The evolving needs of the global biotech industry necessitate a clinical trial infrastructure that enables the fast execution of high-quality clinical trials that, at times, require the expertise, people, culture, customization, and undivided attention small contract research organizations (CRO) can offer. Regarding changes in clinical trials, precision medicine requires new approaches in study design and the evolution of randomized clinical trials (RCT); and real-world evidence has a role in assessing the external validity of RCTs. From the point of view of a biotech sponsor, clinical teams are conceptualizing new approaches to RCTs for new medicines for high-morbidity diseases.
Emerging biopharma companies, 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. 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, rather preferring small CROs.
COVID-19 silver lining. The pandemic greatly impacted new study launches (an estimated 43% reduction in Q1 2020) and simultaneously revealed that there is flexibility in the clinical trial system, which can be explored. Sponsors and the U.S. FDA introduced guidelines that enabled clinical trials to continue during the pandemic e.g., electronic consent and tech-enabled participant engagement. Scientists weighed the benefit of these flexibilities against the potential impact on the quality of research. Small CROs like Vial recognized the need to evolve and have built on their experience in managing best-in-class research sites to reimagine and recreate next-level tech-enabled clinical trials that, most importantly, maintain quality of research.
The Small CRO Promise
Small CROs offer a high degree of specialization in specific disease areas and geographic focus. Small CROs keep current on the latest technologies, techniques, and tools in clinical research to remain competitive and offer clients a full range of value-added solutions. To see how small CROs are a better match on expertise, therapy experience, technology, people, culture, customization, and giving undivided attention, do visit Benefits of Working with a Small CRO. Below, we have compiled a list of the top five small CROs on the rise.
Medelis is a specialty full-service oncology CRO focused on Phase I – IV oncology trials with a presence in North America and Europe. Founded in 2003 by a team of experienced clinical research oncologists, Medelis provides sponsors with oncology expertise and manages complex oncology trials in all indications. Since 2008, it has also been working with sponsors on developing clinical strategies and study execution for immuno-oncology therapies. In 2016, Medelis announced a merger with WCCT Global, bringing its oncology expertise and experience in designing and managing trials in North America and Europe. The Medelis clinical operations team has managed over 425 clinical trials and over 200 oncology studies.
Medelis offers a partner-like approach with a dedicated project manager for a trial and promises rapid service with short lead times, supporting sponsors with contingent resources to meet unforeseen needs, fast upscaling and downsizing, and no additional headcount, amongst others.
Founded in 1992, Medpace aims to accelerate the global development of safe and effective medical therapeutics across all major therapeutic areas. A mid-size, full-service global CRO for drugs, biologics, and medical devices, Medpace is engaged in scientifically-driven outsourced clinical development services across a range of therapeutic areas for the biotechnology, pharmaceutical, and medical device industries. Its customer base includes small, mid-sized, and large biopharma companies. To remain competitive among full-service CROs, Medpace describes its strengths as having deep therapeutic expertise in areas that are among the largest, most complex, and fastest growing in pharmaceutical development, having a global platform, and having an experienced and committed management team. To date, Medpace has over 4,800 associates across 41 countries.
For the first nine months of 2022, ending September 30, 2022, Medpace revenue was $1,065.9 million, increasing 27.8% on a reported basis and 29.3% on a constant currency organic basis from the same period in 2021. Medpace aims to continue expanding its market share in the Phase I-IV CRO market with emphasis on oncology, metabolic disease, cardiology, antiviral and anti-infective (AVAI), and central nervous system (CNS).
Precision for Medicine
Precision for Medicine is a global precision medicine CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. Precision for Medicine is part of Precision Medicine Group, which was founded in 2012 and has over 3,000 people in 40 locations in North America and Europe today. Offering an integrated solution of trials, labs, and data sciences, Precision for Medicine seeks to deliver more predictable trial outcomes, accelerated clinical development and approval, and ultimately new life-changing treatments for patients worldwide.
Precision for Medicine supports life sciences companies in using biomarkers to target patient treatments more precisely and effectively and applies novel biomarker approaches to clinical research. Since 2013, interdisciplinary teams at Precision for Medicine have worked on advancing clinical, regulatory, manufacturing, and commercial strategies for innovative cell and gene therapies. In 2022, it received four awards from the Clinical Leader and Life Science Leader’s 2022 CRO Leadership Awards – an annual recognition based on feedback surveys of biopharma sponsors.
Vial Health Technology Inc.
Founded in 2020, Vial is a next-generation CRO on a mission to disrupt the clinical trials industry with best-in-class study management and tech-driven CRO services. By mid-2022, Vial raised more than $100 million in total venture funding and, in November 2022, announced that venture firm General Catalyst had led a $67 million Series B fund of financing for Vial.
Vial’s mission is to raise the clinical research industry to the next level – to be less reliant on pathways and processes which are now defunct – and to mirror the speed and progress that its biopharma partners demand of their innovations in healthcare. Vial has built a team of ClinOps executives from leading CROs and Silicon Valley technology leaders to achieve its mission. To successfully deliver a premium CRO experience, Vial is reimagining the very nature of clinical trials and distinguishing itself by leveraging its technology platform to deliver dramatically faster and more efficient trials for sponsors. The Vial technology platform replaces paper source in trials, supports productivity-enabling workflows, and is HIPAA, GDPR, and CFR P11 compliant.
Reimagining Clinical Trials. The Vial technology platform integrates trial onboarding, patient enrolment, site communication, and data collection processes into one connected system:
- Vial Site Startup App enables sites to seamlessly onboard to trials, as evidenced by 90% of sites being onboarded in under 30 days.
- Electronic Source
- Vial eSource allows real-time, intuitive data capture with built-in conditional logic and validation, is easy to use, and reduces site protocol deviations. eSource enables the shift to Centralized Monitoring and lower-cost geographies resulting in up to 50% cost savings
- Vial EDC: From the CRA and project manager (PM) perspective, running a complex global trial from the Vial dashboard is more manageable as it allows complete visibility into all sites at every level and ensures process adherence.
- Vial eSource Builder has dramatically reduced build times by approx. 40% reduction in timeline compared to legacy eCRF (electronic case report form) translations and builds; a one-day turnaround of initial, pre-quality assurance build; and two weeks end-to-end build flow timeline.
- Centralized monitoring has resulted in approx. 20% cost reduction
- Automation of CRAs/PMs has resulted in approx. 10% cost reduction
- Patient Recruitment Platform recruits patients across over 15 channels and converts them to randomizations, reducing enrolment periods. Pre-screening team pre-qualifies prospective patients and schedules subjects’ screening visit
- Fixed-price agreements with no change orders. Vial offers sponsors flat-rate pricing, zero change orders, risk-share on commitments, and accountability on commitments.
Worldwide Clinical Trials, Inc.
Founded by physicians dedicated to advancing medical science, Worldwide Clinical Trials, Inc. (Worldwide) is a mid-size, full-service global CRO that strategically balances science, medicine, operations, and commercial intelligence in providing clinical research solutions. In addition to having a global reach, Worldwide describes its strengths as therapeutic specialization, methodological rigor, the ability to link experimental design to operational imperatives, and providing flexible, transparent, and integrated systems. Further, Worldwide has received recognition from respected industry associations and awards programs. Based on direct survey feedback from biopharma professionals, Worldwide has been recognized as a high-performing CRO by the 2022 CRO Leadership Awards for nine consecutive years.
In January 2022, Worldwide announced its partnership with Science 37, which specializes in supporting virtual trials. To grow its early-phase, large-molecule capabilities, and services, Worldwide announced in August 2022 that it is expanding its services with a new large-molecule laboratory in Austin, Texas.