What is a CRO? – A contract research organization is a company that provides research services to the biotechnology, medical device, and pharmaceutical industries. The services of such a company range from biopharmaceutical development and clinical trial management to preclinical research. A contract research organization has many benefits for its clients. One of the most important is that they can keep costs down and deliver high-quality services. Read More: What is a CRO?
Clinical trial management
Contract research organizations (CRO) provide a wide range of services to pharmaceutical companies and other clinical trial sponsors. Their expertise includes research, statistical analysis, site management, and thought leadership. They also provide data management. Some CROs specialize in one specific area, such as a single type of trial or a range of therapies.
A CRO can make or break your clinical trial. As a result, it is critical to understand its role in the clinical trial process and how to choose the right one for your study. When choosing a CRO, consider factors such as staff expertise, quality system processes, and cost. A good CRO can help you achieve your goals and keep your trial on track.
A CRO acts on behalf of a sponsor and is responsible for the smooth running of the clinical trial. This can save a sponsor money and resources since they don’t have to hire an in-house team. Clinical trials can be time-consuming and resource-intensive, so it makes sense to hire a company that is specialized in clinical trial management.
A CRO provides a wide range of services for pharmaceutical, biotechnology, and medical device companies. These services can range from clinical trial initiating to monitoring and post-approval services. Using a CRO saves the sponsor critical time during the trial phase. Additionally, it helps reduce the overall length of a trial. A CRO will have the necessary expertise, tools, and resources to effectively complete a clinical trial.
CROs also provide access to advanced systems and technology
This allows the hiring company to take advantage of new developments in technology. For example, the CRO can conduct monitoring remotely. Approximately 76% of sponsors already conduct most monitoring remotely. And 83% of sponsors expect this trend to be widespread by 2023.
The services of a CRO can be tailored to the specific needs of the sponsor. The organization can provide support for the entire process, or work alongside the sponsor’s internal team to provide guidance and oversight. Many CROs also have specialized services, such as rare disease and oncology trials.
In recent years, more local CROs have emerged, bringing greater competition to the market and reducing costs. This presents a business opportunity for these firms, but poses a challenge for global CROs that conduct trials in many different countries. Therefore, international CROs must adjust their pricing policy accordingly and maintain high quality standards in the trials they carry out.
Bio-pharmaceutical development
Outsourcing bio-pharmaceutical development services is a popular strategy for pharmaceutical companies, as it speeds up the development process and reduces cost. This approach also increases the speed to market and commercial success of products. As a result, outsourcing is driving up M&A in a variety of segments of the outsourced pharmaceutical services industry, including contract research organizations. These companies offer specialized manufacturing and clinical research capabilities that are of interest to both investors and strategic buyers.
Several large contract research organizations provide services across a broad range of biopharmaceutical development activities. For example, ICON, a leading global provider of outsourced development services, provides services from compound selection to Phase I-IV clinical trials. ICON has 98 offices in 38 countries and employs 13,250 people. Another contract researcher is Wuxi AppTec, which offers an integrated portfolio of manufacturing and laboratory services.
Read also: 5 Ways to Lower Your Risk of Cancer
Contract research organizations can be academic or commercial
Regardless of its role, contract research organizations are increasingly partnering with life sciences companies to complete their trials. They provide services that augment, supplement, or even replace internal teams. These contract research organizations specialize in the execution of clinical trials, allowing the sponsor to focus on other aspects of the development process. While the sponsor conducts phase I and early phase II studies, the contract research organization handles follow-up studies and data analysis.
Bio-pharmaceutical contract research organizations (CRO) specialize in preclinical, clinical, and regulatory studies. These organizations typically offer a wide range of services, including bio-analytical studies, clinical trial oversight, safety, and regulatory support. They are generally hired by a sponsor for specific projects, and they deliver expert guidance, execution experience, and advice. This way, the sponsor avoids the expense of employing a full-time study team.
Contract research organizations provide services to the biotech, pharmaceutical, and medical device industries. CROs range in size from large international full-service organizations to specialized niche groups. These organizations have the expertise and experience needed to speed the development of a new drug or medical device to FDA approval.
Contract research organizations also perform research support services
Their expertise and resources allow them to offer multiple services to a variety of industries. They can save a client significant amounts of time in the trial phase, which speeds up the development process. In addition, they are already equipped with the tools and resources needed to conduct a clinical trial.
The cost of service is an important factor in the total cost of drug development. However, it should be viewed as secondary after other primary criteria. Moreover, small and mid-sized companies will likely prioritize cost over other factors. As a result, it is vital to look beyond the cost of a CRO’s services and focus on recruiting top talent. Ideally, CROs should hire bio-pharma veterans who can act as true strategic clinical-development partners.
Preclinical research
Preclinical CROs specialize in helping new medical product developers prove the efficacy and safety of new medical products in live models. These models must closely resemble human anatomy to comply with FDA guidelines. The best preclinical CROs have GLP certification and AAALAC certification, and comply with the Animal Welfare Act. They also understand the science behind their customers’ studies and have high-quality biomedical engineers on staff. They also have the expertise to support sponsors during different stages of clinical development.
A leading CRO in preclinical research, Pharmaron has developed an advanced information system to provide clients with accurate project traceability. The company has secured seven of the world’s largest pharmaceutical companies as clients. Its expertise in biotechnology, animal welfare, and regulatory affairs has helped numerous clients advance their projects into clinical trials.
CROs can be a vital asset for drug discovery
Their multidisciplinary experts can test drugs in a variety of animal models and save companies time and money. This can be particularly important if multiple animal models are required. Additionally, a CRO can ensure that all documentation is accurate and thorough. This makes the process of drug discovery much easier.
Although many CROs operate on a small scale, the Chinese market has grown significantly as a result of some large companies acquiring the full value chain. For example, WuXi AppTec, one of the largest CROs in the country, started as a preclinical experiment company, but grew to offer a full drug discovery service. In 2008, it acquired the American medical device giant AppTec. Another prominent Chinese CRO, VenturePharm, was born as a clinical CRO and later expanded into a preclinical research provider for big pharmaceutical companies.
Traditionally, drug makers performed their own discovery work, but CROs now perform all elements of drug and medical device discovery. Many CROs are even able to test for bio-compatibility of implants under normal physiology. This means that drug companies can outsource nearly any aspect of their discovery process.
The main goal of a Contract Research Organization is to help drug companies cut their costs and streamline their entry into the drug market. By hiring a CRO, these companies don’t have to hire their own scientists, and they don’t have to manage staff. In addition to conducting clinical research, CROs also perform post-marketing research.
