The Vital Role of CROs in the Drug Development Journey

Pharmaceutical companies should adopt CRO partnerships as they play a crucial role in the success of many studies and in bringing much-needed drugs and treatments to patients.

FREMONT, CA:The pandemic has put the pharmaceutical industry in the spotlight, sparking public interest in the clinical development process. CROs played a significant role in the latest advances in the industry and clinical successes during the pandemic. Regarding niche areas and wider technologies, CROs are a valuable resource for pharmaceutical companies or sponsors. They quickly adopt the latest technology, enabling them to offer unique insights and advice, spot new and unique ways of using these advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Some CROs even have their own distinctive technology solutions.

In clinical trials, speed is fundamental and important, especially with pressure on the industry to deliver vaccines during the pandemic within the shortest time possible. Although pharmaceutical firms play a critical role in these clinical trials, the delivery was made possible through the expanded expertise and vast resources brought by partnering with CROs. NonCovid-19 trials were also challenged by the pandemic's restrictions, as patients could not visit hospitals. This was resolved through technology and the rapid virtual trial uptake.

With the increased personalised medicine and the one-size-fits-all model becoming obsolete, combined with the industry drive to make trials more accessible and less burdensome for patients. Today, technology is a key element in clinical trials. CROs are at the forefront of implementing the latest technologies and tools available to maintain competitive advantage and ensure they can offer customers the full spectrum of available solutions. With global CROs working with hundreds of pharmaceutical firms, they have a learning curve and experience breadth beyond any single sponsor. CROs should be considered partners in the drug development process. Sponsors should highly consider a few steps to ensure the partnership runs seamlessly.

Selection:Selecting the right CRO is vital, as each CRO's expertise and reach varies. A thorough evaluation process offers information about the CRO and how it can help a sponsor meet their clinical goals. CROs vary in size, geographical spread, and technical and therapeutic capabilities. Geographical reach or therapeutic focus is important in patient recruitment, particularly if a trial requires a specific population group.

Governance:Establishing an effective governance structure between parties is important to the partnership's success. It should be underpinned by the allocation of roles and proper escalation procedures. As clinical trials are complex, this ensures all parties effectively manage the project scope and stay aligned on the process, deliverables, and expectations.

Success Metrics:A CRO and sponsor should determine how to monitor success to ensure they receive the most from the partnership. Setting performance indicators is a perfect way of ensuring efficiency. Although sponsors enforce specific standards or structures on CROs, embracing another organisation’s standards is less effective than a CRO working to their standards.

Communication:For any partnership, communication is key. Having regular and transparent communication between all parties involved is crucial to avoid most issues.

CROs have played a significant role in the pharmaceutical industry over the past few years and have immensely grown. They are experts in the space, active partners in clinical research, and massive contributors to the industry’s success. Sponsors should adopt these partnerships, and by establishing clear performance indicators, setting standards, and establishing a clear governance structure, they will develop fruitful relationships. Moreover, CROs play a key role in many studies' success and in bringing highly needed drugs and treatments to patients.