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Clinical research

28 years of experience in the design and management of clinical trials. As a CRO (Contract Research Organization), we develop each project from start-up and authorization management to the preparation and publication of the final results report.

We have the ISO 9001:2015 accreditation, which ensures compliance with Good Clinical Practices (GCP) and the quality of our work.

 

Committed to high-quality research and the safety and well-being of patients

Our objective is to ensure the success of our clients’ projects, on time and in the proper manner, streamlining processes and maintaining close contact and continuous monitoring with the competent authorities, the centres and their foundations, researchers, and sponsors. Our commitment to rigour is unwavering, as we recognize the importance of our work in improving people’s health and quality of life. 

We provide all the services required for the proper development of a clinical research project, ensuring the traceability and quality of the data. We strive for continuous improvement and simplification of processes to help our clients achieve their goals and to contribute to improving people’s health. 

Our services cover the entire spectrum of clinical research projects in different therapeutic areas, from consulting and scientific advice on project design, protocol drafting and implementation, through monitoring and design of the data collection form (CRF), data management, analysis, and preparation of the statistical report (SAP), to the drafting of the Clinical Study Report (CSR) and its publication.

We carry out our services in compliance with the ICH Guidelines, the Spanish regulation (RD 1090/2015, which regulates clinical trials with medicines and medical devices), the European regulations (Regulation (EU) no. 536/2014, which guarantees the protection of the rights, safety, and well-being of participants in clinical trials, as well as the reliability and robustness of the data obtained in clinical trials, and Regulation (EU) 2016/679 which guarantees the protection of natural persons in connection with the processing of personal data and the free circulation of those data).

In addition, since 2017 we have held ISO 9001:2015 Certification for Quality Management Systems, which covers the Co-ordination, Management, and Monitoring of Clinical Trials.



Do you want to carry out a clinical research project?

Do you need support with any procedure?

 Learn about our services

Clinical Trial Services

START-UP ACTIVITIES

  • Scientific advice and consulting

  • Design and preparation of the protocol

  • Preparation of the Participant Information Sheet-Informed consent / Local review and adaptation

  • Selection of centres

  • Design, content, and validation of the template of the electronic Case Report Form (eCRF)

  • Preparation of the Data Management Plan


AUTHORIZATION MANAGEMENT (CTIS)

  • Compilation of local documentation for authorizations
  • Management of authorizations / National and European regulations (CTIS)
  • Negotiation of the contract and financial aspects with the centres


PROJECT CO-ORDINATION AND MANAGEMENT

  • Management, planning, execution, and monitoring of the project
    • Own or sponsor’s SOPs
  • CTIS maintenance, notifications and monitoring
    • Updating and maintenance of the TMF (sending to the sponsor)
  • Management of the despatch of samples
    • Management of the despatch of medication
    • Spanish Clinical Trials Registry (REEC: Registro Español de Ensayos Clínicos)
    • REEC

MONITORING

  • Preparation of the Monitoring Plan
  • Monitoring visits and reports
    (start-up, follow-up, closure)
  • ISF updating / Query management
  • Remote monitoring visits and reports
  • Training of research team
  • Gestión de centros
  • Management of centres



PHARMACOVIGILANCE OF THE TRIAL

  • Management and monitoring of SAEs and AESIs
    (notification to the sponsor)
  • Risk Management Plan
  • DSUR



ANALYSIS AND MANAGEMENT OF DATA

  • Cleaning, quality control, and validation of data
  • Closure of database and exporting of data
  • Statistical Analysis Plan, statistical analysis, and final statistical report (SAP)
  • Clinical Study Report (CSR) and its publication

Other services

  • Biostatistics and epidemiology
  • Quality assurance (QA)
  • Outsourcing de personal

Some figures:

150 +

Active ingredients studied

350 +

Clinical trials carried out

10000 +

Subjects recruited

50 +

Collaborating public and private centres in Spain and Portugal

15 +

Annual projects

10 +

Therapeutic areas in various diseases

10 +

Loyal companies in the pharmaceutical industry (national and international)


Some facts that define us:

  • CRO local y global
  • Ensayos clínicos fase I de bioequivalencia y farmacocinética en voluntarios sanos
  • Ensayos clínicos fase II y fase III
  • Estudios observacionales postautorización con medicamentos (fase IV)
  • Ensayos clínicos con productos sanitarios con y sin marcado CE
  • Estudios nutricionales
  • Estudios con probióticos
  • Diferentes áreas terapéuticas:
    oncología (cáncer de mama), onco-hematología (leucemia), dermatología (dermatitis atópica, rosácea), oftalmología (ojo seco), neurología (enfermedad de Alzheimer, enfermedad de Parkinson, lesionados medulares, ictus cerebral subagudo y crónico), ginecología (endometriosis, vaginosis), nefrología (diálisis peritoneal), etc.
  • Calidad, comunicación con el promotor, seguimiento estrecho con los centros y eficacia en la resolución de imprevistos

Learn about some of the projects we are involved in

MammoWave – nueva técnica diagnóstica

Investigación Clínica - Proyecto Mammo Wave

Regenera – nuevo implante mamario

Investigación Clínica - Prótesis mamaria
Location:

Fundación Teófilo Hernando (FTH)
Edificio Las Rozas 23, planta S, Oficina 1
Ctra. de La Coruña, km 23,200
28290 Las Rozas de Madrid, Madrid, Spain


Clinic and teaching accredited by:
Contact:

info@ifth.es
(+34) 911 923 700


Certified Information Security Management System:
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