The Growing Role of CROs in Clinical Trials

In today’s environment, drug developers must decide whether to leverage a CRO partner even earlier in their development timelines.

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform.

As clinical trials become more complex, sponsors are seeking business partnerships with a congruency in the management and prioritization of pipeline.

In our conversations with biopharma and biotech organizations over the past year, it’s become increasingly evident that the rising number of clinical trials and economic climate mean that the industry is feeling the effects of resource constraints.

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints.

How a CRO accelerates clinical development

Clinical trials are becoming increasingly complex as the industry evolves. Our recent survey on industry trends found that 51% of drug developers denote the increasing complexity of clinical trials as a top challenge, along with patient recruitment (55%) and regulatory hurdles (46%).

From oncology clinical research to vaccine development, successfully executing and overseeing the many moving parts of a clinical trial may become overwhelming for sponsors to handle alone.

Undoubtedly, a CRO’s ability to respond to increased urgency by assuring certainty and speed in project delivery is the gold standard. Surveys show that CROs improve trial efficiency and increase productivity.

As a trusted extension of a drug developer’s team, CROs have the capacity to complete the day-to-day research activities that are either not possible or too expensive to achieve in-house. That can range from designing the clinical trial itself to bioanalytical testing and regulatory consultation.

CROs in action

In today’s competitive landscape, with early decision and engagement, CROs enable their customers to navigate and overcome challenges.

Here are some examples:

• A European biotech firm with a promising pipeline and large investments needed to ramp up across multiple functions and therapeutic areas. The organization sought to build a dedicated FTE model for a broad range of services, including regulatory, medical writing and data management. It tapped a CRO with a strong FSP program to consolidate and streamline resourcing, and in doing so reduced time-to-offer from more than 50 days to 36.
• A sponsor needed a reliable laboratory partner to deliver product characterization and stability registration data for two different inhaled drug-device combination products. While this may have been too expensive or impossible to complete in-house, partnering with a knowledgeable and experienced CRO in this area provided both the capacity and the harmonized, quality data needed for successful new drug application (NDA) submissions.
• Amid a pause in clinical studies during the pandemic, sponsors needed a way to ensure trial continuity while keeping patients safe. Forward-thinking CROs used their experience, operational capabilities and regulatory knowledge to quickly deploy innovative, digital strategies — such as a visual communication tool to facilitate investigator and patient interaction — to safely continue data collection.

Four key factors to consider when selecting a CRO partner

Our experts see greatest sponsor success when they carefully consider the following factors in their CRO partner.

1. A partnership model. A partnership model includes early engagement and shared governance with the CRO to prioritize and co-manage the pipeline. This brain trust extends to creative problem-solving, the ability to lean on global capabilities together, and a consistent and engaged team — translating to consistency and better prioritization of a sponsor’s trials.
2. A talent retention and retraining strategy. Seek out CROs that invest in their people. Research suggests that companies that prioritize education become talent magnets and report increased retention rates. Sponsors considering an outsourcing or functional service provider (FSP) model, in particular, should look for a CRO that prioritizes developing staff knowledge and skillsets. The full force of global training, upskilling and reskilling, and mastery of data, infrastructure and systems encourages lower turnover and, in turn, study stability.
3. Agility and scalability. Ensure the CRO can adapt its services and speed to your specific needs and goals, both today and in the future. If breaking into new geographic markets is an objective next year, will a given CRO be stable and sizeable enough to enable that? It’s also smart to partner with a CRO that can extend beyond traditional services and stay on the cutting edge — whether that’s early involvement with mRNA vaccines or trial decentralization.
4. Experience and capabilities. Clients will initially interact with the business development team. Don’t be afraid to go a step further by ensuring the potential project team and leaders have relevant indication or product experience. Has the company worked with projects or drug products similar to yours before, and does it have the integrated global capabilities to provide support for your study? CROs should also be able to supply a list of client references or customer testimonials to demonstrate its ability to accelerate development.

These factors are, of course, coupled with the non-negotiables in a CRO partner: dependability, diversity, a patient-centric approach and collaborative engagement.

A strong CRO partner is prepared to navigate the explosive R&D landscape alongside you.

CROs bring more than just reassurance to drug developers’ clinical programs — they also provide a wealth of expertise, drive time and cost efficiencies, and deliver outstanding project management.

By choosing a CRO that is committed to operational excellence, customers gain more than clinical trial capabilities — they secure a valued partner with a shared commitment to the success of their clinical program.

More than a third of biotech respondents in our 2023 report, The Pulse: Global R&D Insights in Pharmaceuticals, are feeling the strain of talent shortages. As a result, 41% have increased their reliance on CROs though FSP partnerships.