Clinical studies are considered to be the highlight of the medical world and have great influence on treatment and determining health policies. In most cases they are initiated and funded by medicinal or pharmaceutical device companies.

These standards enable you to:
– Maintain the rights and safety of the participants of the study
– Assure the credibility and accuracy of the data and the reported results
– Comply with strict regulatory requirements

Healthcare companies, especially those conducting international, multi- centered clinical studies, are compelled to deal with a number of challenges during the clinical study. This is especially the case if the results of the studies will be part of the registration file submitted to the FDA in the USA, the EMA in Europe and/or the country Health Authorities.

Amongst these challenges are choosing a CRO and CRAs that are to ensure that: the study will be of high quality according to the requirements of the health authorities while maintaining the rights of the participants/patients and choosing investigators experienced in conducting clinical studies according to the GCP. One of the keys for complete compliance of the study protocol is regularly developing and maintaining the professional knowledge of the staff conducting the study in the hospital and the community in order to confirm that the study is conducted properly according to the local GCP guidelines.

During the process of conducting a medical study, monitoring suppliers and service providers is required. During the process of conducting a medical study, close coordination between the initiator, the investigator and his staff, and the patients is required. Monitoring, reporting and documenting side effects and any other safety information are the basis of every clinical study and requires deep familiarity with the requirements of the health authorities.

Our professionals apply their therapeutic, regulatory and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements. Our international Clinical services include:
– protocol development
– Site and investigator identification and qualification
– Site initiation and training
– Clinical monitoring
– Medical monitoring
– Statistical analysis
– Electronic data capture
– Electronic Trial master file
– Full-Service data management
– registration in Local government clinical registry
– Central lab oversight and coordination
– Site quality assurance audit
– Integrated final clinical study report

Barrco Regulatory Solutions supplies international standards of quality starting from the planning of the study, throughout its implementation and up to its conclusion. We act according to international standards of the Good Clinical Practice (GCP) principles during the planning, management, execution, monitoring, control, registration, analysis and reporting of clinical studies.