Why are Contract Research Organizations Significant in the Pharma Industry?

Willie Martin, Director, Discovery Process, Alkermes

Willie Martin, Director, Discovery Process, Alkermes

Contract Research Organization (CRO) is nothing but a company that provides customized research services for the pharmaceutical, biotechnology, and medical device sectors.

Contract Research Organizations (CROs) have been around for quite some time now, are of various sizes, offer various services, and are present worldwide. The business strategies of CROs differ, and the sponsor must choose a CRO with a philosophy that suits their style. There are different types of CROs present, based on the types of services they offer. But commonly, CROs are segmented in discovery, preclinical, and laboratory services.

Clinical trial services offered

The primary clinical trial services offered by CROs are regulatory affairs, site selection and activation, site management, monitoring, logistics management, data management, pharmacovigilance, biostatistics, medical writing, and project management.

Importance of CRO in clinical trials

The importance of CRO in chemical trials is enormous because they assume a few specialized tasks that the clinical trial sponsor cannot handle. Clinical trials need numerous overwhelming activities beyond the scope of the sponsor’s know-how and resources so that the subcontracting this work becomes the best option. The CROs guarantees the technical proficiency needed in the clinical studies, making sure of the quality of the research and its results.

The advantages

By ensuring to fulfill the various demanding operational tasks involved in clinical trials, CROs liberate the sponsors to focus on their core business. Additionally, CROs can help with their knowledge and contracts that sponsors do not possess.

CROs specialization

Even though most CROs manage clinical studies in different diseases, some niche CROs are focused explicitly on a particular therapeutic area. For example, a CRO can be an expert in managing oncology trials only. This type of specialization is very valuable because such CRO will master the ins and outs of cancer trials, giving the sponsor key added value in terms of expertise.

Multiple CROs involved in a clinical trial

Leveraging more than one CRO in the same clinical trial is, in reality, a common practice. The utilization of numerous CROs is generally motivated by the need for service specialization and geographical coverage. A trial sponsor might have hired a CRO with strong capabilities in start-up, regulatory, and monitoring activities, but lack in data management and biostatistical knowledge. Then, another CRO will be subcontracted to handle these data-related tasks.