What is a Contract Research Organization: CRO?

Pharmacist Paula Andrea Pirson
May 30, 2022
4 min read

A “CRO” is a Contract Research Organization that provides outsourced consulting services to the biopharmaceutical industry, through an agreement established between both parties. CROs also support foundations, research institutions, and universities, as well as government organizations (such as the NIH, EMA, etc.). These companies range from large international organizations with more than 1,000 full-service employees to small groups focused on specialized niches.

Why do pharmaceutical companies hire a CRO?

the profitability of the industry to be significantly increased. Globally and for more than two decades, a large number of CROs have provided support for the Clinical Studies and Trials of drugs and/or medical devices for human and/or animal use. Contract organizations make specialized know-how available to their clients to coordinate all stages of a new drug or device; from its conception to the marketing approval by the local health authority (FDA/EMA/ANMAT/ANVISA, etc.). In this way there is no need for the sponsor of the product to have a staff in charge of these services.

The phases from discovery to approval are detailed in Figure 1. Phases of clinical pharmacology studies

Somehow they have become a very important ally for the Clinical Research industry and their great demand is due to the fact that they comply with the highest standards of scientific quality and medical ethics. Currently, CROs make up about half of the research workforce involved in drug and medical product development.

What are the benefits of hiring a CRO?

The advantages of having this type of service are not simply reduced to one or two aspects, but, on the contrary, are multiple. But without a doubt, the greatest benefit of hiring regulatory affairs consulting is cost-effective and lies in optimizing the performance and value of the client portfolio. CROs walk their clients through the entire process and inform decision-making throughout its development, ensuring they have the strongest possible foundation for proving value and effectiveness.

Regulatory Outsourcing services include:

• Shipping management

• Compilation, publication and submission of regulatory files

• Lifecycle Research and Maintenance Requests

• Marketing authorization documents and product maintenance

• Post-approval lifecycle maintenance

• Content creation and document services.

Why use Regulatory Affairs Outsourcing?

CRO regulatory outsourcing services adopt an operating model specifically designed to offer a high-quality, cost-effective solution for maintaining the lifecycle of established products.Most CROs uniquely combine the right technology systems for approval of their registrations, operational resources, and global and local regulatory intelligence to deliver these services. The result is a scalable and flexible outsourcing model that generates significant predictable savings year after year and addresses regulatory complexities, increased workloads and limited budgets facing the industry. In the last five years, pharmaceutical companies have been evolving towards the Full-Service model due to the satisfactory cost/benefit ratio they have experienced when implementing this business policy. According to specialized surveys over the last five years, it is estimated that biopharmaceutical companies can spend up to two-thirds of their budgets on regulatory resources to keep their products approved and marketed. Consequently, outsourcing has become a very attractive and key strategy in the healthcare industry, allowing clients to focus their expertise on core competencies and innovation while moving to variable cost models through a smaller workforce. Considering the data from the regulatory agencies, it is possible to mention the therapeutic areas with the highest incidence in the international market in the Research and Development (R&D) of drugs, where Oncology, Cardiology, Central Nervous System, Metabolism, Infectiology, System Respiratory, Gastroenterology, Obstetrics and Gynecology. By applying multi-disciplinary expertise both internally and externally where it is needed most, regulatory outsourcing can greatly reduce costs, improve processes and speed time-to-market approvals.

Regulatory aspects

Specifically, those CROs that provide Clinical Trial services are governed by the International Conference on the Harmonization of technical requirements for the registration of pharmaceutical products for human use (ICH-GCP) (E6 1.20). In this sense, according to the ICH-GCP (E6) the considerations on the functions and obligations of the sponsors of the Clinical Trials and the contracted organizations are established in detail. Clinical Research must be approached with absolute transparency, guaranteeing the maximum protection of the participants. Therefore, this activity must be carried out according to the guidelines proposed by the Declaration of Helsinki (in its latest version), approved by the World Medical Association, the Document of the Americas and related local legislation. This regulatory framework is intended to prevent any type of abuse and deviation from the established standards. The most globally recognized CROs that occupy the top positions in the ranking, are located with central offices in the most developed countries, with numerous regional subsidiaries around the world and recruit specialists of all nationalities who internally articulate with the work teams to achieve the success of assigned projects. They have thus contributed to the development of more than 95% of the 200 best-selling pharmaceutical products in the world

Source

https://drive.google.com/drive/u/0/folders/1Rs5Qqih47sbJj4WAC0aaoxHXTLjECUOH

SAFYBI Magazine, Vol N°58, Edition N°157, Section: Research and Development, p.46, article. Published in March, 2018 www.safybi.org

References

a) The CRO Market”, Association of Clinical Research Organizations.

b) Bio-Definitions, Biotech Media.

c) Clinical Outsourcing Market To See Continued Growth Through 2020. www.clinicalleader.com

d) Global Growth Story Remains Strong For CROs in 2008, Beyond”, Center Watch Monthly March 2008.

e) KMR Group, Inc.

f) PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2004/2005.

g) PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2003/2004. p26

h) ACRO Association of Clinical Research Organizations