Clinical trials are a make-or-break stage in the development of a new treatment. The results of this research can be the difference between a new therapy that passes regulatory approval and gains widespread usage and one that does not.
It’s hard to overstate how operationally complex this stage of the process can be. Among other challenges, clinical research teams have to navigate issues around the enrollment of qualified patients, meeting strict regulatory guidelines, and handling massive amounts of data — all while moving quickly to meet deadlines.
This complexity is why 80% of all clinical trials finish at least one to six months behind schedule, and only 10% of trials finish on time.
However, many clinical research teams have successfully worked with specialized providers who can tackle the operational overhead, allowing the research team to focus on their trials. One such provider is a site management organization (SMO).
What is a site management organization (SMO)?
A site management organization is a provider that delivers operational and administrative support services to the clinical investigator at a research site. This includes everything from handling regulatory and compliance activities to managing patient recruitment and data collection. SMOs can also provide support with study start-up, monitoring, and closeout.
SMOs work with pharmaceutical companies, biotechnology companies, clinical research sites, contract research organizations (CROs), and others to enable those organizations to deliver their research in a time-efficient manner.
Benefits of working with a SMO
Working with a site management organization can offer many benefits to clinical research teams, including:
- Faster patient recruitment – SMOs leverage networks of qualified patient pools and faster follow-up to recruit and retain patients more efficiently than in-house teams.
- Improved data management – With the technological infrastructure and data handling processes in place to manage both clinical and regulatory data, SMOs limit delays that can sometimes crop up with study and regulatory data addressing inefficiencies.
- Better focus for research teams – A common pitfall that clinical research teams can face is spending more time cleaning data than analyzing data. With the grunt work outsourced to SMOs, research teams have more time to analyze meaningful data.
- Shorter study timelines and lower costs – SMOs provide end-to-end clinical trial-related services, from setup to monitoring, compliance activities, and closeout, to shorten clinical research timelines and stick to budgets.
Clinical studies can be fraught with challenges, but like CROs, SMOs offer the capability to outsource the most challenging work to service providers who specialize in operational complexity. They can rein in excess costs and allow research teams to finish on time.