Please contact us at info@sofpromed.com if you need a CRO to manage a clinical trial
Clinical research organizations (CROs) have become key players in the pharmaceutical, biotech, and medical device industries.
In this article you will learn about:
They provide a wide range of services to sponsors, helping them manage and streamline the complex process of conducting clinical trials.
In this guide, we will explore the definition of a CRO, the services they offer, the benefits of outsourcing to a CRO, and how to choose the right one for your clinical study.
Introduction to CROs
A CRO, or Clinical Research Organization, is an outsourced company that specializes in managing and overseeing clinical trials on behalf of sponsors.
They act as a bridge between the sponsor and other stakeholders involved in the trial, ensuring its proper development and adherence to regulatory standards.
In the past, CROs focused on specific services such as data management, regulatory support, or onsite monitoring.
However, modern CROs have transformed into full-service providers, offering comprehensive clinical trial management support.
Services Offered by CROs
CROs provide a range of services throughout the lifecycle of a clinical trial.
Let’s explore some of the key services offered by CROs:
Clinical Trial Management Services
Clinical trial management services encompass various activities involved in the planning, design, and execution of a clinical study.
CROs assist sponsors in developing protocols, adapting documentation to regulatory requirements, obtaining necessary approvals, designing case report forms, selecting research sites, and negotiating contracts.
Site Feasibility
CROs are key partners for site feasibility, identifying suitable research sites for the clinical trial.
This process involves assessing the expertise and availability of potential sites, ensuring they meet the trial’s specific requirements.
CROs conduct thorough research, reaching out to sites, and evaluating their interest and resource availability.
Project Management
Project management is a vital service provided by CROs.
They oversee the execution of the clinical trial, tracking project metrics, timelines, study budgets, and managing third-party vendors.
CROs act as trusted partners, ensuring project execution aligns with the sponsor’s objectives and making necessary adjustments when needed.
Onsite Monitoring Services
Onsite monitoring services involve regular site visits by Clinical Research Associates (CRAs) or trial monitors.
CRAs serve as the main point of contact for research sites, maintaining frequent communication to review project timelines, discuss study updates, address adverse events, and assist with study supply needs.
They ensure protocol compliance and review data for discrepancies.
Medical Monitoring Services
CROs may offer medical monitoring services to ensure patient safety during clinical trials.
Medical monitors review adverse events, concomitant medications, safety data, and provide support for safety-related questions.
Their expertise contributes to maintaining the highest standards of participant safety throughout the trial.
Biometrics Services
Biometrics services provided by CROs involve managing and analyzing the data collected during the clinical study.
This includes designing data collection forms, programming software for data capture, ensuring accurate data entry, conducting statistical programming and analysis, and preparing the final clinical study report for the sponsor.
Quality Assurance
CROs are in charge of professional quality assurance in clinical trials.
They provide quality analysis, regulatory planning, and training.
CROs adopt standardized operating procedures (SOPs) and assist organizations in implementing effective quality control measures.
They help sponsors comply with regulatory requirements, avoid legal pitfalls, and maintain the highest standards of research integrity.
Types of CROs
CROs can be categorized based on specialization and geographical coverage.
Specialization can include focusing on specific types of studies (clinical trials, research with medical devices, or observational studies) or specializing in a therapeutic area such as oncology or ophthalmology.
Geographically, CROs can be classified as local or global, with global companies having broader coverage but potentially less flexibility than local companies.
How to Choose a CRO
Choosing the right CRO is essential for the success of your clinical trial.
When selecting a CRO, consider their experience, types of projects completed, client history, niche services, and overall track record.
Evaluate whether the CRO can provide guidance on site selection, monitoring requirements, and sample size determination.
Ensure that their way of working aligns with your organization’s needs, and carefully review their proposed rates and budget.
Look for a CRO that demonstrates a commitment to the study and has a spotless track record in quality assurance and control.
Conclusion
Clinical research organizations play a vital role in managing and overseeing clinical trials.
Their comprehensive services span from study design and site feasibility to project management, monitoring, biometrics, and quality assurance.
By outsourcing to a CRO, sponsors can streamline their research processes, access specialized expertise, ensure compliance with regulatory requirements, and improve the overall efficiency and quality of their clinical trials.
When choosing a CRO, it is crucial to consider their experience, track record, and ability to meet your specific needs.
Partnering with the right CRO can significantly contribute to the success of your clinical study.
Please contact us at info@sofpromed.com if you need a CRO to manage a clinical trial
