managers and sponsors specialized in biomedical research
Applied clinical research by means of Clinical Trials is one of the main research activity areas of the hospital and of the Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS, Health Research Institute of Santiago de Compostela). Our purpose is to systematize and speed up the conducting of Clinical Trials, and to achieve this goal we have established our own procedure for their management. IDIS offers support for the launching and the processing of all required documents to conduct all the non-commercial and commercial Clinical Trials promoted by the Pharmaceutical Industry in the Health Care Area of Santiago de Compostela and Barbanza, and the Health Care Area of Lugo, A Mariña and Monforte de Lemos.
We act as a connection between Clinical Trial Sponsors and Researchers, drafting contracts, managing different authorizations, ethical opinions, regulatory matters, and those documents which are essential for the carrying out of this kind of Trials.
Researcher Support Services
- Advice on regulation aspects, requirements and documentation for a clinical research trial.
- Starting the trial: applications to CEIC, AEMPS and corresponding Spanish regions. Support when preparing the required documentation.
- Other formalities and procedures with CEIC, AEMPS and the corresponding Spanish regions: responding to clarifications and corrections, submitting of amendments, expansion of centres, notification of start and end dates, sending of annual/final reports, payment of fees, etc.
- Quotation request and purchasing of insurance and hiring of CRO.
- Coordination and management of agreements with participating centres.
- Recording of clinical trials.
- Providing advice to the personnel from our Hospital Centre regarding the conducting and the managing of Clinical Trials promoted by the Pharmaceutical Industry.
- Production of certificates of Research Responsibility for our Chief Researchers.
- Monitoring of every clinical trial from start to finish.
- Processing of Addenda/Appendixes of all our Clinical Trials.
- Safekeeping and recording of the documents generated by researches from our Centre.
- Preparation of the financial cost report for every Clinical Trial, for signature processing with the Centre’s Management.
- Carrying out the invoicing process both for the Centre and for our Chief Researchers.
- Providing support to the Centre and Chief Researchers for signature management.
Services to businesses
FIDIS offers the required support to pharmaceutical, biotechnology and medical products industries and CROs which intend to carry out a new Clinical Trial at any of the centres belonging to our administration area.
We take care of any kind of issue related to agreements, research personnel, diagnostic tests, applicable legislation, pharmaceutical services, involved services, transfer of equipment, payment of travelling and food allowances to patients, device calibration and many other issues which may arise throughout the development of a Clinical Trial
- Identification of researchers and intermediation between sponsor and researcher for the carrying out of the trial.
- Support for obtaining local documentation (Chief Researcher commitment, adequacy of facilities, etc.).
- Carrying out the invoicing of sponsors.
- Providing support to Sponsor for signature management and Contract Management.
- Safekeeping and filing of the documents created by sponsors that so decide in our agreements.