The CRO as Strategic Partner 10 Aug 2022
CROs (contract research organisations) have been an integral part of the drug development landscape since they emerged in the 1970s. Initially early CROs such as Quintiles provided additional capacity to pharmaceutical companies on a largely transactional basis, evolving from niche offerings to a range of services across the product life cycle including drug discovery, pre-clinical, clinical trials, and post-marketing studies.
In the past, pharmaceutical companies typically conducted most of their operations with in-house resource, retaining centres of excellence across distinct functions. Over time, the paradigm shifted along with a trend towards greater outsourcing across other industry verticals such as IT. Other drivers such as R&D productivity issues, increase in the number of smaller biotech companies with limited in-house resources, and a drive towards cost containment have led to an uptake of Drucker’s principle, ‘Do what you do best, and outsource the rest,’ with sponsors turning to outsourcing at scale.
Over the last 50 years, as well as growing to offer a greater breadth of services, CROs have taken up a more strategic role in research often collaborating extensively with pharmaceutical companies across various aspects of their pre-clinical, clinical and post marketing requirements to enable success.
In contrast to the transactional role of the past, where CROs would be given tasks to accomplish, modern CROs have built up a wealth of knowledge to enable faster, more efficient, clinical trials, making the most of advances in technologies, analytics, wealth of data, and innovative trial designs.
Pharmaceutical sponsors choose to work with CROs using a variety of models, depending on their strategic requirements, ranging from long-term multi-programme engagements, to single studies.
In ‘full-service’ outsourcing, pharmaceutical sponsors would outsource all the operational aspects of their clinical trial to a single CRO from biostatistics to clinical monitoring. This approach often works well for smaller organisations outsourcing a small number of studies, especially where they are complex in nature and benefit from straightforward contracting approaches.
Functional outsourcing is becoming an increasingly popular model where functional expertise is key, for example in biostatistics and statistical reporting, or where talent attraction is a bottleneck such as for CRAs. This model is widely used within larger organisations where opportunities exist for functional efficiencies across programmes of work. This model can be beneficial not only in cost savings, but in building knowledge and efficiencies over time. It also allows sponsors to retain control over their outsourcing often to a greater extent than with the full-service approach.
Other approaches include specialist outsourcing – which outsources on a study-by-study basis but rather than using a full-service model, brings together 2 or more CROs to deliver based on competency. For example, contracting with a clinical CRO based on their specialist therapeutic expertise, and a data management and biostatistics provider to ensure data consistency can deliver the best of both worlds, but may need greater sponsor oversight.
No matter the model, one area where CROs are making their mark is through harnessing technology to deliver more effectively in the context of real-world data, advanced analytics and decentralized and hybrid trials.
Indeed, in the modern clinical trial landscape CROs are seen as strategic partners whose proven agility makes them valuable players in enabling pharmaceutical companies to realize the opportunities of digital innovation and deliver new medicines to patients faster.
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