PROCEDURES

The site conducts clinical trials in accordance with ICH-GCP standards, Pharmaceutical Law and the regulations of the EMA and FDA.

In order to efficiently start the study:
• negotiation of contract adapted to Polish legislation takes 5 working days.
• recruitment strategy is developed iIn each project.

Personnel conducting the clinical trial is trained on GCP, Polish law and, if required, IATA.

Center has internal standard operating procedures (SOP) for all stages of the clinical trial.

The procedures are available on request.

The site cooperates with qualified and experienced in clinical trials doctors and supporting staff.

Each study has assigned study coordinator who is responsible for the project administration and the timeliness of data entry.