced to maintain staff for these services or for certain periods of time when their workload is extended to specific projects. We are one of the clinical research organizations that provides flexibility, mobility and “hands-on” activities to its customers.

PROCALVIE-CRO is providing quality life clinical trials services following all the regulations, local and international, and has links with up to 150 investigators located in up to 15 sites in different areas of medical expertise.