India has many hospitals, well-qualified and experienced doctors, patients with chronic and infectious diseases, a low-cost market, and easy patient recruitment, which has led India to become a hub for conducting clinical trials and Site Management Organisation. In this fast-paced world where new diseases and infections are developing each month or year, which require medical treatment very quickly and accurately.
Initial testing is essential to making these medical treatments more accurate and successful. All medical treatments pass through rigorous testing before being released to the public, and this initial testing is known as a clinical trial.
What are Clinical Trials?
Clinical trials are research studies performed by medical professionals and researchers in people that are aimed at evaluating a medical, surgical, or behavioral 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 organization (SMO) comes into play.
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.
Site Management Organisation (SMO) Services
The scope of a Site Management Organisation’s responsibility is limited to the site. Some (but not all) 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)
- 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:
- Faster patient recruitment
- Low initial investment
- Reduction of time
- Improved data management
- Focussed research
- Shorter study timeframe & cost-effective
- Standardize process of clinical trials conduct
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 Organization (SMO) plays an essential role. Site Management Organization (SMO) is the bridge between sponsors and sites that conduct clinical trials.
Site management organizations work as a centralized administration, which means Site Management Organization (SMO) could 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 Organizations (SMO) have evolved into organizations that conduct clinical trials using specialist physicians and nurses.
Site management organizations (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
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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