At Nexiora Lifesciences, we execute clinical studies with absolute precision, strictly adhering to ICH-GCP guidelines and CDSCO regulatory standards.
Analyzing patient population, site infrastructure, investigator availability, and historical trial performance before study setup.
Identifying and shortlisting investigative sites with qualified Principal Investigators (PIs) and proper medical facilities.
Preparing study dossiers, ICF translations, and coordinating with Institutional Ethics Committees (IEC/IRB).
Securing formal regulatory approvals, CDSCO notifications, and Ethics Committee trial clearance certificates.
Deploying certified CRCs, conducting protocol training, and setting up Investigational Product (IP) storage.
Executing ethical recruitment strategies, pre-screening candidates, and obtaining Informed Consent Forms (ICF).
Managing subject visits, administering study drug/device, safety reporting (SAE management), and data logging.
Facilitating CRA monitoring visits, performing source data verification (SDV), and addressing query resolutions.
Ensuring timely Electronic Data Capture (EDC) entry, medical coding, and ALCOA+ compliant data governance.
Reconciling IP supplies, resolving open queries, and completing formal site close-out procedures.
Long-term secure storage of Master Site Files (ISF/TMF) in climate-controlled and audit-ready archives.
Partner with Nexiora Lifesciences for rapid site feasibility, certified CRCs, and flawless study execution.
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