Contract Research Organization
A contract research organization (CRO), also called a clinical research organization, is a service business that provides outsourced clinical study and clinical trial support to life sciences companies. CROs also support non-profit organizations, foundations, research institutions, universities, and government and non-government organizations.
CROs specialize in consulting services for pharmaceutical, biotech, and medical devices. They range from large, international, full-service organizations to small, niche, specialty businesses.
Contract research organizations provide life sciences companies with experience and expertise for parts of or all of the work required to move a drug or medical device from ideation through regulatory approval processes (e.g., Food and Drug Administration or FDA, European Medicines Agency or EMA).
Three criteria for selecting a CRO include:
- 1. Capability
- 2. Compatibility
- 3. Cost
Regulatory Aspects of CROs
In some cases, CROs assume responsibility for regulatory aspects of a clinical trial or clinical study. Sponsors may transfer any or all clinical trial tasks and obligations to CROs through a Transfer of Regulatory Obligations (TORO). Based on obligations detailed in a contract, the regulatory aspects of CROs include being held responsible for any sponsor obligations it assumes for studies conducted under an investigational new drug application.
Regulations and guidelines set forth by both the FDA and ICH-GCP define how sponsors engage with CROs and associated responsibilities.
Food and Drug Administration (FDA)
Code of Federal Regulations - Title 21 - Food and Drugs (21 CFR)
Sec. 312.52 Transfer of obligations to a contract research organization.
- A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing.
If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract research organization. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Any obligation not covered by the written description shall be deemed not to have been transferred.
- A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to "sponsor" in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor.
International Conference on Harmonization (ICH)’s Good Clinical Practice: Consolidated Guideline (ICH-GCP)
- (5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
- (5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).
- (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
- (5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.ICH-GCP (E6 1.20) definition of a Contract Research Organization (CRO)
How Contract Research Organizations Work
Life sciences companies increasingly engage contract research organizations to complement, augment, or use in place of internal teams. By outsourcing this function, drug or device sponsors do not have to maintain and manage staff for key functions, including discovery, preclinical, clinical, and laboratory services. How contract research organizations work with sponsor organizations varies by project.
Three ways that sponsor organizations commonly use contract research organizations are:
- 1. Maximum outsourcing
The CRO is used for nearly all of the clinical development activities.
- 2. Strategic outsourcing
The sponsor conducts phase I and early phase II studies, and the CRO is engaged to conduct follow-on studies.
- 3. Tactical outsourcing
Sponsors use the CRO for individual studies or specific parts of a study.
Types of Services at Contract Research Organizations
Contract research organizations offer everything from end-to-end, full-service offerings to niche services focused on a particular type of work or distinct therapeutic area. Some sponsors use CROs to initiate and monitor clinical trials, while others have them take responsibility for running the trial in its entirety.
Following are several of the many types of specific services available from contract research organizations.
- Biologic assay development
- Biopharmaceutical development
- Case report forms
- Clinical monitoring
- Clinical research
- Clinical trial management
- Data management
- Data research
- Identify and address adverse events
- Formulation development
- Logistics management
- Medical writing, including study documentation
- Pharmacokinetic studies
- Preclinical research
- Preparation and submission of regulatory materials
- Project management
- Protocol design
- Recruitment support
- Regulatory affairs
- Sample selection
- Site management
- Site selection and activation
- Stability programs
- Trial logistics
Pros and Cons of Contract Research Organizations
Pros of Contract Research Organizations
- Allows sponsors to focus on their core business
- Bring proven people, processes, and equipment to support all phases of trials
- Come prepared to start work as soon as a contract is signed—no delays related to hiring or set up
- Know the best clinical sites and investigators in a specific region to ensure high patient enrollment rates
- Offer experience and local knowledge of regulations and approval processes in a variety of nations and locations
- Provide ready access to resources needed to conduct a clinical trial
- Saves sponsors money ramping up for and running clinical trials
Cons of Contract Research Organizations
- Exposure to significant regulatory risks because sponsors are ultimately responsible for the quality and integrity of the trial data
- Have to conduct multiple audits before and during every step of the trial
- Lack of direct oversight with a team that is in another location
- Requires sharing intellectual property and other confidential information with an outside organization
Tips for Working with a CRO
- 1. Agree on performance metrics to measure progress and quality.
- 2. Clarify roles and responsibilities—specify which tasks will be performed in-house and which by the CRO.
- 3. Clearly define realistic timelines for start, duration / end data, as well as timing for key milestones.
- 4. Conduct audits throughout the study.
- 5. Create an accurate and detailed list of activities required to initiate, conduct, analyze, and report the results of a clinical study.
- 6. Define content and format requirements for various reports (e.g., status reports, interim analysis reports, final report).
- 7. Establish communication channels and protocols between internal teams and the CRO’s teams.
- 8. Assign dedicated internal resources to manage the study.
- 9. Identify key contacts on both sides.
- 10. Treat the CRO as a partner.
Contract Research Organizations Provide Elasticity
CROs have become a fundamental part of clinical trials because they offer a wide range of services to support all phases. Sponsor organizations have the option of outsourcing studies to CROs or using point solutions to fill gaps or leverage unique expertise.
The CRO’s knowledge and experience can help sponsors reduce workload and expedite trials. Partnering with contract research organizations has proven beneficial to life sciences organizations of all sizes.
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Last Updated: 10th October, 2021