Centre for Clinical Trials

Since 2000 Affidea Praha 4-Chodov has been doing clinical trials of II. and III. phase in pharmacotherapy for osteoporosis, musculoskeletal diseases, cardiology and angiology. According to the number of randomized patients it belongs to the centers with the highest number of patients within given clinical trials not only in the Czech Republic, but also globally. 

Apart from clinical trials where Affidea Praha 4 Chodov are the main researchers, the center also provides specialised examinations for clinical trials (in oncology, urology, diabetology) which take place at other facilities. 

The center is also developing cooperation with the pharmacy (SZZ-JMII) located on the same floor of the clinic building. 

Number and Type of the Clinical Trials 

Our center has successfully held and run more than 17 clinical trials – mostly in osteoporosis and rheumatology.  For 14 trials from other facilities we have provided required examinations (especially CT and DXA). Extension of specialisations of Affidea Praha 4 – Chodov enables development of these activities and focusing on other areas of expertise. 

Staff 

The team of examiners has also two fully qualified and trained nurses/coordinators. The members of the team have attended a series of trainings regarding good clinical practice (GCP, processing and data entry into electronic databases, etc. They can also speak foreign languages and are able to communicate with the staff of cooperating organisations abroad as well as participate in teleconferences and phone trainings. 

Cooperating Organisations and Authorities 

In clinical trials the centre cooperates with a number of original companies (Amgen, AstraZeneca, GSK, Novartis, Pierre-Fabre, Pfizer) and bigger and smaller CROs (ICON, MDS, Parexel, Quintilles, Eastcom).

Technical Equipment and Infrastructure 

The centre has for its activities specially designed and equipped premises available and uses cutting-edge technical infrastructure of their own medical facility (interconnected computer network, sending imaging via PACS system, separate fax line exclusively for this centre, digitalised reception and storage of faxes, digital PBX with call records). Easy cooperation and availability for various delivery companies is enabled by the working hours of the reception (7am-8pm). 

Processing biological samples before sending them to the central laboratories relevant to the clinical trial is carried out in our well-equipped biochemical laboratory which, among other things, also has refrigerated centrifuge. 

Quality Control 

The quality of the collected date, secured by standardized processes is of utmost importance for us. Affidea Praha 4 – Chodov is certified by ISO 9001:2000. Our centre has successfully gone through a series of audits from the authorities (Pfizer, ICON, Sanofi-Aventis).

In the field of imaging for many years we have been cooperating with the world’s largest organisations providing multicentric assessment and quality control of these methods (especially SYNARC, BioImaging). 

Contractual Security and Contact

The center accepts and flexibly comments standard contractual models of the sponsors about the cooperation between the sponsor and the medical facility. Correspondence and comments regarding the cooperation and questions regarding various phases of the trial are the responsibility of the Head of the Center MUDr. Petr Kasalický, CSc. (kasalickyp@affidea-praha.cz, tel. 267090828).