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Bulgaria, Sofia

Medical Services in Bulgaria

Medical Services in Bulgaria offered from Univercity Medical Research in Bulgaria are Regulatory Affairs, Feasibility, Clinical monitoring, Project Managment, Drug hadling.

Regulatory affairs

Our regulatory activities include regulatory submissions of applications for approval of clinical studies as well as submissions of SAE and SUSAR reports as per the local requirements. By having the knowledge of the local laws and regulations on clinical studies UniMR is able to streamline the regulatory approval process in the shortest time possible. We also provide certified translation of regulatory documents.

Feasibility

We have very good professional contacts with the leading Investigators and Physicians in nearly all therapeutic areas. This gives us the opportunity to perform reliable feasibility and to provide important information to our clients.

Clinical monitoring

Monitoring activities include pre-study site identification, study initiation, monitoring, drug accountability and site closure. Our monitors are physicians trained in ICH-GCP and EU and local requirements with very good spoken and written English. These factors as well as 100% source data verification ensure high professional standarts and superior data quality. Co-monitoring visits performed by our Quality assurance manager and project managers additionally contribute to the highest level of GCP and protocol compliance.

Project management

UniMR understands that effective project management and communication are key factors to the success of any clinical trial. Our project teams consist of project manager, clinical monitor, project assistant and regulatory and drug safety associate. Project team meetings are held regularly to ensure good communication between the team members. UniMR project managers are experienced in utilizing project management tools to deliver the project goals.

Drug handling

We provide customs clearance, distribution, shipment, and destruction of study drugs. Our storage facilities are well equipped for proper storage of investigational products.

Other services

Training of Investigators including ICH-GCP training

Delivery of dry ice