What is a contract research organization (CRO)?

A contract research organization (CRO) offers research services to the pharmaceutical, biotechnology, and medical device industries. These services are provided on a contractual basis, allowing companies in these sectors to outsource their research needs.

The role of CROs in clinical trials has evolved significantly over time. With the evolving clinical trials industry, CROs are involved in all aspects of clinical research, from study design to drug manufacturing.

The two main types of contract research organizations are…

Specialty CROs:  Focus on specific functioning areas, such as statistical analysis, patient recruitment, or data management.

Full-Service CROs:  Offering a wide range of services across all phases of clinical research, from study design to data analysis.

 

What services do CROs provide?

Contract research organizations (CROs) provide various services to biotechnology, medical device, and pharmaceutical companies. These services can cover all aspects of clinical research, from study design to data analysis.

  • Clinical Operations Services: Clinical Operation excellence is the key to each clinical trial’s success. The services range from patient recruitment, site selection, medical and clinical monitoring, and clinical project management. 
  • Biostatistics Services: Biostatistics plays a vital role in designing, analyzing, and interpreting clinical trial data. The service ranges from sample size calculation and justification to CRF, mock tables, TFL shell development, and Clinical Study Report (CSR) preparation. 
  • Data management Services: CROs can help pharmaceutical and biotechnology companies to collect, manage, and analyze clinical trial data. They can use sophisticated software – EDC (Electronic Data Capture) to ensure data is entered accurately and efficiently.
  • Regulatory Compliance Services: CROs can help pharmaceutical and biotechnology companies to comply with regulatory requirements. They can provide expertise in Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Medical Writing Services: CROs can assist pharmaceutical, medical device, and biotechnology companies in writing clinical trial reports and other regulatory documents. They can ensure these documents are clear, concise, and compliant with regulatory requirements.
  • Pharmacovigilance Services: Pharmacovigilance plays a crucial role in ensuring the safety and effectiveness of medications throughout their lifecycle. Pharmacovigilance includes ICSR preparation, safety surveillance, QPPV, and safety monitoring.

 

Key factors to consider in selecting a CRO

  • Experience in Therapeutic Areas and Project Models: The CRO should have expertise in the necessary therapeutic area of a drug or device. Moreover, the CRO should also have experience with the specific type of clinical trial that is planned. For instance, if the upcoming study is in Phase 3, the CRO should have experience conducting Phase 3 clinical trials.
  • Flexibility and Scalability: In terms of flexibility, the CRO should be able to accommodate a trial’s unique needs, meaning that they should be able to adjust to changes in timelines, protocols, or scope of work. Considering scalability, a CRO should be able to manage the increased workload without compromising quality or timelines, especially in the case of large and sophisticated clinical studies. 
  • Geographic Reach and Site Access: If your project involves multi-site studies or international trials, evaluating the CRO’s geographic reach and access to investigator sites in various regions is a must. This factor is significant if a project requires a diverse patient population or specific regulatory expertise in certain countries.
  • Costs and Budget: Evaluating the CRO’s pricing structure and ensuring it aligns with budget constraints is crucial to selecting a CRO. While considering costs are essential, they should be balanced with the CRO’s expertise and quality of service. 
  • Communication and Collaboration: Effective communication and collaboration are critical for a successful partnership. Assessing the CRO’s communication processes, responsiveness, and accessibility is a key factor. A CRO should value open and transparent communication and assigns a dedicated project manager or team for your project.

 

What are the benefits of using a CRO? 

In recent years, CROs have become increasingly important in drug development. As the cost of developing new drugs has risen, CROs have offered a way for companies to reduce costs while still maintaining high standards of quality.

Additionally, CROs have helped to simplify the development process by providing a range of services that companies may need more resources to provide in-house.

CROs also support foundations, research institutions, and universities. These organizations may need more resources to conduct clinical trials in-house, so they may partner with a CRO to get their research projects off the ground. 

Overall, CROs play an essential role in the drug development process. They can help to reduce costs, simplify development, and increase the chances of success for new medicines and drugs.