Independent Research Center where observational studies as well as phase IIB, III, and IV clinical trials in Neuropsychiatry are carried out.
We have always approached our job with a careful assessment of the needs and demands of organizations that make great efforts in research and development of new products. For this reason we have designed a structure with optimum operations suited to the set of requirements requested by the sponsors and a previous feasibility study of such demands. It is worth mentioning that no more than 3 to 5 studies are carried out per year, in this way we have a low rate of protocol deviations and auditings made so far have found no significative findings. This allows us to continue qualifying for future protocols and be recognized in the field of clinical research in Argentina.
We have been in close contact and/or working actively with important organizations such as Bristol Myers Squibb, Roche, Otsuka, Takeda, Shire, Servier, Lunbeck, Abbott, Sunovion, Shering Plough, Eli Lily, AstraZeneca, Cephalon, Merck and with CRO such as Quintiles, PPD, I3 Research, ICON, INC Research and Covance.
PATIENTS
We carry out a detailed selection of patients to comply with all the requirements for the studies as well as Good Clinical Practices.
In our center we study pathologies in vulnerable patients so we try that these people get caretakers as well as supporting families. In this way, the patient compliance in the study is improved.
RESEARCHERS
The reasearch staff members have a wide experience, training, and certified continuing education in: GCP, IATA, as raters, CRF, IVRS/IWRS, etc.
They also have recruitment skills through the review of patients clinical records obtained from internal and external data bases.
COORDINATION
There is an adequate coordination of the clinical studies in the organizational, regulatory, economic and operational aspects (time and form). This is also seen not only in the compliance with norms of standard operating procedures of the site (SOPs) but also in the management of assistance and administrative personnel, the collection and delivery of samples and data and the adequate reception of monitorings and auditings.
ETHICS COMMITTEE
Our Center works in permanent communication with independent ethics committees and with the provincial ethics committee under respective regulations.
FACILITIES AND RESOURCES
- Necessary business permits and municipal sanitary authorizations up to date.
- Registered center and researchers authorized by RENIS and REPRIS.
- Updated registration in (National Direction of Personal Data Protection) Dirección Nacional de Protección de Datos Personales.
- Hired ambulante services (protected zone), for the transportation of biological samples, of equipment calibration and transportation of patients door-to-door.
- Study medication (in storage between 15 and 25 °C) and biological samples (in the freezer at
- 20°C and in the fridge between 2 and 8 °C) at a controlled temperature,under lock and key and under double lock and key if necessary (controlled medication).
- Updated agreements with clinics for possible hospitalizations.
- Standard Operation Procedures (SOPs) of the site.
- Equipment to perform ECG (Mortara) and electronic cognitive evaluations.
- Scales, thermometers, tensiometers and centrifuge (all of them with continuous calibration).
- Internal and external data base, paper-based medical records, photocopy machine, analog data transmission over a telephone line, computers with Internet access, fax.
- Breakfast/Snack service
