What is a contract research organization? A contract research organization is also known as a clinical research organization or a CRO for short. A CRO’s defining characteristic is to provide clinical trial management services for the biotechnology, pharmaceutical, and medical device industries. A CRO’s experience, knowledge of a trial’s disease, patient recruitment tactics, quality management, communication, technology, and pricing are all critical factors to consider when selecting a CRO to manage a clinical trial. Typical CRO services include regulatory affairs, clinical trial design and management, site selection and startup, participant recruitment and site support, monitoring, data management and logistics, medical writing, and general project and vendor management. CROs support various therapeutic areas such as oncology, amongst others.
The global oncology contract research organization (CRO) market is projected to grow in line with the international clinical trials market. A recent study estimates the global clinical trials market to be US$35.1 billion in 2022 and projects growth at a compound annual growth rate (CAGR) of 9.1% to reach US$54.3 billion in 2027. In 2021, Phase III clinical trials had the largest share (53.4%) of the clinical trials market, and North America had more than half the global market share (50.7%). Key drivers include a shift towards patient-centric clinical trials, improved clinical trials due to CRO consolidation, and increased industry research and development (R&D) expenditure. Additionally, the globalization of clinical trials, harmonization of regulations, and the increasing need for developing new drugs for chronic diseases have contributed to market growth.
Oncology Clinical Trials
The global market for cancer treatment, estimated at US$161.3 billion in 2022, is projected to reach US$209.2 billion by 2026 (growing at a CAGR of 7.1%). The U.S. market (38.3% of the global total) is projected to reach US$52.4 billion in 2026. Findings of recent studies:
- The impact of COVID-19 on cancer care: Oncology caseloads are 20-29% lower, and more new patients present with metastatic disease compared to pre-COVID-19. IQVIA estimates that over 30 million cancer screenings were affected, contributing to the risk of late or missed diagnoses for more than 58,000 patients.
- Spending on oncology medicines rose to $185 billion globally in 2021 and is projected to exceed $300 billion by 2026. The US remains the most significant market globally. IQVIA reports that the pipeline of next-gen biotherapeutics has considerable potential. However, there is also uncertainty, both clinically and commercially.
- Diagnostics and companion diagnostics drive global Immuno-Oncology Diagnostics Market growth. Diagnostics, especially biomarkers, are needed to provide information to help select the corresponding treatment.
- Pharma increasingly forges strategic partnerships with AI vendors, including a $3 billion collaboration between Bristol Myers Squibb and Century Therapeutics and a $1.2 billion acquisition of Amunix Pharma by Sanofi for immuno-oncology.
Key findings from analyses conducted by IQVIA
- Innovation: In 2021, a record number of 30 oncology novel active substances were launched globally, while 83 unique new cancer medicines were launched in the US alone in the past five years.
- R&D: In 2021, oncology trial starts reached historically high levels (up 56% from 2016), with most trials focused on rare cancer indications, and emerging biopharma companies were responsible for 68% of the oncology pipeline. Early cancer trials and vaccines have more than doubled in the past decade.
- Bringing scientific advances to cancer care: the introduction of novel cancer therapies to patients across the globe is uneven, with differences in biomarker testing rates, adoption of novel therapies, and infrastructure capacity to deliver advanced therapies.
Top 10 Oncology CROs
Oncology CROs help contribute to proper drug development research and aid sponsors in achieving FDA approval for treatments and medical devices. Below we have compiled ten of the current leading oncology CROs for efficiently running oncology clinical trials.
ICON was founded in Dublin, Ireland, in 1990 and is a global provider of drug and device development and commercialization services in Europe, the US, South America, the Middle East, and Africa. ICON’s Oncology CRO services span the lifecycle of product development and commercialization, serving small local trials and large global programs. As of September 30, 2022, ICON employed approximately 41,150 employees in 113 locations in 53 countries.
The ICON Oncology CRO supports clinical trials for early-phase oncology, immuno-oncology, and cell and gene therapies; for both solid and hematological tumors. Sponsors can avail themselves of ICON services which include
- medical imaging
- site and patient recruitment
- real-world intelligence resources and expertise
- digital solutions to increase efficiency and drive site performance
- laboratory services for clinical development
- consulting on market access and pricing strategies.
Founded in 1982, IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the combined industries of health information technologies and clinical research. Today, IQVIA is among the top and largest CROs and has approximately 85,000 employees in operations in over 100 countries.
IQVIA Oncology CRO provides sponsors with services and support from trial design to commercial optimization. These include:
- trial design and delivery include patient recruitment and support for sites
- therapeutic expertise and demonstrating the value of oncology treatments during the regulatory submission process
- access to IQVIA’s non-identified data from more than 15 million oncology patients worldwide
- access to data assets across different geographies
- support for commercialization through IQVIA’s combined oncology expertise, data, analytics, and technology.
Labcorp is a leading global life sciences company that provides diagnostic, drug development, and tech-enabled solutions for more than 160 million patient encounters annually. Deeply integrated with guiding patient care, Labcorp provides insights and accelerates innovations in healthcare. It has over 70,000 employees worldwide and supports clinical trial activity in approximately 100 countries.
The Labcorp Immuno-oncology and Oncology CRO provides preclinical oncology discovery services, clinical trial development, and diagnostic test services. Oncology clinical trial capabilities include trial development for targeted oncology and hematology therapies and precision medicine. From 2017 – 2022, the Labcorp team was involved in over 975 oncology studies (of which 300 were immuno-oncology studies) with over 104,000 oncology patients in 19,000 sites across 83 countries. In addition, Labcorp has supported over 70% of all FDA-approved companion diagnostic products[12,13].
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. 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.
Medpace provides specialized Hematology and Oncology CRO services, including developing novel therapies strategies, planning for and running studies, competing for high-performing global sites, accelerating study start-up and recruitment, and navigating the global regulatory landscape. The Medpace team has experience conducting research for the full range of therapies, from classic to cutting edge, and the flexibility to manage small, focused trials and extensive, global studies.
One of the largest CROs, Parexel, supports the development of innovative new medicines to improve patients’ health. Parexel is a global CRO providing clinical development capabilities and integrated consulting expertise, with international study locations in the US, UK, and Germany. To expand access to patient populations and increase diversity in clinical trials, Parexel launched its Community Alliance Network in 2022. In collaboration with CVS Health and Javara, the novel program integrates clinical research into the community healthcare setting.
The Parexel Oncology Center of Excellence (COE) provides clinical, consulting, and operational expertise to support clinical development in all types of cancer. Therapeutic classes include molecularly targeted agents, immunotherapies, cellular and gene therapies, antibody-drug conjugates, novel cytokines, and radiopharmaceuticals. The approach combines an early advisory service of medical, regulatory, genomics, and biostatistical experts with a multi-disciplinary team (with academic, regulatory, and industry backgrounds and direct clinical experience). Parexel describes its strengths as having
- a dedicated therapeutically aligned team with experience and expertise across multiple indications, drug types, and trial designs
- innovative approaches, including adaptive designs
- expertise in precision medicine, real-world data, and decentralized trials
- established investigator and site relationships
- a culture of caring – for investigators, sponsors, and patients .
PPD was established as a one-person consulting firm in 1985 and has since conducted clinical trials in more than 100 countries. PPD has over 30,000 employees and is a leading global CRO providing comprehensive, integrated drug development, laboratory, and lifecycle management services. In December 2021, Thermo Fisher Scientific acquired PPD for $17.4 billion.
Equipped with the latest patient-centric technologies, PPD Oncology CRO’s dedicated oncology teams help sponsors navigate complex oncology trials by
- leveraging adaptive trial designs
- using biomarker-driven randomization to target subjects
- optimizing country mix based on factors like clinical development phase, protocol complexities, standards of care, patient population, and regulatory environment. The PPD Immuno-oncology COE has conducted 135 immuno-oncology trials involving over 38,000 patients at more than 5,000 sites worldwide. PPD Laboratory services, which support trials at every phase, contributed to the development of 24 out of the 25 best-selling oncology drugs of 2020.
7. 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. 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 is part of Precision Medicine Group, founded in 2012, and has over 3,000 people in 40 locations in North America and Europe today.
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. Oncology CROs like Precision for Medicine offer services that cover the discovery, development, and commercialization of personalized medicine in oncology and hematology. To meet the needs of next-generation targeted therapies in oncology, Precision for Medicine has aligned its services to execute complex clinical trials efficiently. As of December 9, 2022, 51% of oncology trials were international, 65% were of adaptive design, and over 80% had immuno-oncology endpoints.
8. Syneos Health
Formed through a merger between INC Research and inVentiv Health, Syneos Health is a global biopharmaceutical solutions organization that includes a CRO and a Contract Commercial Organization (CCO). Syneos Health designed its business model to accelerate customer success by strategically blending clinical development, medical affairs, and commercial capabilities. Syneos Health has a team of over 29,000 supporting operations in more than 110 countries.
The Syneos Health Oncology CRO provides services for targeted therapies, novel and emerging therapies, and immuno-oncology. The targeted therapies focus include biomarker-driven therapies, biosimilars, antibody-drug conjugates, and other small molecules. Syneos Health refers to its close ties with patient advocacy organizations, investigator cooperative groups, and key opinion leaders (KOLs) combined with the use of big data among its strengths. The Syneos Health Novel and Emerging Therapies group focuses on hematology-oncology, non-malignant hematology, and cell and gene therapy. In contrast, the Immuno-oncology group focuses on treatments that stimulate the immune system to combat cancer. In the last five years, Syneos Health has supported 202 immuno-oncology studies involving over 23,000 patients worldwide.
9. 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 clinical study management and tech-enabled CRO services. The Vial Oncology CRO’s team has extensive experience leading clinical trials across indications and is supported by a group of scientific advisors with expertise across therapies in immuno-oncology. The CRO’s executive team works closely with expert site operations teams to continuously review execution strategies, monitor patient recruitment efforts, and mitigate key study risks for oncology clinical trials.
- Patient Recruitment. Vial’s tech-enabled recruiting platform enables accelerated patient recruitment using a multi-channel marketing strategy, scalable patient qualification and scheduling, and pre-screening for faster enrolment.
- Site Activation. Powered by its robust technology platform and team of expert operators, Vial has onboarded 90% of its sites in less than 30 days.
- Vial Technology Platform. Vial delivers faster, more efficient trials by empowering clinical operators with powerful clinical trial technology. Vial’s technology platform brings clinical trials from paper to tech-enabled streamlined processes in an end-to-end system.
- Vial Preferred Site Network. Vial has built solid and long-lasting relationships with highly experienced, sought-after sites across the globe, knowing that quality investigators are at the core of successful clinical trials. The Vial Preferred Site Network connects dedicated sites to leading sponsors for more streamlined trials that bring new therapies to market faster. Each site in the Vial Preferred Site Network has undergone a comprehensive selection process. Vial ensures every site is equipped for streamlined trial execution via tech-enabled processes from site start-up to database lock.
10. 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 for 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. 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. Further, Worldwide has received recognition from respected industry associations and awards programs.
Worldwide’s dedicated oncology team, which includes members previously involved directly in clinical research, provides phase- and indication-specific expertise and tailors support regardless of project size or complexity. Worldwide also promises to deliver on-site feasibility and selection and patient engagement. A dedicated team of medical monitors and global project leads are tasked with relationship-building and maintaining communication with sites. To expedite recruitment, Worldwide partners with indication-specific recruitment experts to find the right patients for the right trials and places .
- Business Wire. (2022, September 28). Clinical Trials Market Research Report 2022: Shift Towards Patient Centric Clinical Trials Driving Growth.
- Business Wire. (2022, June 27). Clinical Trials Market Size, Share & Trends Analysis 2022-2028 by Phase (Phase I, Phase II, Phase III, Phase IV), & Indication.
- Business Wire. (2022, August 3). Global Cancer Therapies Market Research Report 2022.
- Business Wire. (2022, June 1). Global Oncology R&D Surges While Cancer Care Disruptions Ease, Says IQVIA Institute for Human Data Science.
- Business Wire. (2022, June 8). Global Immuno-Oncology Diagnostics Market Forecasts 2022-2026: Explosion in Immuno-oncology Therapies Creates an Exploding Diagnostic Market.
- Business Wire. (2022, June 7). Pharmaceutical Drug Development Sector Scorecard 2022.
- ICON. (November 2, 2022). ICON Reports Third Quarter 2022 Results. ICON.
- Oncology. ICON.
- IQVIA. (October 26, 2022). IQVIA Reports Third-Quarter 2022 Results. IQVIA.
- Embrace innovation. Accelerate oncology breakthroughs. IQVIA.
- History. Labcorp.
- Oncology & Hematology Clinical Trial Development. Labcorp.
- Immuno-oncology & Oncology. Labcorp.
- Medpace 2021 Annual Report. Medpace.
- Hematology & Oncology. Medpace.
- Oncology & Hematology. Parexel.
- PPD Company History. PPD.
- Thermo Fisher Scientific. (December 8, 2021). Thermo Fisher Scientific Completes Acquisition of PPD, Inc. Thermo Fisher Scientific.
- Oncology and Hematology Clinical Development. PPD.
- Forward thinking enables breakthroughs. Precision Medicine Group.
- Next-Gen Oncology CRO Services. Precision for medicine.
- Syneos Health. (December 1, 2022). Syneos Health Releases 2023 Health Trends. GlobeNewswire.
- Oncology and Hematology. Syneos Health.
- The Oncology CRO Built for Sponsors Powered by Technology. Vial.
- Awards & Accolades. Worldwide Clinical Trials.
- About Us. Worldwide Clinical Trials.
- The Right Trials, Patients, and Places for Meaningful Oncology Research. Worldwide Clinical Trials.