Contract Research Organizations

Nov 12, 2018 | 0 comments

Nov 12, 2018 | Miscellaneous | 0 comments

Contract Research Organizations

The utilization of contract research organizations by pharmaceutical industries in conducting clinical trials is gradually gaining popularity. The spiraling of this tendency to outsource clinical trial researchers has been contributed by a number of factors including the desire for quality. Carrying out clinical trials is extremely costly taking into account the fact that it consumes a lot of time and resources that most pharmaceuticals companies, especially upcoming ones, may not have. Contract research organizations on the other hand tend to have all the in house resources, expertise and necessary equipment that enables them to conduct all aspects of the trial without delay thus completing the research on time as desired by their clients hence the reason behind their utilization. Traditionally, contract research companies were incorporated in the research during validation stage to oversee quality as well as regulatory requirements but lately they are being utilized in the management of the entire clinical trial process due to their remarkable reputation in quality and timely deliverance as explicated by Glass & Beaudry (2008).

Outsourcing of research services also serves to lift the burden of conducting research of the pharmaceutical companies mainly if the research is to be carried out outside the country giving them the time and opportunity to focus on the development of the company. Outsourcing also helps in effective planning in regard to resource allocation since the contract organizations due to their experience in the field tend to provide an appropriate capital investment estimate required for the research thus minimizing the possibility of termination attributed to financial shortages. However, confidentiality is a major challenge with outsourcing. Considering the high level of competition in pharmaceutical industry, breach of confidentiality would cost the sponsors dearly as noted by Drucker & Hughes (2002).

References

Ali Abo Haded, H.M. (2014). Quality Management in Clinical Trials. Journal of Clinical Trials, 04(06). doi:10.4172/2167-0870.1000e119

Bairu, M., & Chin, R. (2012). Global. Clinical Trial Playbook: Management and Implementation when resources are limited. Burlington: Elsevier Science.

Barker, N.P. (2000). Total Quality Management of Clinical Trial Supplies. Clinical Research and Regulatory Affairs, 17(3), 231-245.doi:10.3109/10601330009005323

Drucker, R., & Hughes, G. (2002). Outsourcing in clinical drug development. Englewood, CO: Interpharm Press.

Glass, E.H., & Beaudry, D.P. (2008). Key factors in CRO selection. Applied Clinical Trial.

High Court rules against Heath Research Authority in clinical trial transparency case. (2015). The Pharmaceutical Journal. doi:10.1211/pj.2015.20069080

Joseph, J. (2008). Entering the contract research industry in India. Contemporary Clinical Trials, 29(3), 311-313. doi:10.1016/j.cct.2007.10.006

Kulakowski, E. C., &Chronister, L. u. (2006). Research administration and management. Sudbury, MA: Jones and Barlett Publishers.

Rondel, R. K., & Varley, S.A. (2000). Clinical data management. Chichester: Wiley.

Talluri, S., & Lee, J. Y. (2010). Optimal supply contract selection. International Journal of Production Research, 48(24), 7303-7320.doi:10.1080/0020754093436687