Whether you’re looking for essential clinical trial assistance or help with site selection, you’ll almost certainly find that a clinical research organization can help. When choosing top clinical research organizations, ensure you understand what they do. Knowing their methods can make all the difference in your experience and service. Let’s explore some of the most common ways they help.
Clinical Trial Management
Organizing and executing clinical trials can be difficult, but it can be made easier with the help of a clinical trial management organization. These organizations have cutting-edge technology, IT support, and hands-on medical equipment to help study teams conduct their studies. Technology is constantly evolving, so clinical research organizations must keep up with new developments. CROs have the expertise to implement new technology while maintaining regulatory compliance.
One benefit of using a CRO is that it can significantly reduce development time. Clinical trial management services may include completing protocol creation or review, contacting clinical research sites, and more. Depending on the study phase, these services can be extensive and time-consuming.
Site feasibility is an essential step in establishing a clinical trial. It focuses on ensuring that a site can accommodate the required number of participants and the type of research being conducted. In addition, it should have the appropriate infrastructure and resources for a clinical trial. This includes access to biological samples, drug storage, and staff expertise.
While the process may involve a questionnaire, screening visits are an excellent way to identify potential problems and obstacles that may arise during the trial. Additionally, these visits can help investigators determine the feasibility of a particular study site and the appropriate recruitment strategies.
There are a variety of advantages to implementing a data-tracking solution for clinical research organizations. The first is the ability to monitor progress at specific trial levels. This includes tracking actual versus target enrollment and site monitoring. Another benefit is the ease of use. Some applications even integrate with financial systems, allowing invoicing approvals and dashboards.
The second advantage is generating statistically appropriate conclusions from collected data. This improves the quality of research results and can cut the time from drug development to marketing. Finally, proper data collection requires the collaboration of a multidisciplinary team. This includes researchers, biostatisticians, database programmers, and support staff.
Compliance with Regulatory Agencies
Clinical research organizations must follow strict guidelines to comply with government and industry regulatory agencies. This includes ensuring patient and subject information security, ensuring proper SOP compliance, and highlighting deviations from SOPs. In addition, organizations should use clinical research information management systems to facilitate compliance and audit trails. These systems also enable remote access to research documents and provide real-time digital monitoring of research activities.
The investigator should also discuss potential fraud violations with the center’s POC, DIB, and sponsor. In addition, they should obtain all relevant organizational charts, which document the hierarchy of functions and individuals involved in developing an investigational product. This documentation will allow the investigator to identify who has the authority to review data about the investigational product.
Protecting Research Participants
Protecting research participants is essential for the scientific process, as research on human subjects is essential for identifying new treatments and potential risks. The ethical practices of clinical trials must adhere to several principles, including the Belmont principle of beneficence, which calls for the maximization of benefit to research participants and the minimization of harm. In addition, clinical research organizations should ensure those study participants are adequately informed of the nature of their participation. Obtaining consent from parents and legal guardians is essential in ensuring that participants are fully informed of the risks involved in the research.
The federal government requires clinical research organizations to educate key personnel involved in PHS-funded studies of human subjects. This is done through the Belmont Report, which codifies basic ethical principles in biomedical research. In addition, there is the Declaration of Helsinki, which is an international agreement on research involving human subjects. This agreement has been updated several times throughout the years. Finally, there is the Nuremberg Code, ratified by nations following World War II following abuses in Nazi clinical trials. These standards set the international standard for ethical clinical research. In addition, the U.S. Common Rule also ratifies critical protections for clinical trial patients.