The Growing Role of CROs in Clinical Trials
In today’s environment, drug developers must decide whether to leverage a contract research organization (CRO) partner even earlier in their development timelines. Check out four key factors to consider when selecting a CRO partner, from the editors of the Insights Hub at PPD, part of Thermo Fisher Scientific.
It’s estimated that nearly three out of every four clinical trials today are conducted by contract research organizations (CROs), highlighting just how much sponsors value – and rely on – the work that CROs perform. Meanwhile, 2021 was one of the best years on record for biotech, as venture capitalists increased investments into the biotech sector by 60 percent in January 2021 compared to a year prior.
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 biotech organizations over the last several months, it’s become increasingly evident that the rising number of clinical trials – and increasing popularity of outsourcing to CROs – means that the industry is feeling the effects of resource constraints more than ever before.
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. 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.
CROs support the pharmaceutical, biotechnology and medical device industries through research services based on a contractual agreement between the sponsor and the CRO – and 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 resource challenges.
Here are some recent examples:
- A large pharmaceutical organization was leading a critical and time-sensitive COVID-19 therapeutic program. The organization needed its study startup timeline to be incredibly short without sacrificing the detailed tracking of patient specimens. By utilizing a CRO, study startup began in less than 10 business days. In addition, the CRO initiated a formalized oversight process to safeguard irreplaceable SARS-CoV-2 samples, providing the sponsor with enhanced chain of custody at every step.
- 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.
- 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.
Four Key Factors to Consider When Selecting a CRO Partner
PPD’s experts see greatest sponsor success when they carefully consider the following factors in their CRO partner.
- 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.
- 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 taps into a single talent pool for both functional-service partnerships and full-service engagements. The full force of global training, upskilling and reskilling, and mastery of data, infrastructure and systems encourages lower turnover and, in turn, study stability.
- Agility and scalability. Ensure the CRO can provide the services and speed required for your specific study, 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.
- Experience. 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? CROs should also be able to supply a list of client references or customer testimonials to help inform decision-making.
These factors are, of course, coupled with the non-negotiables in a CRO partner: excellent customer service, communication and quality.
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 customized, high-quality data.
By choosing a CRO that is committed to operational excellence, customers gain more than clinical trial capabilities – they secure a valuable partner with a shared commitment to the success of their clinical program.