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Clinical and Drug Safety

ClinicalAutomationUSDM consulting professionals are experienced across the Clinical Value Chain, Adverse Reporting, and Drug Safety Lifecycle. Using a current best-practices approach, aligned with regulatory audit trends, UDMS’s approach expedites the compliance process and minimizes costs.

Our professionals work closely with client representatives, software engineers and end-users to ensure that requirements (e.g., business, functional and compliance requirements among others) are properly articulated for efficient verification and testing while minimizing execution time and cost.

USDM works closely with our clients to assure all compliance requirements are met from eSubmission system compliance, CRF verification, CDMS verification, wireless data collection; remote data capture, IVRS/IWRS, ePRO/patient diaries, and Clinical Trial Supply Management and CTMS verification.

Contact USDM today to discover ways in which our team of experts can help you effectively develop and validate your clinical trial management system, electronic submissions processes and pharmacovigilence system to ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants and reputation.

To learn more about USDM and how we can assist with your compliance and business objectives, please contact:

Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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“Simplify, Unify and Optimize your business & compliance needs with USDM”

 

About USDM

USDM is a leading global consulting firm focused on life sciences.  We specialize in regulated business processes, with an emphasis on compliance and performance.

USDM provides innovative services and solutions that enable life science companies to achieve and maintain compliance across the entire enterprise.