Importance of Partnering with CROs in the Drug Development Process
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Pharma Tech Outlook: Pharma Tech Magazine

Importance of Partnering with CROs in the Drug Development Process

Samuel Jackson,Quality Manager,Zoetis

Samuel Jackson,Quality Manager,Zoetis

The Covid-19 pandemic has improved public awareness of the pharmaceutical business and the clinical development process. The newest industrial advancements and clinical breakthroughs during the epidemic would not have been achievable without CROs.

Outsourcing non-core services and resources is common in today's world as businesses look to cut costs and streamline their operations. Pharmaceutical companies outsource clinical research to contract research organizations (CROs) for various reasons, including the CRO's therapeutic expertise, cost savings, and geographic reach. However, they do so to expedite the delivery of new drugs and treatments to patients.

While CROs are well-known as outsourcing partners in the life sciences sector, other industries are also familiar with the concept. Over the years, technology companies, for example, have been vocal proponents of outsourcing. Skype used outsourcing services to develop the back-end of its app, and Google has increased its reliance on outsourcing firms such as Cognizant.

Clinical research CROs range from global players covering all aspects of the clinical trial process, every therapeutic area, and every geography to smaller niche players specializing in a particular disease area. With over 1,000 CROs worldwide, the CRO market will grow at a 13 percent compound annual growth rate through 2022, reaching $71.7 billion by 2024. While healthcare organizations are well aware of the benefits of outsourcing, there are a few key principles to follow to maximize using a CRO.

CROs should be viewed as more than just useful resources; they should be viewed as collaborative partners throughout the drug development process. To ensure a smooth partnership, sponsors should keep the following in mind:

Choosing the right CRO is critical, as the expertise and reach of each CRO vary. A rigorous vetting process provides an opportunity to download information about the CRO and how they can assist a sponsor in meeting their clinical objectives. CROs come in various shapes and sizes, with varying geographic reach and technical and therapeutic capabilities. Geographic reach or therapeutic focus can be critical for patient recruitment, particularly if a trial requires the participation of a specific population group. Developing an effective governance structure between the parties is critical to success. It must be backed up by proper role assignment and escalation procedures. Given the complexity of clinical trials, this ensures that all parties can manage the project's scope effectively and remain aligned on processes, deliverables, and expectations. A CRO and sponsor should agree on measuring success to ensure that both parties get the most out of the partnership. Using performance indicators to ensure efficiency is a good idea. While sponsors may be tempted to impose specific standards or structures on CROs, adopting the standards of another organization is frequently less effective than a CRO adhering to their own. This entails placing trust in the CRO—they are the experts and are well-versed in their field. Communication is critical in any partnership. All parties involved must communicate regularly and transparently. This alone can help avoid the majority of problems.

Over the last few decades, CROs have played a significant role in the pharmaceutical industry, evolving into something more than a simple outsourcing resource. They are thought leaders in the field, active participants in clinical research, and significant contributors to the industry's success. Sponsors should embrace these collaborations, and by establishing clear performance indicators, standards, and a transparent governance structure, they can ensure a fruitful relationship.

CROs are an invaluable resource in an industry where time is money, and they contribute significantly to the success of numerous studies and the development of much-needed drugs and treatments.

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