Lomic Services provides active site monitoring services to ensure that all participating research sites operate in continuous compliance with applicable study protocols, regulatory requirements, and institutional standards. Our monitoring activities are conducted in accordance with international guidelines for clinical and public health research.
Routine site monitoring visits
We conduct scheduled and unannounced site monitoring visits as defined by the study monitoring plan. During these visits, our monitors review informed consent documentation, case report form (CRF) completion, source data verification (SDV), investigational product accountability (where applicable), and adherence to protocol procedures.
Protocol deviation management
Where deviations from the study protocol are identified, Lomic Services documents and classifies each deviation in accordance with sponsor-defined criteria. We work with site personnel to identify root causes, implement corrective and preventive actions (CAPAs), and track resolution to closure.
Regulatory correspondence support
We assist sites in preparing and submitting required notifications to institutional review boards (IRBs), ethics committees, and regulatory authorities, including annual progress reports, protocol amendment submissions, and serious adverse event (SAE) notifications where required.
Capacity building & support
Beyond monitoring, Lomic Services provides direct technical support to site investigators and coordinators, including on-site training, protocol clarifications, and operational guidance to strengthen site performance and reduce the risk of major compliance findings.
Primary audience: Sponsors, CROs, and institutional review bodies requiring independent, third-party monitoring oversight across Nigerian and pan-African research sites.