Biotech Contract Research Organization

Biotech Contract Research Organization

What is a biotech CRO?

A biotech contract research organization (CRO) provides research services primarily to pharmaceutical, biopharmaceutical, and biotechnology companies. Services include bioanalytical studies, clinical trial oversight and management, safety, and regulatory support. Within clinical trials, a sponsor (the organization developing a new treatment) hires a biotech CRO for specific projects. CROs provide the expert guidance, advice, and execution experience required to complete clinical trials safely and efficiently — without the sponsor having to hire a full-time study team.

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

Larger CROs may serve both pharmaceutical and biotech companies. Many specialty CROs cater specifically to biotech companies. Biotech companies are typically small and agile. They often lack the space for a large lab, they don’t have a large roster of clinical research sites to draw from, and they lack the manpower to effectively manage a complicated global clinical trial. A biotech CRO provides some or all of these resources.

How do biopharmaceutical clinical trials work?

Once researchers have done initial testing on a promising treatment in a lab, they must initiate a clinical trial to prove it’s safe and effective before they can offer it to the public. A biotech CRO will conduct the trial in successive phases (Phase I, Phase II, and Phase III). As each phase of the trial progresses, sponsors learn more about the effectiveness, risks, and side effects of a treatment.

Biopharmaceutical clinical trials — which include studies for cell and gene therapies, biologics, and immunotherapies — function similarly to trials for regular drugs. However, the criteria used to evaluate participants may include whether an individual has a specific gene mutation. If the study is treating a rare disease, it will likely include fewer patients. Biopharmaceutical studies are typically held in select academic research centers where physicians and clinicians have experience with the type of therapy being studied.

Biotech contract research organization roles and responsibilities

A biotech CRO is responsible for planning, setup, and day-to-day execution and management of its contracted clinical trial, particularly data collection and medical testing. It must stay in compliance with regulatory agency guidelines and follow Good Clinical Practice (GCP) standards. Think of the biotech CRO as the hub that connects the sponsor with other stakeholders such as regulatory agencies, ethics committees, academic research centers, genome engineering companies (for gene therapies), and specialty labs, among others.

What is a biotech CRO in clinical trials?

In clinical trials, a biotech CRO plans, develops, and coordinates the clinical trial protocol (i.e., the master plan). The CRO then executes that protocol in accordance with regulatory agency rules and GCP standards. A sponsor — usually a biotech or pharma/biopharma company — contracts with a CRO to oversee their clinical trials. An experienced biotech CRO offers valuable scientific and technical services and consulting. The CRO can also help the sponsor avoid expensive missteps and delays, which helps the sponsor move their product through clinical trials much faster.

What does a biotech-specialized contract research organization do?

Biotech CROs provide a wide range of clinical research services to biotech 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
  • Regulatory Support

It’s important to note that many of these services are more complex for biopharmaceuticals than with other medicines. That’s why biotech companies should look for CROs with extensive experience in this field.

Types of specialty contract research organizations

CROs range in both size and scope. Some CROs offer end-to-end services and have access to research sites worldwide. Others focus on early- or late-phase clinical trials, while others specialize in certain therapeutic areas. A few specialty niches among CROs generally include:

  • Discovery
  • Preclinical
  • Clinical
  • Laboratory Services
  • Health Economics Outcomes Research (HEOR)
  • Decentralized Clinical Trials (conducted either fully or partially virtual)
  • Cell and Gene Therapy
  • Complex Disease

Frequently Asked Questions:

Who is the sponsor in biotechnology clinical research?

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

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

A biotech CRO provides clinical research services to biotech and biopharma companies. A biotech CRO may also work with pharmaceutical and medical device companies. A biotech CRO often has scientific capacity and expertise that other CROs do not, such as experience in developing immuno-oncology tissue culture and assays.

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.

Biotech and biopharmaceutical companies research and develop biologic medical products. These products are manufactured in or derived from biological sources. Products include vaccines, gene therapies, cell therapies, recombinant therapeutic proteins, and immunotherapies, among others. Once a biotech company confirms it has a potential therapy, it contracts with a biotech CRO to either start clinical research or oversee later phases of research.

What is the advantage of partnering with a biotech-focused contract research organization?

Biotech CROs oversee clinical trials and other aspects of therapy development so sponsors can focus on what they do best — innovation. Delegating clinical research, data management, and project management functions to a CRO is a necessity for many biotech companies. All these processes are highly complex, and biotech companies often lack the people, facilities, and connections to manage these tasks effectively and efficiently on their own. By outsourcing to a CRO, they gain a true partner for their clinical trials.

What is the role of a biotech CRO?

A biotech CRO acts as an extension of a biotech company’s team. They make sure all aspects of therapy development — including clinical trials — happen on time and within budget. They monitor all the data produced by clinical trials to make sure it matches study requirements. A biotech CRO’s industry experience and technological capabilities allow it to spot and resolve any glitches or mistakes before they become serious problems.

How to choose a biotech CRO?

A biotech CRO should deliver the right combination of experience, expertise, communication, and responsiveness. Understanding your therapeutic area, your type of therapy, and what to expect from your trial 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 biotech CRO is one of the most important decisions a sponsor can make when getting ready to start a clinical trial. Take into consideration the CRO’s experience in relation to your project, as well as its communication style and overall expertise as you weigh your decision.

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.

Contact us today to learn how our biopharmaceutical experts and clinical data management team can help bring your next clinical trial to life.

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