Contract Research Organization

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Contract Research Organization

What is a CRO?

A contract research organization range of clinical research services to (CRO) provides research services to pharmaceutical, biotechnology, and medical device companies. Services can range from drug discovery to commercialization, pharmacovigilance to post-approval services. Within clinical trials, a sponsor (the organization seeking to investigate the safety and efficacy of a new treatment) hires a CRO on a contract, project-by-project basis. CROs provide the expert guidance, advice, and execution experience required to complete clinical trials safely and efficiently — without the sponsor having to hire such staff on a full-time basis.

How do Clinical Trials Work?

Once researchers have done initial testing on a promising treatment in a lab, they must initiate a clinical trial to prove its safety and efficacy before being allowed to market it to the public. A CRO will conduct the trial in successive phases (Phase I, Phase II, and Phase III). The first step is to enroll clinical trial participants — who must meet certain criteria depending on the intended patient profile of the specific trial — and who may be compensated for their time. As each phase of the trial progress, more is learned about the effectiveness, risks, and side effects of a treatment.

Contract Research Organization Roles and Responsibilities

A CRO is responsible for planning, setup, and day-to-day execution and management of its contracted clinical trial. Handling and supervising the technical side — data collection and medical testing — comprise a significant portion of its tasks. It is important to note that clinical compliance with regulatory agency guidelines is crucial, and adhering to Good Clinical Practice (GCP) standards is part of the CRO’s role as it acts as the trial’s central hub, connecting the sponsor with other stakeholders such as regulatory agencies, ethics committees, vendors, hospitals, etc.

What is a CRO in Clinical Trials?

In clinical trials, a CRO is the entity that plans, develops, and coordinates the clinical trial protocol. Then, it executes that protocol in accordance with regulatory agency rules and GCP standards. A sponsor — who might have many potential treatments they wish to have tested via clinical trial — engages a CRO to take care of the time-consuming and resource-intensive work required of a clinical trial. The sponsor is able to leverage the expertise of the CRO, which due to the CRO’s repeated execution of trial after trial, comes to be able to anticipate potential delays and pitfalls, avoiding them ahead of time.

What Does a Contract Research Organization Do?

CROs are able to provide a wide range of clinical research services to medical sponsors, including, but not limited to:

  • Project and Data Management
  • Clinical Study Oversight and Execution
  • Research Education and Compliance
  • Medicine and Disease Coding
  • Validation Programming
  • Product Development Planning and Commercialization
  • Safety and Efficacy Reporting
  • Quality Analysis
  • Biostatistical Review
  • Statistical Analysis
  • Medical Writing

Types of Contract Research Organizations

Different CROs can offer varying services, but they are most commonly grouped by where their contribution falls on the sponsor’s research timeline, along with the CRO’s primary function:

  • Discovery
  • Preclinical
  • Clinical
  • Laboratory Services

Frequently Asked Questions:

Who is the sponsor in clinical research?

The sponsor is the organization that initiates a clinical trial in order to investigate the safety and efficacy of a potential treatment. The sponsor partners with a CRO and the CRO manages and executes the sponsor’s clinical trial.

What is a CRO company?

A CRO company is an organization that offers its services to pharmaceutical, biotechnology, and medical device companies to assist them in various forms of research. Some CROs are focused specifically to work with sponsor companies of a particular size. For example, Synteract focuses on the SMID market, or small to mid-sized biopharmaceutical companies.

What is the difference between a CRO and a pharmaceutical company?

Pharmaceutical companies develop drug treatment candidates intended for eventual commercialization. Once such a treatment is ready to be tested in a clinical trial environment in order to prove to regulatory authorities that it is both safe and effective, a pharmaceutical company will partner with a CRO. The CRO will then plan, coordinate, and execute the clinical trial.

Benefits of contract research organizations

A primary benefit of CROs is that they allow sponsors to do what they do best — focus on treatment development — while CROs take care of the nuts and bolts of clinical trial planning and execution. Given the extensive resources and processes required to safely and efficiently conduct a clinical trial — including data collection, project management, and daily patient care — delegating these functions to a CRO who already has these established systems is an attractive solution for many sponsors.

What is the role of a contract research organization?

A CRO acts on behalf of a sponsor and is in charge of making their clinical trial run smoothly. A CRO replaces what would otherwise be a sponsor’s expensive and only intermittently needed in-house team. Management and execution of every clinical trial function — especially for those sponsors who only infrequently need to conduct clinical trials — would be cost- and resource-prohibitive.

What metrics should contract research organizations use?

CROs employ different metrics to measure efficiency and progress depending on the goals and expectations of sponsors and the limitations of GPC and regulatory frameworks. There are three basic timelines that merit attention and evaluation:
  • Sponsor Draft Budget Received to Budget Finalized
  • IRB Submitted to IRB Approved
  • Full Contract Execution to Open Enrollment

What is an early-stage contract research organization?

Clinical trials take place in phases, generally Phase I, Phase II, and Phase III. If a drug fails to meet safety or efficacy milestones at any point in these successive phases, it cannot proceed to the next phase. An early-stage CRO focuses on the earlier-stage phases (primarily Phase I, sometimes Phase II).

How to choose a CRO?

A CRO should be able to deliver the right combination of experience, expertise, communication, and responsiveness. Understanding your therapeutic area and what to expect from your trial’s phase is key. Transparency is also important — being able to address potential issues early in the process, in a collaborative fashion, can mean the difference between milestones met and unnecessary delays.

Choosing a CRO is one of the most important decisions a sponsor can make when getting ready to start a clinical trial. Understanding the role and function of a CRO, understanding the factors to weigh when choosing a CRO, and knowing what to realistically expect from the CRO you choose all need to be taken into consideration.

About Synteract

Synteract®, a Syneos Health® company, is a leading full-service CRO focused on the emerging biopharma segment. The Company's multidisciplinary teams support biotech and pharmaceutical companies across all phases of drug development, providing deep expertise in oncology, dermatology, general medicine, infectious disease and vaccines, neuroscience, pediatrics, and rare and orphan diseases. Synteract has conducted nearly 4,000 studies on six continents in over 62 countries. Contact us today to learn how our team of experts can help bring your next clinical trial to life.

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