Clinical Trials

Design and planning of clinical trials

The professionals of the coordination unit of the Andalusian Network for the design and translation of Advanced Therapies have undergone specialised training in research methodology and have gained broad experience in the area of clinical research. This allows us to offer methodological support in preparation of clinical trial protocols as well as other essential documents related to a clinical trial (Investigator’s brochure, Patient Information sheet - Informed consent form, the investigational medicinal product dossier, etc.).

As we are part of the Andalusian Public Health System, we work very closely with its clinicians specialized in specific therapeutic areas of interest. This allows us to assess and select centres in accordance with the needs of the different clinical trials.

Clinical trial start-ups

Our expertise in clinical trial management enables us to offer services covering every aspect involved in the implementation of a clinical trial, i.e., from the preparation of the pertinent documentation to request authorisation and the management of contracts with participating centres up to the point at which clinical trial authorisation is obtained from the Spanish Agency of Medicines and Medicinal Devices.

Support throughout the development of clinical trials

The Coordination Unit of the ANd&tTA has highly qualified professionals to carry out the management of clinical trials according to the requirements set out in existing regulation, giving support to the research teams throughout the development of the clinical trial. This includes the monitoring of the trial, the processing of possible amendments or modifications of clinical protocols or the authorisation of possible compassionate uses of advanced therapy medicinal products.

Surveillance of the medicinal product safety

We have a sound knowledge of the regulatory requirements in matters of surveillance of the safety of the medicinal product in research as well as in pharmacovigilance. In addition, the collaboration agreement between the Andalusian Pharmacovigilance Centre and the Andalusian Network for the design and translation of Advanced Therapies should not be overlooked as it provides us with an added value.

Data processing of clinical trials

Finally, the data collection and processing of clinical trials are as important as the initial stages in their development. This stage must be well planned from the outset to ensure the maximum efficiency of the research. A detailed Data Processing Plan together with a thorough Plan of Queries and accurate monitoring throughout the whole clinical trial will guarantee the reliability of the clinical trial results. The Coordination Unit has the experience required to give support to researchers in these significant aspects.