Clinical Pharmacist Role

Outsourcing clinical research services is a standard practice in the pharmaceutical industry. It is attributed to the increasing complexities in the product development procedures, the desire to reach the markets faster, lack of internal expertise and financial restraints in setting up of the R & D team and infrastructure. As a service provider, a CRO (Contract Research Organization) offers a wide range of clinical research services to aid the sponsors in their R&D programs. It is well-known that the key to success in drug research is the appropriate selection of a CRO. The top factors that influence the decision of the pharmaceutical companies to finalize a CRO are: Processes for risk identification and resolution, team chemistry between CRO and sponsor, overall experience in the therapeutic area, recent experience in a similar indication and project execution plan1.

Pharmaceutical companies are ready to collaborate with CROs because of the wide range of services they are being offered. Right from Regulatory, Clinical Trial Management, Patient Recruitment, Site Monitoring, Medical Writing, Medical Monitoring, Pharmacovigilance, Data Management to Biostatistics. Resources and ability to conduct multi-centric therapeutic trials is often considered a major strength of CROs. Competition is fierce and ability to innovate continuously is required. To compete, many of the smaller CROs rightly emphasize customized service, faster response times or the ability to custom design a strategy that will shorten the process necessary to achieve regulatory approvals for a new drug2.

In order to develop and offer customized clinical research services, the CROs should be able to understand the needs of the sponsor, be attuned to their expected end objectives, create new and improved operational models to address key challenges and accommodate sponsors processes and systems. This can be achieved by offering them a single point of contact and maintaining a good rapport with the sponsor from day one. Proper utilization of available resources – defining roles, responsibilities and points of contact with the sponsor throughout the project lifecycle is essential. Effective and timely communication, prior identification of the pain points of the project and strategizing effective ways to handle them, are a few other critical steps towards successful completion of the project.

Customization of clinical research services is fundamental to customer satisfaction in the drug development cycle. Adopting an analytical and strategic approach helps CROs deliver solutions that effectively fulfill the sponsors research objectives and business goals.

Understanding the requirements of the sponsor and customizing the clinical research services are the need of
the hour and will go a long way in building a lasting relationship with the sponsor company.

REFERENCES:

1. Key Factors in CRO Selection- A recent survey uncovers key criteria that influence a sponsor’s decision when selecting a CRO. Publish date: Apr 1, 2008, Harold E. Glass, Daniel P. Beaudry
2. Small CROs customize service, Triangle Business Journal – Richard R. Rogoski