how to set up a contract research organization

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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).

Let’s jump in and learn:

• Regulatory Aspects of CROs
• How Contract Research Organizations Work
• Types of Services at Contract Research Organizations
• Pros and Cons of Contract Research Organizations
• Tips for Working with a CRO
• Contract Research Organizations Provide Elasticity

Three criteria for selecting a CRO include:

• 1. Capability
• 2. Compatibility

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)

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.

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
• Biostatistics
• Case report forms
• Clinical monitoring
• Clinical research
• Clinical trial management
• Commercialization
• Data management
• Data research
• Identify and address adverse events
• Formulation development
• Logistics management
• Medical writing, including study documentation
• Pharmacokinetic studies
• Pharmacovigilance
• 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 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
• 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.

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

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Guest Column | June 14, 2018

Cro selection 101 — how to get started.

By Joelle Herman , president, NeoTrials, LLC

This three-part article series will look at how best to procure, manage, and implement best practices in this complicated market.

As companies continue to look for smarter ways to develop drugs, biologics, and devices, outsourcing clinical trials to contract research organizations (CROs) and niche providers continues to grow. A recent report from Statistica projects that global CRO revenues will reach $52.3 billion by 2021 just in locations outside of the Asia-Pacific (APAC) region. While that is impressive, APAC, which is one of the fastest growing markets in the world, is projected to grow at a 20 percent compound annual growth rate (CAGR), compared to 11.4 percent “rest of world” revenue. 1 This growth is substantial and plays into the critical nature of how product developers procure and utilize CROs. This is a complex process whether you are a large biopharma or a small one poised to initiate clinical trials. The complexity of a successful procurement can be managed with good early planning and a strategic approach. 

Champion/Selection Committee

Before you can go out and get bids, the needs of the project/program must be defined by an internal champion or selection committee. A person or team closest to the science or the person responsible for leading the program team or, in a small company, the person managing the clinical trial(s) often are best positioned to lead this effort. A champion will coordinate the entire process across multiple functions (project management, medical, finance, clinical operations, etc.) for the sole purpose of planning the best outsourcing strategy. The champion will ensure a process workflow, define roles/responsibilities, identify challenges (i.e., to eliminate silos or divisions because of competing priorities or lack of vested interest), and ensure goals are defined and agreed to by the selection committee.

A committee that is composed of multidisciplinary leaders often can determine the CRO that is the best fit for the organization. Not all CROs are aligned with your organizational culture, practices, or expertise, so it is a best practice to define these parameters. The selection committee must also have a vested and committed interest in this process. Depending on the size of the organization, the committee may want to define and agree on a communication strategy. This ensures the workflow is moving ahead as per plan and that all members are accountable for their roles and tasks. Additionally, good planning establishes how to maximize core assets and utilize internal resources, supplemented with external resources. A champion and selection committee will define exactly what tasks the CRO will perform and which procedures/processes will govern various tasks. For example, the sponsoring company will establish how the investigator site contracts will be negotiated and who will legally be bound by the agreement(s). CROs bidding on the work need to know exactly what tasks they will perform in order to provide their best approach. With that, the champion/committee will create a specifications document to communicate standard processes, tasks, and tools it is looking to procure. By further defining the scope of the services being procured, whether full service or partial service, companies create a strategic sourcing approach for the clinical trial. 

Procurement/Strategic Sourcing

In order to establish and assess the best fit, the committee may want to utilize its vendor network, current CROs, and/or conduct a competition through public announcement of the procurement.  A competition is not a new concept, but how you conduct the competition is key, especially if the project is partnered with another commercial entity or federal agency (i.e., federally funded). Also, as the committee considers long-term planning or portfolio management, it seems logical to maximize efficiencies with relationship management. How can teams reduce cost and time in this repetitive process? Commercial procurement models generally take one of three forms. The preferred provider model, which creates a more collaborative relationship with a CRO, ensures repeat business and allows for streamlined buying power. The performance-based model or managed services model drives accountability through incentives/penalties using milestones/target achievements. Another model is used when sponsors want to harness innovation to select the best value-added solution. Some CROs have new technology or innovative approaches aligned with the company’s goals to augment internal resources. Making these requirements clear to CROs that range from generalists to specialists with partial- to full-service clinical research functions allows the CRO procurement filter process to be maximized for best fit. What does this mean for the selection committee? What level of detail and criteria are needed?

The request for proposal (RFP) documentation is a vital piece in communicating the sponsor/client’s needs. The RFP will be addressed in Part 2 of this series, but before you can create an RFP, the committee must define criteria for selection. Matching chemistry like perception or perceived value is important on the surface, but the real measures of potential performance are the following criteria.

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Find out more in SAM Sather's webinar:

CRO Oversight Post ICH GCP E6 (R2) Addendum

Selection Criteria For CRO Selection

• Specific therapeutic area and indication experience
• Team member experience in the indication
• Approach to current challenges (demonstrated understanding of enrollment, feasibility, access to KOLs, and investigative sites with the right population and experience)
• Responsiveness and ability to be limber with internal and external processes/systems (don’t forget to conduct a qualification audit as a contingency to an agreement)
• Quality/consistency of performance/financial stability/inspection history 2
• Value (determine the best service for best price)
• Transparency (confirm the scope of service delineates the client will have access to systems)
• Collaboration and communication planning (ask if they have escalation strategies)
• How do they plan (ask for examples of schedules, what plans will be part of the service, i.e., project plans, risk management plan, subcontractor management plan, monitoring plan, statistical analysis plan, data and pharmacovigilance plans)

According to Comprehend, 3 a clinical intelligence software provider, the three most common overlooked selection criteria are transparency, collaborative partnership, and real-time responsiveness. These intangible factors should be part of any strategic selection process. Sponsors struggle to quantify these factors, but to win the business, CROs can proactively demonstrate these intangibles with solid evidence. This isn’t one-sided. CROs can only provide their best services when all parties model transparent and collaborative relationships.

Future articles in this series will cover: developing a CRO selection workflow and checklist, addressing documentation and regulation concerns, and applying best practices to overcome the major challenges in outsourcing.

References:

• https://www.statista.com/statistics/817599/revenue-forecast-for-pharma-cros-by-location/
• https://www.pharmoutsourcing.com/Featured-Articles/172751-What-to-Look-for-in-Selecting-a-CRO-CMO-and-How-to-Ensure-the-Right-Choice-A-Quality-Assurance-Perspective/
• https://www.comprehend.com/overlooked-criteria-in-cro-selection/

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