What is Site Management Organization and how it benefits your Clinical Trial?
In Clinical Trials, site refers to a space, usually a hospital or health care facility, where the practical activities are performed. It is important to follow protocols for adequate infrastructure and staff accordingly with the requirements for the trial process. Ensuring compliance with those protocols is the focus of a Site Management Organization team.
Keep reading to know more about how we can help your clinical research, saving time and money during trial, with Site Management Organization solutions.
What is Site Management Organisation?
Site Management Organization teams provide a close monitoring and coordination of activities related to a clinical research conduct. It involves ensuring that clinical trials are performed according to protocol, regulatory guidelines, and Good Clinical Practice (GCP) standards.
Clinical Trials for Medical Devices
Clinical investigations are essential studies that revolve around one or more human subjects, with the primary objective of assessing the safety and performance of a medical device. Through meticulous evaluation, these trials not only contribute to the overall understanding of medical devices but also hold the potential to alleviate the financial burden on the healthcare system by granting access to innovative treatments.
These trials are conducted at all stages of a device’s life cycle, in both the premarket and post-market phases:
Pre-market
During the pre-market phase, clinical trials serve as a crucial means of assessment before a device is made available to the general public. By subjecting the device to rigorous testing and analysis, researchers can ascertain its safety and efficacy, ensuring that it meets the required standards and regulations.
Post-market
The post-market phase of a device’s life cycle presents an opportunity to monitor its performance in real-world settings and gather additional data. Post-market clinical Follow-Up help identify any potential issues or adverse effects that may have gone unnoticed during the initial stages of development.
By closely monitoring the device’s performance and soliciting feedback from patients and healthcare professionals, researchers can make informed decisions regarding its continued use and potential modifications.
The role of SMO in clinical research
The management begins with the selection of appropriate sites for conducting the study. Factors such as site infrastructure, previous experience, patient population, and regulatory compliance are considered during selection.
Once a site is selected, the initiation process begins. This involves obtaining regulatory approvals, training site staff on the protocol and study procedures, setting up equipment, and ensuring that necessary documentation is in place.
Monitoring the outgoing trial is also responsibility of the SMO team. It involves regular visits to the site to make sure that the trial is being conducted as the protocol and GCP guidelines stipule. Source documents, collected data, participant eligibility and safety, are also validated.
At the end of a clinical trial, site closeout activities take place. This involves finalizing data collection, ensuring all required documentation is complete, returning study supplies, and conducting final site visits. Site closeout activities also include archiving study-related documents for future reference.
Site Management is designed to assist in the reduction of trial time spending and cost, leading to more efficient and accurate results. Other activities performed by a SMO team, include:
- Documentation preparing
- Managing patient recruitment
- Managing and fulfilling staff requirements and recruitment.
- Identifying and/or managing investigators and sub-investigators.
- Preparing Institutional Review Boards (IRB) submissions.
The benefits of working with a site management organization
Working with a Site Management Organization team can offer many benefits to all parts involved in a clinical trial, including:
Accelerated patient recruitment for their extensive networks of qualified patient pools.
Enhanced data management by mitigating potential delays.
Increased research team focus on the analysis of meaningful information
Reduced study timelines and costs
SMOs help clinical research teams leverage their expertise, resources, and specialized capabilities to optimize trial execution. The benefits range from improved patient recruitment and data management to heightened focus for research teams and greater cost and time efficiencies.
Eclevar – Tailored solutions for your Site Management Organization needs
Eclevar has more than 20 years of experience in providing modern solutions for the medical industry. Our expert team is ready to assist you in all steps of your clinical trial, working alongside your professionals to understand your needs.
Throughout the entire life of your medical device, count on Eclevar to help your research. Contact us to know more about our Site Management Organization services and how we can work together.
