Site Management Organization for Clinical Research
Site Management Organization for Clinical Research
Large number of hospitals, well qualified and experienced doctors, very huge patient pool emblematizing chronic as well as infectious diseases, high-costsaving, and easy patient recruitment is leading India to become a lucrative hub for conducting global clinical trials. The reduced cost of conducting clinical trials in India as compared to other parts of the world, is serving as the main attraction point for many global pharmaceutical and biotechnology companies to start their operations in India.
To attract more pharmaceutical companies for outsourcing their clinical trials to India, the importance of Site management Organization (SMO) comes into picture. As the name ‘site management organization’ itself states, it is an organization that specializes in managing clinical research sites. SMOs are service providers for Contract Research Organizations (CRO’s), pharmaceutical companies, biotechnology companies, medical device companies and even clinical research sites.
Shubhdisha Business Solutions is the Site Management Organization acts as a common platform between the Principal Investigator(s) and Sponsor(s)/CRO(s) for the triumphant execution of clinical trials. I Our team brings more than 50 years of collective experience in clinical research.
Our highly competent Project Management Team and Clinical Research Coordinators at each study site assist and support the investigators with all study related activities, ensure compliance with applicable regulations, ICH-GCP, New Drugs and Clinical Trial Rules 2019 guidelines and efficient completion of assigned duties. Our CRCs have adequate operational knowledge of the research process, strong personal ethics, and clinical competency.
SBS claim strict adherence to protocol, compliance to regulatory norms, extensive documentation, absolute accuracy, an ethically sound patient recruitment strategy, and efficient site management through our well laid Site Management specific Standard Operating procedures (SOPs). Our Site Management Services include but not limited.
- Assistance in site Feasibility assessments and Site Contracts
- IEC/ IRB Submission and Approvals
- Assist the P I in subject recruitment and retention
- PI in Assist maintaining the Site Master File
- Coordinating and scheduling subject visits
- Drug accountability and dispensing
- Effective Maintenance of study related logs
- Effective followup with subjects
- Assist CRA during monitoring visits
- Drug and Samples Shipment
- Study subject’s payments
- Assist in Data Entry, Resolution of Queries and AE/SAE Reporting
- Sponsor Audits/ Regulatory Audits
- Project Management at Site