Clinical Developments

clinical developmentsOur Coordination Unit has launched over twenty clinical trials and clinical validation programmes for technologies related to advanced therapies and regenerative medicine. Thanks to this consolidated experience, we have been able to optimize the planning and design processes associated with clinical developments in this area.

Our success is based not only on sound knowledge of the current regulations governing advanced therapies but also on continued dialogue with the regulatory agencies, guaranteeing both the strictest adherence to the applicable regulations as well as safeguarding patient safety.

We provide a maturing technological platform within the Andalusian Public Health System and we are in continuous contact with the Andalusian Health Biobank and the National Transplant Organization. This enables us to optimize both the development times as well as the costs of the clinical trials we promote, and, as a result, we are able not only to select the most appropriate hospitals and key opinion leaders but also to improve patient recruitment. + info at Clinical Trials completed or on-going

 

The Coordination Unit of the Andalusian Initiative for Advanced Therapies is committed to fostering synergies. In this regard, we have developed several alliances with institutions, research groups and companies.

The areas of cooperation are wide ranging. They cover every step in the development of advanced therapy medicinal products including basic research, pre-clinical regulations, regulatory and scientific advice, and clinical development as well as the processes involved in patent licensing and know-how.

All these collaborations have been developed in a framework of mutual and strategic benefit striving to enhance the generation of an effective business hub in the field of advanced therapies and regenerative medicine.