A CRO, or Contract Research Organization, is an outsourced service provider that manages clinical trials. CROs are designed to help make research more feasible. It should then come as no surprise that CROs are involved in an estimated 70% of all clinical research.

What types of services are offered by a CRO?

Services provided by a CRO can range widely, from pre-clinical services to post-marketing surveillance, and depends on the type of CRO. A full-service CRO can offer all the services associated with conducting a clinical study, including:

• Pre-clinical services
• Feasibility assessments
• Participant recruitment
• Project management
• Regulatory dossier and ethics submissions
• Phase I, Phase II-III, and Phase IV Clinical Trial Management
• Site Selection
• Trial Monitoring
• Pharmacovigilance
• Statistical Analysis
• Medical Writing

The benefits of outsourcing clinical research

Operating clinical research is expensive both in terms of overhead costs (such as equipment, clinical space, etc.) and human resourcing needs. CROs help to reduce these costs by providing the resources necessary to conduct a clinical trial as soon as a contract is in place. Even if a company has the capital necessary to invest in the resources necessary to conduct research, timing may be a limiting factor.

Types of CROs

While there are many types of CROs, most fall into 2 main categories:

1. Generalized CROs: these types of CROs offer a full range of services from early-phase to post-marketing surveillance support to sponsors
2. Specialized CROs: these types of CROs focus on a specific niche. For example, certain CROs may specialize in early-phase research, have more competency for indication-specific research (e.g. diabetes), or focus on specific verticals such as medical devices or nutraceuticals.

Things to consider when choosing a CRO

Not all CROs are created equal. Some things to consider when selecting a CRO are:

1. Experience: Does the CRO have experience conducting clinical trials with your specific indication? How long has it been in service? Are there gaps in the expertise provided by the CRO’s staff?
2. Access to population: does the CRO have access to a population that can meet your participant recruitment needs?
3. Regulatory oversight: is the responsible regulatory authority a member of the International Council for Harmonization? How long do clinical trial applications take?
4. Quality management: what type of quality management systems is in place? How is personal data protected? How does the CRO handle protocol deviations?
5. Pricing: in addition to the service rate, you should consider how the CRO bills for things like protocol amendments and other activities beyond the scope of the original signed agreement

About us

dicentra Clinical Trials is a leading Canadian CRO with unparalleled experience, operating clinical trials across several product categories including medical devices, therapeutics, cosmetics, functional foods, dietary supplements & natural health products, and much more. We offer full-service CRO capabilities in both Canada and the United States to support your research goals. Discover the dicentra advantage. Contact us today.