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When it comes to conducting medical research, there is a multitude of responsibilities sponsor companies face in ensuring studies are conducted smoothly and on time. Contract research organizations (CROs) are entities that help manage the complex duties that these pharmaceutical, biotech, medical device, and government and academic agencies come into when developing new therapies from study startup through close-out. For many sponsor companies, it can exhaust far more time, resources, and money to take on these services in-house, so it is highly beneficial to employ a CRO.
However, the role of a CRO is more complex and far-reaching than this definition suggests. Most clinical trial CROs today are full-service and manage the majority if not all services required to conduct a clinical study. While sponsors fund and are ultimately responsible for the clinical trial process, they rely heavily on CROs to provide their offerings and expertise in areas such as protocol development, site management, recruitment, data management, regulatory compliance, pharmacovigilance, commercialization, and more.
A Clinical Research Organization, or CRO, provides clinical trials and research support services to a variety of entities, including biotechnology, medical device, and pharmaceutical industries, as well as universities, government organizations, and foundations.
CROs have the capacity to offer a broad range of clinical research services to medical sponsors. These services can include, but are not limited to, project management, data management, clinical study management, research compliance, research education, medicine and disease coding, validation programming, product development planning, product commercialization, safety and efficacy summaries, quality reporting, biostatistics, and medical writing.
The services provided by a CRO can span the entire timeline of a study. For example, during the study start-up, a CRO might be involved in the development and revision of protocols, adaptation of necessary documentation, obtaining approvals from clinical research ethics committees and regulatory authorities, design and preparation of case report forms, determination of the sample, selection of researchers and research centers, and final negotiation of contracts among all parties.
Once regulatory approval is obtained and the trial begins, the CRO can provide monitoring services. This involves controlling compliance with the protocol and established procedures for the development of the study. Pharmacovigilance services include detection and action in case of any adverse events.
The final steps to ensure the success of any clinical study are the statistical analysis and management of the trial data, the generation of reports, and the control and storage of the documentation.
Outsourcing to a CRO brings multiple benefits to clinical professionals and institutions. The decision to outsource clinical work should take into account factors such as time savings, cost savings, advanced technological needs, and evolving and complex regulatory requirements.
Time Savings: Working with a CRO can significantly reduce the time it takes to conduct a trial compared to completing the trial in-house. CROs already have all the necessary tools, resources, and an experienced team of in-house experts.
Cost Savings: Hiring a CRO can lead to substantial cost savings. A faster trial process alone offers financial benefits to medical institutions. Additionally, the costs associated with maintaining a full-time staff and medical facilities year-round can be mitigated.
Advanced Technological Needs: Collaborating with a CRO provides access to the most advanced technology and systems for data management, product development, research analysis, and other clinical research services.
Evolving and Complex Regulatory Requirements: The intricate knowledge of regulatory requirements and audits, such as Good Clinical Practice (GCP) audits or Good Laboratory Practice (GLP) audits, is a significant advantage of working with a CRO.
Choosing a CRO: The landscape of CROs is quite diverse, ranging from large, publicly owned companies with global coverage and a comprehensive array of services to small, privately owned companies that specialize in specific niche areas. Comparing one CRO to another can be challenging as budgets and services can vary significantly.
Sponsor's Responsibility: Although a company may transfer any or all of their clinical trials and research responsibilities over to a Contract Research Organization, the responsibility still lies with the original company hiring the CRO.
Written Agreements: When engaging a CRO, it's essential to have each delegated task outlined in writing and signed by both parties. This helps avoid any misunderstandings or complications.
Contract Research and Manufacturing Services (CRAMS) is a broader term in clinical outsourcing that includes CROs as well as Contract Manufacturing Organizations (CMOs).
CROs have evolved over the years to meet the changing demands of the healthcare industry. Today, many CROs offer a full suite of services, from pre-clinical research to post-marketing surveillance, as well as various administrative activities.
Selecting the right CRO for your clinical trial is crucial. Sponsors should consider their project needs, requirements, and budget when selecting a CRO. Additionally, the qualification, experience, and quality system processes of the CRO should be evaluated.
A CRO's role in conducting clinical trials is heavily regulated. The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use has defined a set of responsibilities for a CRO. Moreover, the U.S Food and Drug Administration (FDA) has also provided regulations and guidelines that CROs must adhere to.
Clinical Research Organizations play a vital role in the healthcare industry, providing a range of essential services to pharmaceutical, biotech, medical device, academic, government, and public health organizations. Understanding what a clinical research organization is and how it operates is crucial for any entity involved in clinical research and drug development. As the healthcare landscape continues to evolve, the role and importance of CROs are expected to grow even further.
