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QUALITY SERVICES IN CLINICAL RESEARCH.

Do you want to carry out a clinical research project?  Contact us.

The main objective of the FTH is to provide all the necessary services in a clinical research project, including scientific and technical support in project design, protocol drafting, commissioning, monitoring, Case Report Form (CRF) design, management of clinical data, preparation of final results reports, statistical analysis, and translation of scientific content.

All our activities comply with the ethical principles that have their origin in the Declaration of Helsinki and with the Standards of Good Clinical Practice (GCP) and current Legislation.

Since 2017 we have the ISO 9001: 2015 Certification for Quality Management Systems, which includes the Coordination, Management and Monitoring of Clinical Trials.

Our purpose is continuous improvement and simplification of clinical research processes, in order to support our clients to achieve their goals and improve people's health. As a valuable asset, we have the experience and invaluable collaboration of our Project Management Team, Consultants, Commissioning, Monitoring and Quality Management.

We wish to collaborate with you in the near future and offer you our full support for the correct conduct of your research studies.


Project Management

We organize and develop the different stages of the clinical study, managing it in a hybrid, agile and innovative way to carry it out on time and within budget: guaranteeing the success of your project and complying with current regulations.

Audits and Quality Assurance

We ensure compliance with the Standards of Good Clinical Practice (GCP) and we guarantee that the study procedures comply with the requirements legally established by national authorities and ICH (12). We have an accredited Quality Management System that complies with the ISO 9001: 2015 standard.

Start Up

We have an updated data record of contacts, established legal requirements, specific models of the centers, contracts that allow us to speed up all the appropriate administrative procedures.

Monitoring the Clinical Trial 

Our monitors have extensive experience in clinical research, in different therapeutic areas. Which guarantees a high quality in the tasks they perform. Currently we have a team of highly qualified CRAs who receive continuous training aimed at improving the development of their functions and results.

CRF & Clinical Data Management

FTH has extensive experience in CRF design and clinical data management. These management activities, together with monitoring, guarantee the quality of the data, certifying that they are truthful, safe and rigorous.

Medical-Scientific writing and Biostatistics

Medical-scientific oversight of research activities which include clinical and regulatory writing, as well as scientific communications, medical writing consultancy, and education / training material.

Pharmacovigilance in the Clinical Trial

At the FTH we are committed to the need of our clients in legislative compliance and in the proper management of activities related to drug safety and drug development.

Over 25 years of experience in R&D Drug Discovery