A Site Management Organization (SMO) is a professional entity that manages and supports clinical trial sites on behalf of sponsors and Contract Research Organizations (CROs). We provide operational, regulatory, and administrative services to ensure high-quality, efficient, and compliant trial execution at the site level. An SMO is sometimes referred to as an Integrated Site Organization or Site Network.

While CROs oversee overall clinical trial management on behalf of sponsors, SMOs focus specifically on the operational management of clinical sites. We ensure sites are well-staffed, trained, compliant, and performing optimally often bridging the gap between sponsors/CROs and investigators.

Our SMO provides a full spectrum of site management services, including:

·       Feasibility and site selection: Rapid site identification through a pre-qualified investigator network

·       Study start-up: Contracting, budget negotiation, and ethics/regulatory submissions

·       Site management and monitoring support: On-site and remote coordination, data entry facilitation, visit readiness

·       Recruitment and retention: Pre-screening via EMRs, digital outreach, databases, and retention programs

·       Training and compliance: Continuous GCP and protocol-specific training

·       Quality management: Routine internal audits

·       Finance administration: Streamlined site payments and budget management

We work with pharmaceutical companies, biotechnology firms, and CROs, as well as individual investigators and hospital research departments looking to enhance their clinical trial capacity and efficiency.

Key advantages include:

·       Faster site start-up and enrollment

·       Consistent quality and compliance across sites

·       Streamlined communication between sites and sponsors

·       Reduced administrative burden for investigators

·       Improved patient experience and retention

Our operations follow ICH-GCP, local regulatory requirements, and sponsor-specific SOPs. We conduct routine quality checks, staff training, and internal audits to maintain data accuracy and regulatory compliance.

Yes. While we manage a diverse portfolio of studies, we have deep expertise in cardiology, dermatology, endocrinology, OB/GYN, psychiatry, rheumatology, and sleep medicine. Our network includes specialized investigators and facilities in these fields.

Our network currently includes ten active research sites across the United States and is growing.

We use data-driven recruitment strategies, including electronic medical record (EMR) pre-screening, community outreach, patient registries and databases, and digital engagement tools – all while ensuring ethical and privacy-compliant practices.

We leverage secure digital platforms for eRegulatory, eSource, CTMS, and patient engagement, ensuring real-time oversight, compliance, and efficiency across sites.

Yes. We welcome qualified investigators and research sites interested in partnering with us. Joining our network provides access to trial opportunities, operational support, and training resources.

Sponsors and CROs can reach out via our contact us form to discuss site network capabilities, therapeutic expertise, and partnership models. We tailor collaboration agreements based on project scope and needs.

Our strengths include:

·       Deep investigator relationships and retention

·       Quality management systems

·       Transparent communication and performance tracking

·       Proven track record of accelerated enrollment and high data quality

Expanding access and improving representation in clinical research is a core focus of our network strategy. We actively partner with community-based healthcare providers, public hospitals, and clinics that serve historically underrepresented populations. We work to enable sponsors and CROs to meet both regulatory expectations (e.g., FDA/EMA diversity guidance) and ethical imperatives for inclusive research.