Contract research organizations (CROs) can be excellent assets for companies in the biotech, pharmaceutical, or medical device industries. But what can a CRO actually bring to your company, and when should you enlist the services of a CRO? Let’s take a look at what a contract research organization is, the services offered by CROs, the benefits of CROs, and how to choose a CRO that meets your clinical study’s needs
- What is a contract research organization (CRO)?
- What does a contract research organization do?
- What services does a clinical research organization provide?
- What are the benefits of a CRO?
- How to choose a Contract Research Organization
- CRO services with Gsap
What is a contract research organization (CRO)?
In short, a contract research organization (CRO) is a company or business that offers support for clinical studies in the biotech, medical device, or biopharma industries. CROs are experts in clinical trial execution, their experts include different disciplines such as CPMs – Clinical Project Managers, CRAs – Clinical Research Associates, Medical Writers, Data Managers etc., thus they can help companies, businesses, or institutions (usually referred to as trial “sponsors”) reduce the costs and often lengthy timelines associated with a clinical study.
What does a contract research organization do?
Now that we’ve addressed what a CRO is, let’s take a look at what a CRO does. A clinical research organization is hired by a clinical trial sponsor and is then responsible for the planning, management, and execution of the entire clinical trial.
The role of a CRO and its assigned team is to ensure that a clinical trial is performed to the highest standards, according to the guidelines and regulations, to ensure the participant’s safety is maintained and that all data is robust and accurate. At the same time, the clinical research organization is responsible for performing the trial efficiently and as cost-effectively as possible.
What services does a clinical research organization provide?
The CRO acts as the main point of contact and coordinates between the sponsor and other stakeholders in the clinical trial, including regulatory bodies, ethics committees, physicians/medical staff, research coordinators, and vendors.
Specific services typically offered by a clinical research organization include:
● Study planning and design
● Medical writing of study protocol and other core documents
● Study feasibility, start-up, and document preparation
● Site selection and activation
● Regulatory submissions and contracts
● Site management and clinical monitoring
● Data management, data analysis and biostatistics
● Clinical trial Project management
● Interim and final study reports
● Quality assurance (QA) and audits
Contract research organizations (CROs) have the skills and knowledge required to run a successful clinical trial and ensure that all elements of the trial are compliant with local and international requirements.
What are the benefits of a CRO?
There are a lot of advantages associated with a contract research organization. The most important include:
Expertise and experience
Most sponsors looking to undertake a clinical trial do not have experience in all of the areas listed above. Therefore, teaming up with a CRO that has the resources, personnel, and experience needed to execute a successful trial offers a much simpler and more streamlined approach to conducting a clinical trial.
Cost-effectiveness
Another major benefit is cost reduction. A clinical research organization that can keep a clinical trial running according to a pre-determined schedule can save the sponsor significant financial burdens associated with delays to the trial.
Meeting the technological needs of the trial
Clinical research organizations have the needed infrastructure and are equipped to meet the clinical and technological requirements of a clinical study, when a sponsor may otherwise not have been able to. This could relate to everything from SOPs, Clinical Trial Management System, subject enrolment tools, to data collection system, biostatistical and data management programs.
Time-saving
If a sponsor was required to create or obtain everything necessary to run a clinical trial, this would take years to commence. A clinical research organization already has all these necessary resources, meaning that a trial can get up and running significantly faster with a CRO for healthcare.
Navigating evolving and complex regulatory requirements
Clinical trial regulatory requirements are ever-changing, complicated to navigate, and often region-specific. A contract research organization can coordinate with regulatory personnel and ensure that necessary approval from the relevant regulatory bodies is obtained prior to the start of the trial. Throughout the trial, a CRO ensures all regulatory requirements are adhered to.
How to choose a Contract Research Organization
Depending on the requirements of a specific clinical trial, a sponsor may have a large number of seemingly suitable contract research organizations to choose from. When assessing which CRO is the best for your specific needs, consider the following factors:
● Is the CRO responsive, communicative, and collaborative?
● Does the CRO have relevant experience?
● Do they have an established quality system and QA processes?
● Is there a high turnover of clinical research associates (CRAs), or is staffing stable?
● What are the services the CRO offers?
These questions, along with others specific to the nature of your clinical trial, will help you find a CRO that gives you the peace of mind that your trial management is in safe hands.
CRO services with Gsap
Gsap is a full-service CRO with significant experience in the design and execution of clinical trials. Whether running an early-phase PK study, or an advanced-stage clinical trial, Gsap can provide the support you need to ensure success each step of the way.
A boutique CRO offering personalized support
Gsap is a boutique CRO, which means that you have more than just an organization to manage your trial – you have a partner you can work with every step of the way. Gsap delivers undivided attention to sponsors, both large and small.
Broad experience across multiple disciplines
Gsap’s CRO services span a diverse array of disciplines, including medical devices and digital health. Gsap also specializes in the rapidly growing field of medical cannabis, as well as cell and gene therapy, and the development of new pharmaceutical drugs and biologics.
End-to-end clinical trial support
Gsap is able to provide services that cover all the stages of a clinical trial. Before your trial commences, Gsap offers study design, planning, regulatory submissions, and site selection services. When a trial is wrapping up, Gsap delivers study reports, closes out study sites, and analyzes the associated trial data and writing interim and final reports.
Customized clinical trial services
By design, no two clinical trials are identical. Therefore, Gsap tailors its clinical trial services to each sponsor, to ensure the needs of your specific trial are met, based on your product’s characteristics and the geographical location(s) of your trial.
Gsap has helped numerous clients successfully manage the transition from pre-clinical development to clinical studies and can support your trial from start to finish. The Gsap holistic approach to CRO services helps to ensure the success of your own clinical trial.
Contact Gsap today to discuss your upcoming clinical trial.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager