Contacts
Unit 863, Cospacio: Premium Coworking,
8th Floor, Celica Park, 24, Park Street Park
Center, Kolkata, West Bengal 700016
OrciVita provides end-to-end Site Management Organisation (SMO) services to ensure smooth, compliant, and efficient execution of clinical trials. We partner with sponsors and CROs to manage site operations, subject recruitment, regulatory coordination, and study documentation—allowing sites to focus on quality patient care and accurate data generation.
With strong on-ground experience, trained site staff, and adherence to ICH-GCP and Indian regulatory standards, we help accelerate trial timelines while maintaining the highest standards of ethics, compliance, and data integrity.
OrciVita provides comprehensive end-to-end site management services for Phase II to Phase IV clinical trials. We support site identification, qualification, initiation, and close-out activities across multiple therapeutic areas. Our team ensures smooth coordination between investigators, sponsors, and CROs to maintain protocol compliance. We actively manage patient recruitment, retention, and visit scheduling to meet study timelines. Robust documentation, site file maintenance, and archival support ensure audit and inspection readiness at all times.
OrciVita’s Feasibility & Study Start-Up Services are managed by a dedicated, specialized team, independent of routine clinical operations, to ensure focused and efficient study activation. The team conducts in-depth protocol and site feasibility assessments to evaluate patient availability, investigator interest, infrastructure readiness, and operational capability. We support comprehensive investigator feasibility, site infrastructure evaluation, and regulatory requirement analysis aligned with sponsor and regulatory expectations. Our experts manage ethics submissions, regulatory documentation, and study start-up approvals with meticulous attention to timelines and compliance. Through proactive planning, cross-functional coordination, and risk-based assessment, we consistently minimize start-up timelines and enable smooth, low-risk study initiation.
At OrciVita, Clinical Operations Support is the engine that keeps clinical trials moving smoothly from first patient in to final study close-out. Our trained clinical operations team works side by side with investigators and site staff, managing every patient touchpoint—from screening and informed consent to follow-up visits and study completion. We ensure that source documentation is accurate, contemporaneous, and audit-ready, while CRFs and eCRFs are completed in a timely and compliant manner. Patient safety remains central to our operations, with rigorous oversight of adverse event and serious adverse event reporting in line with protocol and regulatory timelines. Through constant coordination with sponsors, CROs, monitors, and ethics committees, OrciVita ensures seamless trial execution, strict protocol adherence, and reliable, high-quality data generation.
Quality and compliance are central to all OrciVita operations and are managed through a dedicated, independent Quality Department. We implement robust, GCP-compliant processes supported by well-defined SOPs, quality frameworks, and regulatory guidelines. Our quality systems strictly adhere to Good Documentation Practices (GDP) and ALCOA++ principles, ensuring data that is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. The Quality team conducts routine internal audits, compliance checks, and risk-based reviews to identify gaps and implement effective Corrective and Preventive Actions (CAPA). We also provide comprehensive inspection and audit readiness support for sponsor, regulatory authority, and ethics committee inspections, ensuring consistent, high-quality trial conduct across all sites.
OrciVita provides structured training programs for investigators, study coordinators, and site staff to ensure high-quality clinical trial conduct. Our training modules cover Good Clinical Practice (GCP), protocol-specific requirements, safety reporting, documentation standards, and regulatory compliance. We conduct both induction and refresher trainings to keep teams updated with evolving regulatory and sponsor expectations. Practical, hands-on training ensures effective implementation of SOPs and readiness for audits and inspections. Through continuous capacity building, OrciVita strengthens site performance, data integrity, and patient safety across all studies.
OrciVita offers end-to-end support for Ethics Committee registration and re-registration with CDSCO. We assist hospitals and institutions in EC formation, SOP development, and regulatory documentation. Our expertise includes operational support for Institutional Ethics Committees, ensuring compliance with applicable regulations. We also provide ongoing EC coordination, submission tracking, and regulatory communication support. These services help institutions maintain ethical oversight and regulatory compliance efficiently.