A contract research organization is a contract research organization. This is a type of company that offers its services in the field of clinical trial management primarily to manufacturers of pharmaceutical, biotechnological and medical devices.
The management of a clinical trial is more complex than it seems, because many actors intervene in it (manufacturers, sponsors, ethics committees, competent authorities, centers, foundations, researchers, legal departments, participants…).
In addition, it is necessary to work according to the rules of Good Clinical Practice and Harmonization Guidelines (GCP-ICH Guidelines), which ensure the quality of the study. The ability to rely on the CRO as a trusted partner to lead the study is essential, and in this case the CRO acts as a bridge between the sponsor, the service provider and the rest of the study participants. clinical evaluation.
Services Offered By Contract Research Organization
CROs are traditionally in charge of initiating and monitoring clinical trials, but we are increasingly seeing companies offering all the services associate with conducting a clinical trial, which consideres “full service CROs”.
The services that a CRO can offer are divide according to the phase in which the study is:
The start-up includes the development and revision of evaluation protocols, adaptation of the necessary documentation to the applicable legislation, obtaining the necessary approvals from clinical research ethics committees and regulatory authorities, design and preparation of case report forms, determination of the sample, selection of the best researchers and research centers, and final contract negotiations.
After obtaining approval and starting the study, the CRO offers its monitoring services, which consists in checking compliance with the protocol and procedures established for the development of the study. Similarly, pharmacovigilance services include detection and action in case of occurrence of any adverse event.
Data management, report generation, and documentation review and retention are the final steps to ensure the success of any clinical trial.
During the study, the work is carried out in accordance with good clinical practice (GCP), which ensures the quality of the study.
Types Of Contract Research Organization
There are different criteria for classifying CROs:
If we take into account the level of specialization of the company, we find firms specialized in a certain type of study (clinical studies, research with medical devices or observational studies) as well as CROs specialized in a therapeutic area such as oncology or ophthalmology.
With regard to the geographical area in which they operate, we can classify CROs as local or global. Global companies tend to be large companies with headquarters around the world, their coverage is greater, but they are usually less flexible than local companies, whose knowledge of the specifics of the country is greater, but their coverage is usually not as extensive.
How To Choose A Good Contract Research Organization
Choosing a good CRO is very important, the success of the study will depend on its management and will help the trial run as smoothly as possible.
Some of the questions to ask when choosing it are:
- If you are looking for a CRO that will also advise you on the selection of centers, the number of follow-ups and perhaps even the required sample size. In the latter case, it is essential to find an experienced CRO.
- If the work method adapts to the client’s work method
- If the rates you propose are reasonable and provide a clear and itemized budget
- If it is a company committed to study
CROs are an essential part of clinical trials, offering a wide range of trial execution services that facilitate the sponsor’s work.
There are many types of CROs, so it is essential that we know what to expect from them before we start working together, as they will be a key partner in the success of the study.
Contract Research Organizations (CROs) are essential to the pharmaceutical, biotech and medical industries, supporting their efforts to test, improve and bring to market their latest drugs and devices. In 2021, the global CRO market was valued at USD 50 billion and is expected to reach an impressive USD 88 billion by 2028, with a CAGR of 8.5% from 2021 to 2028.
Growth is driven by a sharp increase in research and development spending and activity and a significant increase in the number of clinical trials with the need for new innovations. This is due to patent expirations, the rise of generics, and technological innovations such as mHealth and the impact of big data on product development, all leading to more outsourcing of CRO work.
In early 2020, when the Covid-19 pandemic first hit, it force the suspension of clinical trials as priorities shifted. However, once the market take stock, clinical research operations began to stabilize again and new avenues for growth were discovered, either through mergers and acquisitions (M&A) or becoming a more specific entity.
M&A is progressively changing the market, and some of the largest contract research organizations have been strengthened through mergers or acquisitions by other companies. In the last few years, there have been significant changes in the market:
- Clintec is absorbed by IQVIA
- PRA buys ICON
- Thermo Fisher Scientific acquires PPD
- EQT Private Equity and Goldman Sachs Asset Management buy out Parexel
In early 2022, it was also announced that CATO SMS and Pharm-Olam would merge to strengthen their position as a global leader in biopharmaceutical services. The ripple effect of these M&A activities is being felt across the wider research industry with the need for more and more outsourcing, creating a boom in Functional Service Provider (FSP) programs in larger organisations.
Also read:- What Does Ophthalmology CRO Mean?
With continued expansion, consolidation and innovation throughout the CRO industry, 2022 will be another year of change. The top ten CROs to watch in 2022 are list below, in no particular order, but include both industry leaders by market share and revenue, as well as up-and-coming companies that continue to grow their presence through strategic partnerships and innovative service offers:
Pharmaceutical Product Development (PPD) is a leading global CRO employing over 30,000 people worldwide. They are consider a premium contract research organization provider for many pharmaceutical and biotech companies and have receive a number of prestigious industry awards in 2021 including Clinical Research Company of the Year, Best Vaccine CRO of the Year and the Eagle Award from the Society for Clinical Research.
Acquisition of Evidera
Following the acquisition of Evidera in 2016, PPD has established itself as a leader in real-world research. The company leveraged Evidera’s experience with real-world evidence to provide life sciences companies with an increasingly important element of the clinical development process and help PPD remain competitive. Since then, PPD has acquired Synexus (now Accelerated Enrollment Solutions), a patient recruitment company, and Bioclinica, a clinical research company. Evidera also further strengthened its capabilities with the acquisition of Medimix, a global technology company providing real-world insights.
In 2021, PPD officially acquired ThermoFisher and became part of ThermoFisher’s Laboratory Products and Services segment. This means that PPD still functions as a contract research organization with traditional CRO services as well as their accelerated solutions. Together, PPD and ThermoFisher are able to further leverage their capabilities to bring life-changing therapies to market and ready for a very promising future with an establish drug development platform, patient enrollment expertise and robust laboratory services.
KCR is a boutique international full-service contract research organization that operates in three main service areas: trial execution, consulting and placement. Over the last 8 years, KCR has been expanding across Europe and since establishing its headquarters in Boston in 2017, the company has further increased its presence in the US. Their growing impact on the industry is pride in the human approach and the belief that there is an individual behind every number. KCR’s services are closely related to patient data and patient recruitment and it will be interesting to see how they continue to rapidly develop in this space.
In an interview with Oursourcing Pharma in 2021, CEO Mike Jagielski said, “KCR aims to continue to be the preferred clinical development partner for global biotech companies while pushing the boundaries in innovation and adaptation of direct patient engagement technologies and development strategies. At the same time, our mission is to remain a private company – to grow organically to ensure safe and long-term development.”
A leading contract research organization, ICON, operating in 46 locations worldwide, offers a full range of consulting, clinical development and commercialization services.
Also read:- What is the role of CROs in the industry?
In 2016, ICON partnered with Genomics England on the UK’s 100,000 Genomes Project and IBM Watson to support oncology research to further expand clinical research services and jobs in the genomic science and oncology sectors. ICON has completed a number of acquisitions, including: Symphony Clinical Research, MediNova, MolecularMD and MedPass International and PRA.
Also in 2021, ICON generated an impressive $5.5 billion in revenue after helping to develop 30 customer drug and device approvals in the year, including breakthrough vaccines and Covid therapies. It is on track to continue to achieve exceptional growth as it approaches the transformation into the largest and most comprehensive healthcare news organization in the world, so it is exciting to watch.
In 2016, Quintiles and IMS Health merged to become IQVIA. As the world’s largest CRO, IQVIA operates in more than 100 countries worldwide, bringing together advances in data science, technology and humanities expertise to offer its clients comprehensive clinical and commercial services. After a series of other acquisitions of smaller niche companies, the company continues to strengthen and remains truly at the forefront of the contract research organization world.
With full-year 2021 revenue of $13,874 million, the company grew 22.1% on a reported basis and 21.1% at constant currencies compared to 2020. IQVIA had a record year of net new business in R&D, strong double-digit revenue growth for their technology and analytics solutions division. In a press release, IQVIA’s Chairman and CEO, Ari Bousbib, confirmed that demand from end markets remains favorable and they expect to continue to experience high demand for their differentiated offerings, meaning the company is on track to achieve the next phase of growth and achieving the ambitious 2025 target.
Founded in 1982, Parexel specializes in conducting clinical trials on behalf of its pharmaceutical partners to expedite and streamline the drug approval process. The company offers a wide range of services that cover almost every type of clinical trial service and assist sponsors in conducting successful clinical trials.
In July 2021, it was announce that Parexel would buy EQT Private Equity and Goldman Sachs for $8.4 billion. Parexel CEO Jamie Macdonald said: “Parexel has continued its strong growth trajectory by focusing on patients and accelerating new therapies to patients in need around the world. With the market for outsourced clinical research services expected to grow at a conservative CAGR of 8-9%, our focus remains on Parexel’s progress and innovation to meet the needs of our customers in the evolving clinical development landscape. EQT and Goldman Sachs support this vision and want to invest in Parexel and our people to take advantage of this exciting market opportunity and make a difference for patients.”
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