San Antonio Technologies offers its clients the necessary services to efficiently carry out all activities related to the development of clinical research studies in compliance with current legislation on biomedical research and clinical trials with drugs and medical devices as well as clinical trials with food and food supplements.

Therefore, the first step is to understand the company's needs in order to propose quality study designs whose execution is feasible and meets the expected deadlines. To this end, San Antonio Technologies has a team of professionals specialized in the methodology of clinical studies, both experimental and observational.

The SAT's portfolio of services in the field of both unicenter and multicenter clinical studies includes the following activities

• Feasibility study of centres, investigators and clinical trial protocols
• Clinical study design and methodological advice
• Development of strategies for the recruitment of study participants
• Preparation of study documents
  • Protocol
  • Data Collection Notebook
  • Patient Information and Informed Consent Form
• Regulatory and Legal
  • Presentation and Application of authorizations to the AEMPS, CEI, CEIm and CCAA
  • Advice on ethical and regulatory aspects for the development of clinical research projects
  • Communications with health authorities: Monitoring reports, safety reports, final reports.
  • Preparation and maintenance of essential study documentation
  • Management of Contracts with Promoters, Researchers, Foundations, Hospitals and suppliers
• Product in research, materials and samples
  • Packaging of products under investigation
  • Product management in research
  • Management of the materials necessary for the development of the study
  • Management of Biological Samples
• Monitoring, coordination and compliance with the Good Clinical Practice Standard
  • Elaboration of the Monitoring Plan
  • Initiation, monitoring and closure of studies
  • Technical support to ensure compliance with all aspects of the GCP implementation.
  • Coordination of Multi-centre Studies
• Audits
  • Preparation of audits and inspections by health authorities and promoter
• Clinical Data Management
  • Database Design and Management
  • Statistical Analysis
• Final results report
• Publication of results
• Clinical trial records and database maintenance: ClinicalTrials.gov, others.

San Antonio Technologies has a team of biostatisticians with extensive experience in the development of the Statistical Plan and in the analysis of data generated in clinical trials and other research studies.

As a result of collaboration with specialized internal and external groups, San Antonio Technologies has extensive experience in skin, oral, intestinal and vaginal microbiota studies. Human intestinal microbiota is emerging as a primary focal point for various disciplines, primarily because of its contribution to health and disease risk throughout the life span.

San Antonio Technologies has pilot plant facilities for the design and manufacture of food grade products for use as food ingredients and food supplements. We also have external facilities for food grade packaging where we can produce sachets, capsules and tablets.

In addition, SAT has a group of experts in the design and formulation of food and beverage supplements.
 

San Antonio Technologies has experts in international food regulation to provide expert reports and assist clients with new product applications and dossiers in any global legislative environment.

In addition, SAT supports its clients in complying with food and dietary supplement labelling, advertising and promotion standards in any country.