scholarly journals La implementación de un depósito para almacenaje de medicamentos de estudios clínicos

2014 ◽  
Author(s):  
◽  
Patricia Díaz Casapía ◽  
Juan Solano Arana ◽  
José Ventura Hilario ◽  
Daina Yenka Gutiérrez Vásquez
Keyword(s):  
Clinical Research ◽  
Research Organization ◽  
Clinical Research Organization ◽  
Los Grupos

Empresa que pertenece a la industria Farmacéutica, ubicada dentro de la categoría de Estudios clínicos. Denominada CRO (Clinical Research Organization – Organización de investigación por contrato). El rol que cumple la CRO dentro de la cadena de valor de esta categoría, es realizar los estudios clínicos por encargo de las Empresas Farmacéuticas que realizan desarrollo e investigación de medicamentos. Una vez realizadas las investigaciones pre-clínicas y clínicas por las empresas farmacéuticas, estas contratan a Depósitos para almacenaje de la droga y a las CRO, quienes ejecutarán el proyecto en cada país encargándose de reclutar los grupos de personas en las que se realizarán las pruebas, distribuir las drogas en los grupos seleccionados, para proceder a analizar y entregar los resultados a la empresa farmacéutica. Si los resultados reportados por la CRO son óptimos, la empresa farmacéutica procederá a registrar la patente y a la comercialización de los medicamentos. El éxito de los resultados de los Estudios clínicos depende de 3 factores principales: 1. Un almacenaje correcto de la droga en estudio, bajo condiciones óptimas de conservación. 2. Compromiso de los pacientes participantes, siguiendo estrictamente las indicaciones y las dosis planificadas para cada uno de ellos. 3. Monitoreo y análisis por parte de la CRO Actualmente los servicios que provee BIOCLINICAL RESEARCH a las Industrias Farmacéuticas son: Asesoría en el diseño de protocolos. Reclutamiento de investigadores. Monitoreo de estudios clínicos. Análisis de datos. de Fármaco-Vigilancia. Gerenciamiento de desarrollo del estudio clínico para el cual ha sido contratada la Compañía. Manejo de resultados de Estudios clínicos Considerando el impacto que representa el correcto almacenaje de la droga en análisis, para los resultados obtenidos; BIOCLINICAL RESEARH creará una nueva Unidad de Negocio, referida al almacenaje de los medicamentos para Estudio Clínicos; pretendiendo de esta forma, cerrar el círculo de suministro de la droga en estudio, desde que se importa hasta que se distribuye a los Centros de investigación para uso del paciente.

Ten Years of the Immune Tolerance Network: An Integrated Clinical Research Organization

2010 ◽  
Vol 2 (19) ◽  
pp. 19cm7-19cm7 ◽  
Author(s):  
J. A. Bluestone ◽  
A. M. Krensky ◽  
L. A. Turka ◽  
D. Rotrosen ◽  
J. B. Matthews
Keyword(s):  
Clinical Research ◽  
Immune Tolerance ◽  
Research Organization ◽  
Clinical Research Organization

General News

2005 ◽  
Vol 09 (10) ◽  
pp. 426-430
Keyword(s):  
Clinical Research ◽  
Research Organization ◽  
Chinese Government ◽  
Clinical Research Organization ◽  
Set Up ◽  
Hiv Aids

A New Cancer Syndicate. Bridgtech and Amcare Set Up A Clinical Research Organization in China. Merck and the Chinese Government Collaborate to Fight HIV/AIDS in China. New Multi-Million Dollar Vaccine in Melbourne.

scholarly journals Role of Regulatory Authorities on the Working of Contract Research Organization and Pharmaceutical Company’s Clinical Trials in India

2021 ◽  
Vol 16 (3) ◽  
pp. 87-91
Author(s):  
Poonam Chauhan ◽  
Monica Mendonca
Keyword(s):  
Clinical Trials ◽  
Drug Discovery ◽  
Clinical Research ◽  
Vital Role ◽  
Research Organization ◽  
Pharmaceutical Companies ◽  
Contract Research Organization ◽  
Contract Research ◽  
Target Disease ◽  
The Masses

The evolution of the drug development process and testing its efficacy is a primary responsibility of pharmaceutical companies. The time cost investment involved in identifying a compound suitable to its target disease and making it available to the masses eventually led to the rise of the Contract Research Organization (CRO) in the domain of clinical research.  Pharmaceutical companies outsource the research and clinical trials to CRO’s. A CRO has a vital role from drug discovery to the launch and marketing of drugs. India is emerging as attractive location for global clinical trial. It has cost advantage compared to other countries and a well-developed associated services like data management, medical writing and pharmacovigilance.  The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority in India that aims to bring safe drugs and standardize clinical research. Pharmaceutical Companies benefit by strategically working with CRO to gain speed and efficiency in drug discovery, generation and retention of clinical data integrity. The risk associated with CRO relates to delays and inferior quality of work, thereby making CRO a critical decision for Pharmaceutical Company.

scholarly journals Postgraduate pharmacology curriculum in current scenario and future prospects: an educational forum

2021 ◽  
Vol 10 (6) ◽  
pp. 770
Author(s):  
Virendra Kushwaha ◽  
Pooja Agrawal ◽  
Mangesh K. Tripathi ◽  
Vipul Shukla
Keyword(s):  
Clinical Research ◽  
Clinical Skills ◽  
Regulatory Body ◽  
Medical Council ◽  
Graduate Curriculum ◽  
Clinical Research Organization ◽  
Experimental Pharmacology ◽  
Current Scenario ◽  
Research Organisations ◽  
Clinical Departments

In India Doctorate of Medicine (MD) pharmacology is primarily knowledge oriented based on teaching, seminars, lectures and research related activities including animals and paper-based experiments and day to day management of undergraduate classes. MD pharmacology student should be competent of both clinical and experimental pharmacology. So, the postgraduate pharmacology curriculum should be competent to meet all the job requirements. Therefore, medical council of India (MCI) has introduced new post graduate curriculum which is based on knowledge, practical, clinical skills, thesis skills, and attitudes including communication and training in research. In India demand for skilled clinical research professionals is increasing day by day for growing pharma industries and good academician. So, there is an urgent need for the experienced and skilled pharmacologist to fulfil the requirements. MD pharmacology students should get posting in different clinical departments and observatory posting in industry, clinical research organization (CRO), regulatory body and research organisations. The course of MD Pharmacology should be like that fulfil all the skills that a pharmacologist must have.

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