Clinical Trials Center Prague
Clinical Trials Centre (CKH)
Affidea Praha s.r.o. Since 2000, it has been systematically involved in the implementation of clinical trials II and III. Phases, mainly in the field of pharmacotherapy of osteoporosis, diseases of the musculoskeletal system, cardiology. In terms of the number of randomized patients in rheumatological and especially osteological clinical trials, it ranks among the centers with the highest recruitment within the given clinical trials in the Czech Republic. And this results in audits of regulatory bodies (SÚKL, FDA).
In addition to clinical trials, in which the staff of Affidea Praha are their main investigators, CKH offers the performance of specialized imaging examinations, especially MRI, CT or DXA for clinical trials (oncology, urology, rheumatology, gynecology), which take place at other workplaces.
CKH Affidea Prague cooperates with the pharmacy of the EUC clinic, located on the same floor of the polyclinic building, as part of meeting the requirements of the State Institute for Drug Control regarding the distribution of drugs for clinical trials.
Number and type of clinical trials
Dozens of clinical trials have been and are successfully carried out in our centre – the vast majority in the field of rheumatology and osteology (our centre was part of the so-called registration studies for a number of drugs), for other clinical trials performed in other centres we have provided and continue to provide the necessary examinations (especially MRI, CT and DXA).
Personnel
The team of examiners has several fully qualified and trained study nurses/coordinators with many years of experience. The team members have completed a number of trainings related to Good Clinical Practice (GCP), data processing and entry into electronic databases, etc. Language skills and the ability to communicate with employees of cooperating organizations abroad as well as participation in teleconferences and telephone trainings are a matter of course.
Cooperating organisations and contracting authorities
In the field of clinical trials, CKH cooperates with a number of large and smaller CROs as well as original pharmaceutical companies and their departments dealing with clinical trials.
Technical equipment and infrastructure
CKH has specially designated and equipped premises for its activities and uses the state-of-the-art technical infrastructure of its own medical facility (interconnected computer network, the possibility of sending image material via the PACS system, a separate fax line exclusively for this centre, receiving and storing faxes in digital form). Easy cooperation and accessibility for various courier companies is made possible by reception opening hours (7:00-19:00).
Quality Control
The quality of the data obtained, ensured by standardized procedures, is priority to us. This quality has been verified and confirmed in a number of audits and inspections by both clinical trial sponsors and regulatory authorities.
In the field of imaging methods, we have been cooperating for many years with the world's largest organizations providing multicenter evaluations and quality control of these methodologies.
Contractual arrangement and contact
CKH accepts and flexibly comments on standard models of sponsors' contracts on cooperation between the sponsor and the medical facility. Correspondence and commenting on contracts regarding this cooperation and questions regarding the feasibility phases of clinical trials are handled by the head of the CKH, MUDr. Petr Kasalický, CSc. (kasalickyp@affidea-praha.cz, tel. 267090828).