Clinical Trials Unit
The IOBA Clinical Trials Unit provides the infrastructure, latest high-tech equipment and highly specialized personnel for institutional and industrial partners, whilst offering regulatory expertise in compliance with Good Clinical Practice (GCP), European Directives and bioethical law. At all stages from the preparation phase up to the conclusion of the study, the CT Unit offers different types of support, which include:
- Advice and support in clinical trials
- Expert consultation on study design and methodology in clinical trials in ophthalmology and optometry
- Design of case report forms for data collection and additional documentation of clinical trials
- Relations with Contract Research Organizations (CROs) in conducting and designing clinical trials
- Technical assistance for regulatory procedures and relations between IOBA and reference Ethics Committees
- Recruitment of healthy volunteers and/or patients
- Technical and logistical support for protocol implementation
- Participation of a qualified medical team
- Data management and analysis
- Online Training in Study Coordinator fundamentals and Good Clinical Practice (R2) (Transcelerate Mutual Recognition)
IOBA has participated to date in more than 60 clinical trials with drugs, medical devices and advanced therapies in ophthalmology and optometry, in addition to numerous prospective observational studies.
The Clinical Trials Unit is responsible for relations between the PI (principal investigator), their research team and the patients of each project, as well as for external relations with the Health Authorities, Ethics Committees, clinical trials sponsors and Contract Research Organizations (CROs).
To facilitate implementation of such projects, IOBA has the infrastructures, necessary equipment and personnel to carry out all types of clinical trials in the area of ophthalmology and vision sciences, as required by GCP Standards.
IOBA has specific examination rooms and certified visual acuity rooms, as well as areas for archiving and monitoring.
Collaboration with «University Clinical Hospital”
In 2015, in order to promote joint clinical trials and clinical studies in Ophthalmology and Vision Sciences, a joint unit was created under a Specific Agreement signed between the University of Valladolid and the University Hospital Administration ( Sacyl.)
The Hospital staff of the Joint Unit is represented by Dr. María Isabel López as Principal Investigator, and Marian Quevedo as the Study Coordinator.
Controlled Environment Laboratory (CELab)
Controlled Environment Laboratory (CELab) is a unique facility that allows for the control of pressure, humidity, temperature, luminance and airflow and has the following potential benefits:
- More reliable diagnostic test values that reduce the number of subjects necessary to obtain statistically significant results.
- By running a large amount of evaluation tests and biomarkers, the efficacy of the potential therapeutic candidate is widely defined.
- The most valid end-points can be selected for further multicenter clinical trials, eliminated those that showed no signal.
- Ability to obtain a “yes/no” answer before running a large sample of patients for multicenter clinical trials with registration purposes.
- Increases speed and saves economical resources in drug development, registration, and commercialization programs.
Laboratorios y Unidades de Investigación Clínica
Clinical research at IOBA covers a wide range of activities, deriving directly from patient care or as a result of laboratory and translational research. The IOBA Clinical Research Facility will support any research that requires the input of patients, from lab tissue sampling to trials from phases I to IV.
EXPERIENCE IN PHASES II, III AND IV CLINICAL TRIALS IN:
Age-related macular degeneration
Retinal venous occlusion
Dry eye and ocular surface diseases
Contact lenses and other medical devices related to visual sciences
Telephone: +34 983184734
Clinical Trials Unit Medical Manager
Clinical Trials Unit Study Coordinator
Ana Rodríguez Andrés
Dr. Agustín Mayo Íscar
Dra. Maribel López Gálvez
Dra. Marina López Paniagua.
Esther Murgui Tejedor
Francisco Blázquez Araúzo
Laura Sanz Blanco
Marian Quevedo Gallego
Marta Blanco Vázquez
Certified Best Corrected Visual Acuity Lane
Previously certified by EMMES, KLINITRIAL, ETONWOOD and CLINICAL EDGE
5 Exploration rooms
1 Clinical Trials dedicated Exploration Room
4 Refraction rooms
Investigational products and ancillary supplies restricted and condition controlled storage area.
Study coordinator / Monitoring area.
Controlled Environtment Laboratory (CELab)
Heidelberg HRT-III Cornea (Rostock)
OCT – Optical Coherence Tomography
Zeiss Cirrus OCT 5000D
Topcon OCT 2000
Heidelberg Spectralis (through Joint Trials Unit HCU-IOBA)
Topcon TRC 50-DX
Topcon TRC 50-DX
Humphrey Field Analyzer 750i
GCP – GOOD CLINICAL PRACTICE (ONLINE TRAINING)
Good Clinical Practice (R2) – Transcelerate Mutual Recognition Compliant
Study Coordinator Fundamentals
QUALITY SYSTEM – AENOR ISO 9001 (2005-2021)
Electronic data capture
Experience in RAVE, Medidata, Quintiles, and Inform EDC among others.
OCT / Fundus Photographs / Angiographies
Certified Technicians for previous studies in DARC, Eyekor, Vienna RC, Bern RC, Duke RC and Wisconsin RC.
IATA certified personnel for human samples transport.
Refraction and Best Corrected Visual Acuity
Technicians with more than 15 years experience in Trial Refractions and BCVA Testing previously certified by EMMES, Klinitrial, Etonwood and Clinical Edge.