Clinical research studies do not necessarily all involve medical treatments or experimental therapies. Clinical research can include observational studies, in which people are followed over a period of time to determine health outcomes.
Clinical research may also be used to determine the usefulness or safety of a new diagnostic procedure or drug treatment. Clinical Research Courses are planned in advance and follow a defined protocol. Epidemiologic studies examine specific populations to clarify how often a disease occurs or is found in a given group (the incidence and prevalence), the individual factors that can cause or worsen disease progression, and the types of health and lifestyle decisions that people make.
Before we talk about the consolidation trend between clinical trial sites, it is important to distinguish between two business models in the clinical research industry:
1. Free-standing research sites, or dedicated research centers
These sites only perform research and do not provide ongoing clinical care (outside of the study duration). They have a dedicated facility, hire physicians as employees or contractors to serve as principal investigators, and source their patients from advertisements, their subject database, partnerships with health care providers, and community outreach. The advantages enjoyed by these free-standing clinical trial sites are focus and greater ability to control operations, but they generally require more capital and operate at higher break-even thresholds.
2. Physician affiliated clinical trial sites
These sites are co-located within physician practices and manage research on behalf of those practices. They use the physician’s facility, source patients primarily from the practice database, and share revenue with the physician. This arrangement is more subject to the whims of the practice, but is easier to scale, with lower break-even thresholds.
A site network is simply a combination of sites pursuing one or both of the above models. Some networks are exclusively free-standing; some are exclusively managed (SMO); and some combine both types under one operation. For instance, a local network might resemble a hub-and-spoke, with a large stand-alone site (the hub) that sends coordinators over to neighboring physician practices to manage operations (the spokes).
Site Management Organization (SMO)
An organization that provides clinical trial-based services to a clinical research organization, a biotechnology company, a pharmaceutical company, or even a clinical site is known as a site management organization. The site is generally a hospital or a healthcare institution having adequate staff and infrastructure to meet the requirements of the clinical protocols. The site management organization (SMO) is responsible for contracts, submission of relevant documents to the ethics committees and review boards, patient counseling, patient recruitment, site initiation and close-out operations, informed consent forms, patient follow-ups, making sure of protocol compliance, advising and alerting on various matters, archival of trial-related documents and their maintenance, regarding and taking suitable actions on multiple violations with respect to protocols, etc Therefore, one needs to enroll in clinical research courses to equip themselves to understand the working of clinical trials..
Importance of Site Management Organization Clinical Research in Present Time
Importance of Site Management Organization Clinical Research in Present Time Clinical trial and clinical research are one of the most significant aspects of the modern medical science. Today most of the countries aim to become the hottest destination for global clinical research with increase in number of hospitals, doctors and, attractive pool of patients. These clinical researches help medical practitioners to build a bright future in the medical industry.
Clinical Research In order to accomplish a successful, reliable and cost-effective global clinical research, it’s vital to attract international companies to conduct trials and research. This is the point where site management organization (SMO) for clinical research comes into play. Site management organization for clinical research is most significant way of conducting a successful trial with lower expenditure in a particular region. Below are few points that can help you to understand the importance of Site management organization for clinical research.
- Real-time insight: Better site management organization (SMO) means better execution of operational activities and easy access to necessary information. Additionally, it offers robust reporting abilities that further aids real-time insight into activities associated with the trial or research.
- Better financial management: The key purpose of site management organization for clinical research or trial is to reduce the cost of conducting associated activities in any particular region. Efficient processes: Site management organization allows proficient tracking and management of information across enterprises. This supports greater consistency, accuracy, efficiency, and functionality in handling operations.
- Increased efficiency: It has become easier to track everyone’s efforts. In SMO all the information related to trials is stored into a safe and secure clinical management system which reduces the risk of redundancy or unauthorized access. Above given are just a few ways in which site management organization for clinical research can benefit your organization and its related operations.
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