WHAT IS A CRO?
What is a Contract Research Organization?
A Contract Research Organization (CRO), sometimes known as a Clinical Research Organization, is an organization contracted by another company to take the lead in managing that company’s trials and complex medical testing responsibilities. Contract Research Organizations reduce the cost of research and development to help businesses and institutions meet the needs of the evolving medical device and pharma industry.
Topics covered below:
- What is Clinical Outsourcing?
- What Does a Contract Research Organization Do?
- Benefits of Outsourcing to a CRO
- Working With a CRO
- Contract Research and Manufacturing Services (CRAMS)
What Is Clinical Outsourcing?
Clinical outsourcing occurs when a company hires another company made up of researchers and experts to conduct comprehensive and complex medical research so that the hiring company does not have to staff experts in-house, or maintain the required infrastructure and office space. This enables the hiring company to receive expert medical testing while also saving both time and money.
To reduce the cost of research and development, drug companies are increasingly outsourcing their medical testing responsibilities to alleviate the growing and ongoing cost of maintaining medical facilities and full-time staff year-round.
What Does A Contract Research Organization Do?
Contract Research Organizations (CROs) conduct clinical trials and research support services for biotechnology, medical device, and pharmaceutical industries, as well as universities, government organizations, and foundations.
CROs are able to provide a wide range of clinical research services to medical sponsors, including, but not limited to:
- Project Management
- Procedures and Logistics
- Resource Allocation Management
- Data Management
- Database Design
- Data Entry and Validation
- Database Maintenance and Archival
- Security Procedures
- Clinical Study Management
- Site Recruitment
- Patient Recruitment
- Study Monitoring
- Site Management
- Research Compliance
- Audits/FDA inspection support
- Research Education
- Clinical SOP Development
- GCP Seminars
- Medicine and Disease Coding
- Validation Programming
- Product Development Planning
- Market Assessments
- Market Research
- Strategic Planning Consultation
- Medical Product Registration
- Product Commercialization
- Market Research
- Product Launch
- Product Marketing
- Product Sales
- Safety and Efficacy Summaries
- Quality Reporting
- CRF review
- Statistical Methodology Consultation
- Statistical Analysis Plan Development
- Statistical Analysis Reports
- Final Study Reports
- Medical Writing
- Clinical Study Protocol Documents
- “Instructions for Use”
- PowerPoint Presentations
- White Papers
Benefits of Outsourcing to a CRO
Outsourcing to a Contract Research Organization can bring multiple benefits to clinical professionals and institutions.
When choosing to outsource clinical work, consider:
- Time Savings
- Cost Savings
- Advanced Technological Needs
- Evolving and Complex Regulatory Requirements
Outsourcing to a CRO saves critical time in the trial and development phase. Working with a CRO to conduct a trial often significantly reduces the time it takes compared to completing the trial in-house. CROs are already set up with all of the necessary tools and resources needed as well as a team of in-house experts who are experienced in all areas of clinical testing, development, and compliance.
There are significant cost savings in hiring a CRO. A faster trial process alone offers medical institutions a reduction in costs. There are also financial savings in each long-term purchase an entity would incur in order to run sufficient research trials. Full-time staff and medical facilities are costly year-round, especially when they are not needed during all parts of the year.
Advanced Technological Needs
Working with a CRO gives hiring companies access to the most advanced technology and systems for data management, product development, research analysis, and other clinical research services. Clinical research is a rapidly changing industry. It is essential that software and hardware IT capabilities, as well as Internet-based applications, are the best in the industry to facilitate the acceleration of clinical trials while maintaining comprehensive quality control.
Evolving and Complex Regulatory Requirements
The FDA and other relevant regulatory authorities require intricate and accurate data for approvals. CROs work within clinical compliance on a daily basis, which gives them intricate knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits or Good Laboratory Practice (GLP) audits. CROs work with hiring companies to optimize audit results through careful review of any previous issues, close inspection of infrastructure, and adherence to current protocols.
Working with a CRO
Selecting a CRO
There is a wide variety in CROs. Some are large, publicly owned companies with global coverage and a range of comprehensive services, while other CROs are small, privately owned companies that specialize in a specific niche area. Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to the next. When selecting a CRO, take into account the company’s previous experience, including the types of projects completed, the clients they have worked with, any niche services they provide, as well as their overall track record in the industry.
Before you decide, read our guide on how to efficiently and effectively evaluate Clinical Research Companies and download our CRO Evaluation Checklist.
A business, organization, or institution may transfer any or all of their clinical trials and research responsibilities over to a Contract Research Organization, but the responsibility remains with the original company hiring the CRO. The quality and integrity of the clinical research data continue to reside with the entity sponsoring the work. CROs should be backed by a spotless track record of quality assurance and quality control.
Get It In Writing
When hiring a CRO, always ensure each delegated task is outlined in writing and signed by both parties. All agreements should be thoroughly documented by all of the involved parties to avoid any costly misunderstandings or complications. It should be very clear which organization is responsible for each aspect of the medical research, development, or other clinical services. Any services or components that are not specified in the agreement will remain the responsibility of the hiring entity.
What Is Contract Research And Manufacturing Services?
Contract Research and Manufacturing Services (CRAMS) is a broader clinical outsourcing term that includes CROs as well as CMOs, Contract Manufacturing Organizations.
Contract Manufacturing Organizations (CMOs) are similar to CROs, in that they are also hired by another pharmaceutical company on a contract basis. The purview of a CMO is in the development of a drug through to its manufacturing.
They all make up a rapidly expanding segment of the biotechnological and pharmaceutical industry. Outsourcing specialized clinical research and manufacturing work continues to develop as organizations aim to meet the needs of an evolving industry.
Promedica Intl. (PMI) delivers the quality and consistent results of a large Clinical Research Organization with the efficiencies and responsiveness of a small CRO. PMI can support your needs with a range of specialized services, including Project Management, Product Development Planning, Clinical Study Management, Product Commercialization, Medical Writing, Biostatistics, Data Management, and Research Compliance & Education.
PMI’s quality control procedures for statistical
output involve a combination of independent programming
and internal review to verify accuracy and completeness
of tables, figures, and listings.