Putting Contract Research Organisations on the Radar: An Exploratory Study on Outsourcing of Clinical Trials by Pharmaceutical Companies To Contract Research Organisations in Non-Traditional Trial Regions

2011 ◽  
Author(s):  
SOMO Submitter ◽  
Mariette Van Huijstee ◽  
Irene Schipper
Keyword(s):  
Clinical Trials ◽  
Exploratory Study ◽  
Pharmaceutical Companies ◽  
Contract Research ◽  
Research Organisations ◽  
Contract Research Organisations

scholarly journals Putting contract research organisations on the radar

2012 ◽  
Vol 9 (2) ◽  
pp. 32-34
Author(s):  
Mariëtte van Huijstee ◽  
Nuria Homedes
Keyword(s):  
Clinical Trials ◽  
Third Parties ◽  
Pharmaceutical Companies ◽  
Middle Income ◽  
Contract Research ◽  
Middle Income Countries ◽  
Research Organisations ◽  
Contract Research Organisations ◽  
Low And Middle Income

There is a trend for pharmaceutical companies to contract third parties to conduct the clinical trials that are needed to test their drugs. This trend is referred to as outsourcing, and the companies that carry out the work are called contract research organisations. In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low-and middle-income countries. This trend is called offshoring. The combination of outsourcing and offshoring poses serious risks for the ethical treatment of participants in clinical trials.

scholarly journals Big-pharmaceuticalisation: Clinical trials and Contract Research Organisations in India

2015 ◽  
Vol 131 ◽  
pp. 239-246 ◽  
Author(s):  
Salla Sariola ◽  
Deapica Ravindran ◽  
Anand Kumar ◽  
Roger Jeffery
Keyword(s):  
Clinical Trials ◽  
Contract Research ◽  
Research Organisations ◽  
Contract Research Organisations

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.

Practical issues in conducting multinational, multicenter trials managed by Contract Research Organisations

1994 ◽  
Vol 9 (3) ◽  
pp. 151-153
Author(s):  
M Placchi
Keyword(s):  
Drug Therapy ◽  
Therapeutic Agent ◽  
Clinical Development ◽  
Phase Iii ◽  
Contract Research ◽  
Multicenter Trials ◽  
Practice Organization ◽  
Research Organisations ◽  
Joint Evaluation ◽  
Contract Research Organisations

Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.

scholarly journals COVID-19 challenges in clinical trials

2021 ◽  
Vol 10 (6) ◽  
pp. 769
Author(s):  
Murugan Panchatcharam ◽  
Sravanthi Lakshmi Mukku
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subjects ◽  
Well Being ◽  
The Past ◽  
The Face ◽  
Current Scenario ◽  
One Year ◽  
Research Organisations ◽  
Contract Research Organisations

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

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