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Sole Proprietor / Clinical Research Company
implementation of drug safety activities: • safety profile monitoring during the conduct of phase i, phase iia, phase iib and phase iii clinical trials • signal management and assessment • analysis of safety data • contribution to safety related sections of clinical trial protocols, icfs, ib, clinical trial reports • contribution to clinical trials design • dsur review • preparation of risk profile summaries for comparator compounds • icsr review and query generation • literature review • implementation of safety recommendations • preparation of responses to requests made by regulatory authorities • etc. implementation of medical monitoring actvities: • medical monitoring development and review • guidance of the investigative sites and project team regarding protocol interpretation and medical issues • assessing and providing responses to requests related to eligibility, re-screening, extension of screening period, study treatment re-start after interruption, unblinding, concomitant
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Distro — Free Sales Engagement Platform
Sequences, cloud call center, shared inbox, form tracking and more — on a single platform. Double your sales team's output with fewer tools.
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