Services

Project Management team from CTC handles each clinical trial as being unique and therefore it is treated with high level of professionalism and confidentiality. In order to ensure success, efficiency and accuracy of data from the process of project management, each project manager is in close relation with Sponsor project manager.
We offer services of administration of a clinical trial in-house (TMF, correspondence with investigators and Sponsors, Investigator Folder and anything else as required). CTC project management can adapt according to the requirements of the customer and can proceed according to the Standard Operating Procedures of the customer. In order to ensure quality, data will be externally audited on a regular basis.

CTC organizes sessions of training in Good Clinical Practice for investigators and for personnel of the pharmaceutical, medical devices, biotechnology companies, audit training in clinical trials as well as internal audits for Contract Research Organizations. The sessions of training are held by certified trainers from European Union. GCP and Audit training schedule will be performed upon request.

Due to its national coverage CTC is able to provide a large database with potential investigators with different specialties as well as General Practitioners. Our database includes investigators from university hospitals, county hospitals and city hospitals from Romania. Selection of the investigators will be performed according to the requirements of the pharmaceutical, medical devices, biotechnology company, depending on their experience in clinical trials and on the number of patients that they may provide for a specific clinical trial. It is mandatory that the investigators should have GCP trainings. CTC is currently working with 40 county hospitals, 12 university hospitals, 53 city hospitals, approximately 1000 General Practitioner and 500 private practices. CTC has good connections with investigators from cardiology, pneumology, nephrology, neurology, diabetes and metabolic diseases, endocrinology, rheumatology, infectious diseases, obstetrics and gynecology, oncology and dermatology departments.

A new concept related to accuracy of data provided to Sponsor is mandatory in specific projects. Therefore, CTC offers “Flying nurse” services, a concept of completion of data at the site by a well trained study coordinator from CTC.

Professional monitoring is necessary to get reliable data in time. CTC is proud to offer one of the best-qualified monitoring teams in the country. CTC monitoring team understands both the practice of medicine and the practitioner, allowing them to earn the respect of investigators and coordinators alike. Monitoring activities include clinical site qualification, initiation visits, routine monitoring, drug accountability and close-out visits. Clinical Monitoring is performed according to ICH-GCP, EU Directives, FDA Regulations, CTC/Sponsor Standard Operating Procedures, National Legal requirements.

CTC is able to prepare the clinical trial documentation for submission to Romanian Regulatory Authorities (National Medicines and Medical Devices Agency) and National Ethics Committee for Clinical Study of the Medicine. CTC is also able to provide audit services of the documentation package of a clinical trial that is submitted to National Ethics Committee for Clinical Study of the Medicine and to National Medicines and Medical Devices Agency.

CTC auditor has experience in conduction of over 450 audits in over 160 clinical trials. We offer audit services for CROs, Pharmaceutical, Medical Devices and Biotechnology Companies, Laboratory and Site Auditing upon request.

In this respect, CTC have been developing collaborations and partnerships with many domestic and international companies.

In this respect, CTC have been developing collaborations and partnerships with many domestic and international companies.

With its experienced staff, CTC is able to provide certified translations of documentation related to the clinical trials from English to Romanian language and back translations.