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.
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.