Site Management Organization (SMO)

Site selection and feasibility: We assist sponsors and contract research organizations (CROs) in identifying suitable research sites for specific clinical trials. They conduct feasibility assessments, evaluating the site's capabilities, patient population, infrastructure, and experience in relevant therapeutic areas.

Site startup support: We help research sites with the administrative tasks involved in trial initiation. This includes facilitating contract negotiations, obtaining necessary approvals and regulatory documents, and ensuring site personnel are trained on study protocols and procedures.

Study management: We provide comprehensive study management services, overseeing all aspects of trial conduct. This includes protocol adherence, patient recruitment and enrollment, data collection and management, adverse event reporting, and ensuring compliance with good clinical practice (GCP) guidelines.

Regulatory compliance: We help sites navigate the complex regulatory landscape by providing guidance and support in meeting regulatory requirements. They ensure that sites maintain compliance with local and international regulations, ethics committee approvals, and protocol amendments.

Patient recruitment and retention: We develop and implement strategies to enhance patient recruitment and retention at research sites. This includes utilizing targeted advertising and outreach campaigns, managing patient databases, and implementing retention programs to improve participant compliance and study completion rates.

Quality assurance: We assist sites in maintaining high-quality standards throughout the trial. They conduct regular monitoring visits to ensure protocol compliance, accurate data collection, and adherence to GCP guidelines. SMOs also help sites address any audit findings or non-compliance issues.

Data management and monitoring: We offer expertise in data management, ensuring accurate and timely collection, validation, and reporting of trial data. They may provide electronic data capture (EDC) systems, train site staff on data entry procedures, and conduct remote or on-site monitoring visits to verify data quality.

Financial management: We assist sites in managing the financial aspects of clinical trials. This includes negotiating study budgets, tracking site payments, and ensuring timely reimbursement for study-related activities.

Training and education: We provide training and educational programs to enhance the capabilities of site staff. This can include GCP training, study-specific training, and ongoing education to keep sites up-to-date with evolving regulations and best practices in clinical research.