INFORMATION FOR SPONSORS
The Clinical Trials Unit is formed by personnel qualified for the development of the different functions involved in the clinical development of medicines, with the aim to provide a quality service to clients.
The different profiles and continuous training of the personnel in their work environments allows to carry out tasks ranging from those related to the implementation of clinical trials in the hospital, clinical trial design, development of protocols, data analysis and preparation of final clinical trial reports.
The Unit has spacious facilities (193 m2), distributed in: 135 m2 for the clinical development of the trials, 25 m2 for the laboratory for processing and storage of samples, 5 m2 for the reception, 13 m2 of office and 15 m2 of waiting room.
The hospitalization area has: two rooms with 6 recliner chair beds each, for the admission of patients and / or healthy volunteers, 2 medical consultations with a recliner chair bed each, two bathrooms with alarm system (one of them equipped with shower), an office and a nursing control.
In addition, there are available the necessary material for an adequate monitoring of the participants and a video surveillance system.
For the leisure of the volunteers or patients, Wi-Fi, televisions, DVDs and games are available.
The sample processing laboratory has modern equipment for the correct handling of clinical trial samples, complying with Good Laboratory Practice (GLP) standards.
We can develop the following activities:
- Preparation of protocols.
- Submission of clinical trials to CEIm and AEMPS.
- Clinical development of all phases of clinical trials.
- Development of studies with food and health products.
- Statistical analysis of results (Pharmacokinetics, Pharmacodynamics and Adverse Events).
- Preparation of the final report.
- Elaboration of expert reports.
- Scientific advice.
- Publication of results.
The Unit has a great commitment to quality. To this end, it has Standard Operating Procedures (SOPs) to guarantee that clinical trials are always carried out respecting the current regulations and Good Clinical Practice (GCP) standards.
Since 2012 Unit is accredited by the Community of Madrid in GCP verifying compliance with the regulations in force in the European Union and the Spanish State.
Later, in 2016, the unit was certified in the ISO 9001: 2015 quality system.
All the equipment in the unit, both clinical equipment and laboratory equipment, has calibration certificates.
In addition, in the Unit we support a continuous training of our professionals in GCP as well as in the handling of emergency situations and in international regulations for the handling of biological samples.
To access the unit’s quality policy click here
Director: Dra. Dolores Ochoa Mazarro
Scientific Director: Dr. Francisco Abad Santos
Deputy Director: Mr. Manuel Román Martínez
Coordinator: Mr. Sergio Luquero Bueno
Clinical Trials Unit
University Hospital La Princesa
C / Diego de León 62 – 7th Floor
Phone: + 34 91 520 22 47
Monday to Thursday: 8.00 – 17.00
Friday: 8.00 – 15.00