The medical research landscape is constantly evolving, with new discoveries and breakthroughs emerging frequently. But this rapid innovation comes with a larger workload for biotech and pharma companies as they strive to discover new treatments. To streamline these processes and systematize research, many companies are turning to CROs.
The act of outsourcing clinical research tasks helps a biotech or pharma company save time and money while guaranteeing the completion of its project within the given constraints. The company can also rely on the readily available expertise and experience of a CRO to fuel its research and take it further.
Now – what exactly is a CRO, and what are the benefits of working with one?
What is a CRO?
A contract research organization (CRO for short) acts as a support in the biotech and pharmaceutical industries by providing clinical research services. Biotech and pharma companies outsource different services to a CRO to make their clinical research more efficient.
CROs are not one-size-fits-all – some may offer full services, while others specialize in one particular medical field or one trial phase. The former are larger organizations, while the latter are considered more “niche.” Clients for both can range from biotech startups to big pharma companies.
Some types of CROs include
- Disease-specific CRO
- Clinical CRO
- Preclinical CRO
- Discovery CRO
- Laboratory sciences CRO
Services that CROs offer will range from preclinical research to biopharmaceutical development, to sample and data management. They handle energy-intensive tasks so the company can focus its efforts on other responsibilities.
Vial is an example of a “small” CRO that specializes in specific diseases and geographic focus. Some larger CROs include Proclinical, Ethica CRO, and BioPharma Services.
How CROs Work
A contract research organization is contracted by what is called a “sponsor,” who plays a central role in the clinical trial process. The sponsor will submit an application for the clinical trial to the relevant authoritative body and obtain approval for the trial. They will also finance the trial.
The sponsor will then contract the CRO for its services. This often involves the setup, management, and closure of clinical trials, but more niche CROs will handle one particular phase or service.
The specifics will vary between organizations, but some examples include
- Data collection and management
- Site selection and activation
- Recruitment and onboarding
- Pharmacovigilance
- Medical writing
- Quality assurance
With the clinical trial landscape evolving – and becoming more complex – successfully executing clinical trials becomes an increasingly complicated endeavor. A CRO can handle services such as day-to-day research, designing the clinical trial, or regulatory advising.
Benefits of Working with a CRO
Sponsors primarily outsource their research, management, and clinical trials to a CRO since they themselves have limited resources and expertise to execute these tasks.
#1 — Meticulous site selection
A CRO will have the expertise and know-how to select the appropriate sites for a clinical trial. This requires detailed geographical and demographic knowledge, alongside the ability to match the clinical trial to the optimal location, maximizing the results.
This is especially important when conducting trials and studies in countries outside the location of the sponsor. The company can outsource its research to a local CRO, giving that company a global reach and the ability to market its products internationally.
#2 — Efficient onboarding
Whether onboarding patients or employees, a CRO has the experience, awareness, and attention to detail needed to make the process thorough and systematic. They can train a company’s employees on all protocols and procedures involved in the research, and make sure each employee is briefed on their relevant tasks.
#3 — Streamlined administrative duties
CROs are capable of handling the administrative aspects of a clinical trial, as they are equipped with thorough knowledge of relevant regulations and policies. It’s part of their practice to remain updated with these protocols so they can ensure full compliance and avoid any penalties.
Sponsors can contract a CRO to take care of the necessary paperwork for a clinical trial, alongside other management tasks such as recruitment support and regulatory affairs.
#4 — Systematic patient recruitment
A qualified and capable CRO is meticulous and thorough when it comes to its recruitment plan. It can scout a diverse participant pool and screen patients per the eligibility criteria to meet the trial’s requirements. The CRO will also mandate informed consent to ensure the patient is fully knowledgeable about the trial, its processes, and the related risks.
#5 — Effective communication
Clinical trials come with a variety of risks that can be compounded by ineffective communication. CRO’s are ClinOps specialists who can mitigate these risks by effectively managing communication between the teams and organizations involved at every stage of the trial.
#6 — Optimized workflow
Because CROs have the necessary staff, experience, and equipment for clinical trials, they can optimize the workflow of the trial. The CRO can design the clinical trial and omit any extraneous or unnecessary steps while working quickly and systematically on each phase.
Many clinical trials are time-sensitive. CROs are built to begin working from the get-go, minimizing any time lost in the early stages of the trial. There will be no delays in any step of the process, from hiring, fundraising, or lab preparation. The CRO will have established standard operating procedures (SOPs), so it can execute its responsibilities with confidence.
#7 — Readily available resources
A clinical trial is a complex combination of project management and patient care. A sponsor or startup might not have the correct resources to handle these tasks, but a CRO already has these in place, whether it’s manpower or laboratory equipment.
The best CROs keep abreast of technological developments in their fields and leverage these resources in their services. These tech-enabled organizations help reimagine the landscape of clinical trials by providing best-in-class services powered by innovations.
Some examples of modern technologies that clinical trials use are intuitive management platforms, file management systems, data capturing systems, and patient feedback systems.
CROs and Clinical Trials
A contract research organization brings more than just manpower to a biotech or pharma company’s clinical research. It provides expertise, resources, cost-effectiveness, and custom data. A quality CRO will seamlessly provide clinical research services faster, better, and cheaper – while ensuring transparent and verified results.
The Vial CRO
Vial is a next-generation, industry-leading CRO powered by technology that delivers faster, more efficient clinical trials for biotech sponsors. Between our fixed-fee pricing model, experienced team, and modern technology platform, we drive efficiencies in all areas of a clinical trial. If you want to learn more about Vial’s end-to-end clinical trial services, contact us today!
