Friday, December 17, 2010

What is Clinical Research Outsourcing?

What is Clinical Research Outsourcing?
Clinical Research Outsourcing can be described as the moving away from traditional, expensive and time-consuming in-house Research and Development to creating strategic partnership with external vendors who partner to deliver credible data at within timelines, complying with international regulatory standards and most importantly within the R&D budgets of the product. These clinical partners are popularly known as Contract Research Organizations (CROs).

The rise in Clinical Research Outsourcing It has been observed globally that there is a steady rise in the trend to outsource Clinical Research activities by Drug Development companies. A number of factors have contributed to this growing trend to partner with CROs.

The current scenario sees drug
developers face capacity constraints due to the increase in volumes in global clinical trials. Worldwide development may have taken a boost but many major pharmaceutical and biotechnology companies have not consciously increased their in-house personnel for internal clinical research.
A dramatic increase in the birth of small and medium sized Pharma and biotech companies who conduct atleast one clinical trial per 6 to 12 months have given way to outsourcing a much larger part of their total research budgets to experts who bring in the required overall clinical research expertise that falls outside their area of capabilities.

Many Sponsor companies are now of the opinion that CROs can definitely provide an advantage with respect to cost, timelines and varied therapeutic expertise. Kunal Bhatt, Global-BDM resonates the current trend that there is a rise in outsourcing
clinical trials to local CROs who have the local regulatory and operations expertise to conduct clinical trials and reduce the turnaround time for the completion of the study which is one of the main concerns of any Sponsor outsourcing the trial.

India Inc. and Outsourcing India since a while now has been considered as the Mecca of clinical outsourcing in South East Asia. ClinACE lists down the probable reasons for this: Huge population A good treatment nave population size with an advantage of varied therapeutic conditions. Affordable R&D costs and state-of-the-art amenities in large private and certain government hospitals attract global
pharmaceutical and biotech companies to conduct trials in India ensuring faster recruitment rates which ascertains reduced timelines. Data acceptability by foreign regulators which used to be of grave concern now seems to be a thing of the past. Indian CROs have repeatedly generated good quality, internationally accepted data by participating in various global multicentre studies. Companies are more confident about the safety of their molecule and primary data while outsourcing clinical trials to India. An overall Cost effectiveness and strict and complete adherence to timelines set has given way to a positive new outlook when contemplating on outsourcing to India.
In the current drug development environment, it is of prime essence that sponsors want to reduce the time taken to get a molecule from its nascent stage to commercialization the shift from the traditional in-house Research and Development to strategic, competency-based partnerships promises to help sponsors meet these challenges.

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