India has many hospitals, well-qualified and experienced doctors, patients with chronic and infectious diseases, a low-cost market, and easy patient recruitment, leading India to become a hub for conducting clinical trials and Site Management organisations. In this fast-paced world where new diseases and infections are developing, which require medical treatment very quickly and accurately. Initial testing is essential in making these medical treatments more accurate and successful.
It is well known that all medical treatments must pass through rigorous testing before being released to the public. This initial testing is known as a clinical trial. Trial results make a decision-making difference between a new treatment passing regulatory approval and entering the market or not.
What is a “Site Management Organization” (SMO)?
As the name “Site Management Organisation” itself states, it is an organization that provides clinical trial management services to global pharmaceutical, biotech, or medical companies. Site management organizations are new entrants into the field of Clinical Research, aiming at the economic conduct of Clinical Trials. The site management organisation provides highly qualified and experienced Study Coordinators (SCs) and Site Management Associates (SMAs) to support both principal investigators and sponsors.
What are Clinical Trials?
Clinical trials are research studies performed by medical professionals and researchers on people that are aimed at evaluating a medical, surgical, or behavioural intervention. This is the primary way for researchers to find out if a new treatment, like a new drug or diet, or medical device is safe and effective in people. Clinical trials are usually conducted to determine if a new treatment is more effective and/or has fewer harmful side effects than standard treatments.
A clinical trial is a very complex and crucial process that requires effective and efficient management. To run and manage clinical trials effectively and efficiently, the site management organisation (SMO) comes into play.
Responsibilities of Site Management Organisation (SMO)
The scope of a Site Management Organisation’s responsibility is limited to the site. Some of the responsibilities include as below:
- Project Feasibility
- Contract
- Investigator Selection
- Submission of Documents (for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval), Submission to the Ethics Committee is often done by the sponsor or by Contract Research Organization (CRO), i.e. not by Site Management Organization (SMO)
- Patient Monitoring
- Patient Counseling
- Patient Follow-up
- Informed Consent Form (ICF) Translation into the vernacular language
- Site initiation and trial close-out operations
- Trial-related documents archival and maintenance
- Reporting serious adverse events to the Sponsor or Contract Research Organization CRO and the Independent Ethics Committee (IRB/IEC)
- Ensuring protocol compliance
- Advising & alerting investigators of potential protocol violations
- Advising & alerting investigators of potential ICH-GCP violations
Benefits of Site Management Organisation (SMO)
Traditionally, clinical trials were conducted in outpatient departments and by specialists at large municipal and university hospitals as part of their day-to-day duties. Clinical trials are becoming increasingly expensive due to challenges posed by different regulatory systems and cultures. It is vital to understand local requirements in order to avoid delays. To avoid these crucial issues and high-cost site management, organizations play a vital role.
Site management organizations have a lot of benefits apart from efficient management, which are as below:
1. Faster patient recruitments – SMOs are more effective and efficient in attracting and keeping patients by making good use of networks of qualified patient pools and quick follow-up.
2. Improved data management – With the evolving technological infrastructure and data handling processes in place to manage both regulatory and clinical data, SMOs limit delays that can sometimes happen with study and regulatory data addressing inefficiencies.
3. Focussed Research: A common mistake Clinical Research teams make is that teams focus and spend more time cleaning data than interpreting data. As menial labour is delegated by SMOs, research teams have more time to study and focus on important data
4. Shorter study timeframe and cost-effectiveness: SMOs offer end-to-end clinical trial-related services, from setup to monitoring, compliance activities, and closeout, to speed up clinical research timeframes and stay within budgets. This results in shorter study timeframes and cheaper expenses.
5. Risk Mitigation: SMOs Identify and address potential challenges and risks, they minimize the impact on trial outcomes and timelines. They also Implement proactive risk management strategies to make sure of a successful clinical trial journey.
6. Collaborative Advantage: SMOs provide a collaborative platform for stakeholders to share insights, leading to improved decision-making throughout the trial. They keep a close working relationship between trial sites and sponsors. It helps to facilitate effective communication.
Why is Site Management Organisation (SMO) important?
Medical research is the most important way to improve medicine. To efficiently conduct medical research requires a lot of management, as there are many people involved in clinical trials. For successful clinical trials, Site Management Organisation (SMO) plays an essential role. Site Management Organization (SMO) is the bridge between sponsors and sites that conduct clinical trials.
Site Management Organisations work as a centralized administration, which means Site Management Organisations (SMO) can manage a few sites working under one unified clinical research standard.
Pharmaceutical industries are facing extreme pressure to reduce drug development cycle times. Clinical trials contribute a significant proportion of drug development time. During clinical trials, the recruitment of patients consumes a lot of time which is a key factor in the trial delay. To address this need, Site Management Organisations (SMO) have evolved into organisations that conduct clinical trials using specialist physicians and nurses.
Site management organisations (SMOs) are very effective and efficient at attracting and keeping patients. With technology, infrastructure, and data handling mechanisms, SMOs can decrease the timeframe of compliance with government regulations.
A well-managed clinical site ensures the smooth execution of clinical trials and the best possible results. By adhering to the study protocol and relevant regulatory guidelines, sites can recruit and retain subjects effectively.
A successful collaboration with the sites depends on proper site management throughout all phases of the trial. Collaboration increases efficiency, improves communication, complies with regulations, and ensures data quality.
Conclusion
As with any industry, there is room for improvement regarding collaboration between sponsors and sites, but SMOs have proven time and again to be valuable partners who can smoothly deliver superior trials by providing support at every stage of development.
In the end, we can conclude that outsourcing a clinical trial to a site management organization (SMO) can be a real help to the global pharmaceutical industry since SMOs will minimize their workload effectively and efficiently. The expertise of site management organizations in managing clinical trials ensures a smooth study, from regulatory compliance to data collection and analysis.
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FAQs about Site Management Organisation
1. What is the difference between an SMO and a CRO?
SMOs and Cros operate in the clinical research domain, SMOs act as the bridge between Sponsors and clinical trial sites, whereas CROs manage entire clinical trials.
2. What does SMO stand for in pharma?
In the pharmaceutical industry, SMO stands for Site Management Organization, serving an important role in helping clinical trial sites and sponsors
3. What is an SMO in clinical research?
In the Clinical Research domain, an SMO functions as a service provider delivering clinical trial management services to biotech, medical and pharmaceutical companies.SMOs assist sponsors in meeting regulatory requirements effectively.
