Presentation
The Drug Research Centre (CIM) began its activities in 1983, in collaboration with the Clinical Pharmacology service of Hospital de la Santa Creu i Sant Pau and the Department of Pharmacology and Therapeutics of the Autonomous University of Barcelona.
Service Portfolio
- Project planning and execution of phase I II III clinical trials.
- Study protocol planning and development.
- Expert advice on clinical development of drugs and food products.
- Preparation, submission and follow-up of applications to clinical research ethics committees and the Spanish Agency of Medicines and Medical Devices (AEMPS).
- Selection and recruitment of volunteers (volunteers and healthy subjects).
- Pharmacokinetic and pharmacodynamic clinical trials.
- Preparation of final study report and statistical analysis.
Facility Specifications
- Capacity of 24 beds
- Individual rooms for sleep studies
- Centrifugation and sample handling area
- Hospital de Sant Pau laboratory with direct connection
- Cold area and freezing area (20º and 80ºC)
- Rest area for volunteers (Sofa, TV, books, games...)
- Direct shipments to external laboratories of all types of samples
- Offices and monitoring area
Experimental Activities
Volunteer selection
Biochemistry and hematological blood samples
Experimental day procedures
Medication storage (HSP Pharmacy and CIM)
Medication administration
Blood draws for PK samples
Vital signs, ECG...
Blood sample management
Sample storage
Sample shipment
Medication received at Hospital Sant Pau Pharmacy
Count
Randomization (if applicable)
Shipment to CIM
Medication received at CIM Sant Pau
Count
Medication collection receipt
Storage under temperature and humidity
Randomization and group organization (if applicable)
Administration
Medication return
Database
- CRD design after final protocol version
- CRD review and design
- Data entry from source documents in paper format (CIM staff)
- Data management procedures to obtain the data
- Statistics of demographic data, vital signs, ECG, blood analysis...
Security Regulations
All studies conducted at the CIM of IR Sant Pau must have a protocol that includes the study objective, activities, inclusion criteria and planned timeline.
Ethical issues are also assessed, such as the benefit/risk ratio, financial compensation, protection and anonymity of participants. The informed consent must detail the tests, time required and financial compensation. Compliance with GCP, review of the protocol and consent by the Ethics Committee, as well as acceptance and authorization by the AEMPS is essential.
