Contract Research Organizations (CROs) have been making revolutionary breakthroughs in medicine possible for half a century. In 2024, their outsourced support in critical research activities, from clinical trial design to patient recruitment, is more important than ever.
The role of CROs in the biotech, pharmaceutical, and medical devices industries – once an advantage, today a necessity – has greatly expanded over the past few years.
Big pharma companies and, especially, emerging biotech firms are increasingly relying on CROs for trial success. As the demand for innovation grows, CROs are cementing their position as key industry players shaping how treatments are discovered, tested, and delivered.
What Is a Contract Research Organization?
A contract research organization (CRO) is a third-party provider of critical services, infrastructure, and resources for therapy research, development, and outsourced clinical trials in medicine. They are hired by pharmaceutical, biotechnology, and medical device companies to plan, manage, monitor, and execute trials, ensure regulatory compliance, and bring new treatments to market.
It’s a complex role that changes on a project-by-project basis, and may involve a full range of research and development activities from the beginning to the end of a clinical trial, or several specialized services in a specific trial phase, depending on the sponsor’s needs and budget.
In addition to full-service and specialized providers, the CRO market also includes two types of “clinical research organizations”: ones that conduct preclinical, nonclinical research and clinical trials, and the others that only conduct clinical trials, either in full or only partially.
All CROs, whether they define themselves as contract or clinical research organizations, must follow the strict guidelines outlined by regional regulatory bodies like the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK’s Medicines and Healthcare Products Regulatory Agency, as well as international authorities for cross-border clinical trials.
What Does a Contract Research Organization Do?
Clinical trials are incredibly complex – a typical discovery-to-approval process takes 10-15 years. CROs are sometimes hired for the full duration, and other times their help is needed for a specific phase, domain, or service. But what does a contract research organization exactly do?
All CROs, regardless of specialization, perform these core functions:
Clinical Trial Planning
CROs help design trial protocols, define objectives, and select trial sites. They also calculate sample sizes, outline inclusion/exclusion criteria, and assess trial feasibility to make sure there are no timeline challenges or logistical constraints.
During Phase 3 of its COVID-19 vaccine trial, Moderna contracted PPD (now Thermo Fisher Scientific) for its expert support in protocol development.
Regulatory Affairs Support
One of the CRO’s core functions is preparing and submitting the paperwork needed for approval from authorities like the FDA or EMA and helping sponsors understand and follow standards like Good Clinical Practice (GCP).
BlueRock prepared the IND submission for the FDA and helped Veristat pass the complex cell therapy guidelines in their legacy Parkinson’s disease trial.
Site Management
CROs have the required knowledge and connections to select, secure, and run a trial site in different countries, including staff training and getting approvals from local boards.
In partnership with the Rare Disease Advisory Committee (RDAC), PRA Health Sciences integrated site management with patient-centric strategies to address the unique challenges of rare disease clinical trials.
Data Collection & Analysis
By tracking patient data, managing case reports, and running statistical analyses, CROs collect, clean, and analyze all the data from a clinical trial – like ICON did for Pfizer’s COVID-19 vaccine trials. With ICON’s help, Pfizer was able to speed up reviews and regulatory decisions.
Safety Monitoring
Patient safety is a top priority in clinical trials, so it must be monitored closely and continuously. CRO’s have the right systems in place to track side effects and respond to potential safety signals. This function also involves reporting to stakeholders and collaborating with review boards.
Types of CROs
Every CRO is distinct. As clinical research grows more complex, so do their roles and specializations. Many different types of contract research organizations have emerged to address unique sponsor requirements, ranging from therapeutic expertise to geographic reach:
Full-Service vs. Specialized CROs
Full-service contract research organizations provide end-to-end support to clinical trial sponsors, from pre-clinical research to post-marketing surveillance. These CROs are regularly contracted for complex clinical trials that demand global coverage, but they are also valuable partners to emerging industry firms that lack the necessary infrastructure, expertise, and connections.
Under “specialized contract research organization services”, CROs imply specific therapeutic areas such as oncology, rare diseases, etc, or separate segments of the research process like biometrics, regulatory consulting, and early-phase trials. These contractors are more suitable for larger firms with developed in-house infrastructure that require help with a certain part of the trial.
Global vs Regional CROs
Global CROs run trials across multiple countries and understand the nuances of different regulatory environments, but don’t have the local knowledge needed for granular insight. They’re best suited for sponsors and studies that demand consistent execution on a global scale.
On the opposite end of the spectrum are regional CROs, which concentrate on specific regions and offer local expertise and contacts needed for agile development and fast approval. They are a better choice for sponsors trying to penetrate new markets or conducting localized studies.
Functional Service Providers (FSP)
Functional Service Providers (FSPs) are a special type of CROs that provide targeted support in specific areas, such as data management or monitoring. These contractors usually work together with the lead CRO to help efficiently scale resources without expanding existing staff.
Types of Contract Research Organizations: Overview
| CRO Type | Service Scope | Most Suitable For | Examples |
| Full-Service CROs | Complete trial management | Sponsors that need end-to-end support | ICOn, Labcorp, Parexel |
| Specialized CROs | Therapeutic areas or functional domains | Sponsors seeking specific expertise | Veristat, Medpace, CliniRx |
| Global CROs | Multi-country operations | Large, multinational studies | IQVIA, Syneos Health, ThermoFisher |
| Regional CROs | Country or region-specific | Local or emerging market trials | Tigermed (Asia), KCR (Europe) |
| FSPs | Specific trial functions | Sponsors requiring flexible resourcing | PSI CRO, Cytel |
Contract Research Organization Services
CROs cover a broad set of clinical outsourcing services, including:
- Protocol Development: Designing the clinical trial plan to meet scientific, regulatory, and operational requirements.
- Regulatory Submissions: Preparing and submitting documentation to regulatory authorities to gain trial approval.
- Site Selection & Management: Identifying qualified clinical sites and overseeing their operations.
- Patient Recruitment & Retention: Developing strategies to enroll and keep participants engaged until the end of the study.
- Medical Writing: Creating essential documents (study reports, protocols, regulatory submissions, etc).
- Monitoring: Ensuring trial integrity and patient safety through regular site visits and data review.
- Clinical Data Management & Biostatistics: Collecting, cleaning, and analysing trial data to support accurate study outcomes.
- Trial Master File (TMF) Support: Managing and maintaining all essential documents to ensure regulatory compliance and audit readiness.
- Imaging, Labs & Pharmacovigilance: Tracking and reporting adverse events to meet regulatory safety requirements.
- Project Management: Coordinating resources, timelines, and communication to keep the trial on track.
In keeping up with the increasingly complex trial and market demands, many CROs today offer advanced services such as decentralized trial support, AI-driven analytics, and real-world data integration, on top of the well-established outsourced trial services sponsors expect.
How Sponsors Work with CROs
Choosing the right CRO is a challenging, multistep process that involves careful evaluation of several key factors, such as expertise, past performance, pricing transparency, and cultural fit. Experienced sponsors often send a formal Request for Proposal (RFP) with a predefined project scope, objectives, and required services, which helps them evaluate CROs based on compatibility.
Sponsors and CROs must also agree on the level of the CRO’s involvement in research and development and specify the phase, domain, or specific part of a clinical trial for which the contractor will be hired. The sponsor-CRO partnership has three different oversight models:
Full Outsourcing
Inexperienced and emerging sponsors often opt to fully outsource clinical trials to CROs. In this model, the CRO is responsible for everything from protocol design and site management to data analysis and reporting. This gives them full control, but also full accountability.
Hybrid Model
The hybrid model allows sponsors to outsource only those parts of the trial that they need to and still retain full control over the process. It’s the best approach for larger companies with in-house expertise and infrastructure that require assistance on an as-needed basis.
Functional Service Provider (FSP) Mode
Some CROs provide dedicated support for specific trial activities, such as monitoring, biostatistics, or data management. This is an excellent option for sponsors that lack a certain expertise or technology resources, but don’t want to contract a CRO for the long term.
Regardless of the model, collaboration between a sponsor and a CRO requires a firm foundation built on communication and transparency. Project clarity is of utmost importance, particularly in terms of scopes, objectives, deliverables, and timelines. When every aspect is defined with precision, there’s less room for protocol deviation and delays, which ensures optimum results.
Oversight tools and dashboards are often used for project tracking and real-time rapport between CROs and sponsors. Project collaboration technology plays a vital part in maintaining transparency, but it’s also crucial when unpredictable obstacles threaten project success.
Market Overview
The global CRO market was worth more than $80 billion in 2024. Experts estimate steady growth, mainly due to increasing research and development costs and the demand for faster time to market. The fact that regulations guiding clinical trials are becoming more and more complex creates additional demand for capable CROs. Aside from that, key growth drivers include:
- Biotech innovation and frequent breakthroughs in advanced new treatments like cell and gene therapies, mRNA platforms, and personalized medicine require niche expertise and flexible trial design to strike a balance between speed and quality.
- Decentralized trials are rethinking standard protocol design and replacing physical trial sites with digital tools for remote tracking. Wider accessibility, easier patient recruitment, and lower costs are key benefits of decentralized trials managed by CROs.
- Small sponsor outsourcing is surging along with the number of emerging biotech and pharma companies. These small businesses thrive on innovative research and development, but they don’t have in-house resources to conduct complex trials.
Thanks to these drivers, the contract research organization market is expected to grow at a CAGR of over 6% by 2023, according to Market Research Future. CRO involvement is critical in all the fastest-growing segments, from oncology and gene and cell therapy to rare disease research. Market analysts expect increasing CRO specialization and collaboration in the following years.
Notable CROs
Unlike in biotech and pharma, where small up-and-coming game-changers are rising to prominence, the CRO market is dominated by major global players like Thermo Fisher Scientific, ICON plc, Labcorp, PPD (part of Thermo Fisher since December 2021), and Syneos Health.
These industry giants have something in common: they all offer comprehensive services that cover all trial phases and therapeutic areas. Being well-established on the market, they already have the scale and infrastructure needed for large, multinational clinical trials.
In addition to big CROs, which mostly offer full outsourcing services, market analyses also recognize a growing number of smaller CROs that focus on specialized services and work with biotech innovators. They are most dominant in niche areas of oncology, rare diseases, gene and cell therapy, or biometrics, where they provide deep expertise and flexible trial support.
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Today, clinical trials are becoming more global, complex, and resource-heavy; leading CROs are the only organizations that can guarantee trial success on this scale. The role that specialized contract research organizations play in smaller trials should not be underestimated either. In both cases, their involvement can reduce costs, speed up delivery, and ensure compliance.
These benefits are nowhere more obvious than in smaller biotechs. Without CROs, these companies would not be able to turn drug research into real-life solutions.
If you need help selecting or managing a CRO, contact TMClinical for expert oversight and guidance across your clinical development journey.