PsicoMedica Research Group - General Overview
The institutional mission of PsicoMedica is to perform research activities based on good clinical practices (GCP/ICH), which fulfill local regulations, the Food and Drug Administration (FDA), and the European Agency for the Evaluation of Medicinal Products (EMEA) standards. Secondly, our Group provides clinical services for the general public through specialized programs that follow the standards of the international scientific community. Finally, we also provide continuing education courses, which focus on the professionals, the patients, and the public in general.
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PsicoMedica Research Group (Power Point Presentation) |
Since 1999, PsicoMedica’s professional group has systematically carried out clinical studies. As of April 2007, we have participated in 35 international, multi-center studies. Our principal sponsors have been Servier, Johnson, Astra-Zeneca, Wyeth, Merck (MSD), Pfizer, Novartis, Lilly, GSK, Forest, Solvay and Sanofi-Aventis. The following Clinical Research Organizations (CROs) have taken part in the studies mentioned above: Covance, Quintiles, PPD, PRA and Icon. The central laboratories we have worked with during those trials have been Covance, MRL, Biomedical Systems and Quest Diagnostics.
PsicoMedica has recruited patients suffering from Major Depressive Disorder (MDD), Bipolar Disorders in an acute mania, mixed and depressed phases, Panic Disorder (PD), Post Traumatic Stress Disorder (PTSD), GAD, Social Anxiety Disorder, Insomnia, Schizophrenia, Epilepsia, Alzheimer Disease, Parkinson Disease and Borderline Personality Disorder. In almost all protocols, our site enrolled the number of patients assigned. In most of the most recent protocols, our site was authorized to recruit a higher number of patients than the initial number assigned. PsicoMedica has developed recruitment strategies and organized independent working groups, which has allowed us to participate successfully in simultaneous studies for the same condition. For example, in a period of 15 months (2002-2003), we were able to randomize 99 patients with major depression for three different protocols.
PsicoMedica has regularly worked with an independent institutional review board, which is a branch of the US Western Institutional Review Board (WIRB), and most recently with the Comité Etico Científico, Servicio de Salud Metropolitano Oriente. Both have had a relatively brief response time (3-4 weeks) and their quality of work has been optimum.
With regards to the Psicomedica quality of work, it must be pointed out that our site has recently been successfully audited by the sponsors’ international quality control division in five separate studies.
Professional Staff:
PsicoMedica’s professional staff is composed of sixteen stable Psychiatrists, which includes Child and Adolescent Psychiatrists. Our staff also includes six Neurologists and Family Physicians. A well-rooted staff of study coordinators comprised of four university Registered Nurses and a Clinical Nurse Specialist, are on hand, dedicating themselves solely to their tasks. Twelve Psychologists, two Occupational Therapists and a Phonoaudiologist complete the clinical staff of PsicoMedica. The administrative staff has been trained in clinical research routines.
Recruitment Strategies:
PsicoMedica has developed general and specific recruitment strategies according to the characteristics of each study. Studies are successful due to several factors such as: working with a professional staff engaged in clinical activities at other institutions besides PsicoMedica; promoting activities through the mass media, focused on the identification of pathologies (not a direct protocol promotion); alliances with public and private health services; availability of leaflets with a checklist on psychiatric pathologies in waiting rooms; and telephone interviews with regular users of the clinical services, as well as educational lectures for the community.
PsicoMedica is located in the city in a traditional medical neighborhood. Its medical complex is specially adapted for clinical protocols, with easy access and a parking area for professionals and patients all within a 300 square meter area. It has twelve separate consultation offices, a comfortable waiting room, independent sectors for laboratory procedures that are fully equipped, along with a temperature and access controlled - drug and case report forms (CRF) storage facility room. There are special areas for the administrative staff and the study monitors. An integrated in-patient clinic with 16 beds is also available as part of our facilities.
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