The growth of the global biotech industry has fueled the need for clinical trial infrastructure that enables the fast execution of high-quality clinical trials. To bring new therapies to market, biopharma companies engage CROs for their expertise in navigating the complex landscape of drug development and regulatory pathway[1]. Emerging biopharma companies, which are relatively smaller than the large global players, are increasingly responsible for a larger share of molecules in the R&D pipeline – a record 65% up from 34% in 2001. In 2021, these emerging companies sponsored 3,386 clinical trials, an increase of nearly threefold in ten years[2].
How to Choose a CRO
The selection of a CRO depends on the experience, areas of expertise, geographical reach, and importantly, ability of the CRO to meet the sponsor’s clinical objectives. For a successful drug development partnership, DeCorte (2020) recommends that sponsors evaluate CROs not just on cost but their intellectual property protection, problem-solving skills, value-creation ability, data integrity, safety and personnel policies, ease of communication, geographical reach, duration of engagement and scalability of capacity[3]. Sponsors needing cost certainty should verify the agreement terms and the CRO’s policy on change orders. An initial bid by a CRO, whether large or small, might not accurately reflect the eventual cost due to subsequent change orders[4].
Benefits of working with a small CRO
Small CROs like Vial offer a high degree of specialization in specific disease areas and geographic focus. To remain competitive and offer clients a full range of value-added solutions, small CROs keep up to date on the latest technologies, techniques and tools in clinical research. As Vial has invested heavily in technology products, partnered with best-in-class research sites, and completed more than 750 trials, it has the breadth of experience that matches or exceeds that of sponsors.
Expertise: Small or niche CROs focus their resources and energies on therapeutic areas and geography to develop in-depth expertise and current knowledge that contribute to the successful completion of clinical trials. In the process, these small CROs also build relationships with investigators and research sites[6]. Taking a step further, Vial established a Site Network that it leverages to provide sponsors with faster, higher-quality trial outcomes that translate to improved project timelines and reduced costs. To date, there are over 35 clinical research sites in the Vial Site Network.
Therapy Experience: Sponsors have a preference for CROs with experience in their targeted therapeutic area(s) and who understand the challenges they will encounter on the path to regulatory approval. Smaller biopharma companies embarking on drug development for the first time may rely on CRO partners like Vial and its expertise in therapeutic areas, to supplement its own capabilities, and to provide tactical and strategic support.
Technology: Small CROs with expertise in niche areas are poised to adopt the latest technologies, identify opportunities for application, and provide insights on how the tech may be deployed to improve clinical trial performance. To this end, some CROs have developed their own unique technology products and services[5]. The Vial clinical trial management system (CTMS), VialConnect is one such example of tech-enabled clinical trials supported by a small CRO. For more information on the tech-enabled capabilities developed by Vial, click on the links below:
- VialConnect is an intuitive clinical trials management platform built for coordinators and investigators whereby all studies, patients, visits, and procedures can be created, managed, and tracked. Digital from start-up to close-out, it allows cross-organizational efficiencies between the sponsor, CRO and sites.
- Vial eSource is a digital system that allows for initial data capture in an electronic source which can be in the form of electronic consent forms, electronic patient diaries, electronic case report forms (eCRF), and clinical outcomes. Built hand-in-hand with world class data management teams, eSource has automated data validation and rigorous query workflows built directly into the platform to ensure the highest quality clinical data.
- Vial eTMF is a seamless file management system with an intuitive workflow for clinical operations teams. eTMF is an electronic Trial Master File which enables structured clinical trial document collection. TMFs are required for good clinical practice.
- Vial Electronic Data Capture (EDC) is an electronic system used to record and maintain subject data in clinical trials and includes a data entry system, validation process, and reporting tools for data analysis. The Vial EDC integrates builds and protocol amendment management as well end-to-end data security.
- Vial electronic patient-reported outcome (ePRO) is a consumer-grade, mobile patient experience that is compliant and customizable for patients in a trial. It is an electronic system that allows patients to directly report the status of their health condition through computers or mobile devices and may be in the form of electronic diaries or questionnaires.
People: In complex clinical trials, sponsors need a CRO team with expertise at all levels and who pay enough attention to detail. Sponsors also have a preference for working with the same people from the start of the trial to its completion. Changes in project manager and clinical research associate (CRA) may result in extended timelines in addition to unanticipated disruption and dissatisfaction at the research sites. Smaller CROs tend to have a much lower turnover compared to large CROs[4], providing the stability and continuity sponsors need.
Culture: In choosing a CRO, sponsors seek CRO partners with a similar corporate culture and value intangibles such as trust, reliability and being proactive in solving issues. Emerging biopharma companies may less prefer having to fit into a large CRO’s system and existing culture of working[1].
Customization: Sponsors express the need for transparency, flexibility, and problem-solving skills from a CRO[1]. Smaller CROs offer more flexibility for customization, and are able to propose and jointly execute out-of-the-box solutions and approaches for projects.
Undivided Attention: For sponsors seeking a high-touch relationship with a CRO, small CROs can offer close contact, good oversight, and a more personal experience. In a partner-like model, small CROs are responsive and mindful of their emerging biopharma client needs[6].
Conclusion
Small CROs are flexible, adopt the latest in technology and are able to customize solutions to meet the needs of sponsors, regardless of their size. Cognizant of the growth in demand for clinical trials by emerging biopharma companies and their unique clinical research needs, small niche CROs also have the experience, expertise, and focus to be valuable partners in their drug development journeys.
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Sources
[1] Constance, J. (2020). Small Biopharma and CROs: Seeking Stronger Synergies. Applied Clinical Trials, 29(9).
[2] The IQVIA Institute. (2022). Emerging Biopharma’s Contribution to Innovation.
[3] DeCorte B. L. (2020). Evolving Outsourcing Landscape in Pharma R&D: Different Collaborative Models and Factors To Consider When Choosing a Contract Research Organization. Journal of medicinal chemistry, 63(20), 11362–11367.
[4] Medelis. Deciding Between a Large CRO and a Boutique CRO for your oncology study.
[5] Forbes. (2021). Contract Research Organizations: Key Partners in the Drug Development Journey.
[6] Medium. (2019). “Boutique” Organizations: How Are They Different & What Do They Offer?
