USDM

For more than a decade, USDM has been helping Life Sciences companies reduce and mitigate regulatory exposure across the enterprise.  This is accomplished through our deep domain knowledge and years of experience spanning Life Science business processes and the supporting technology and infrastructure, and by a thorough understanding of the issues and best practices surrounding FDA compliance and systems validation.

Services

USDM consulting professionals are experienced across Clinical Trial and Data Management, Adverse Event Reporting, and Drug Safety business functional areas. Using best practices aligned with current regulatory trends, USDM’s compliance approach focuses on risk-based decisions and mitigation, and on reduction of wasteful non value added activities to accelerate the compliance and validation process and lower the total cost of compliance ownership.

USDM works closely with our clients to assure that all compliance requirements are met across a broad group of technology solutions including e-submission systems, CDMS and CTMS, wireless data collection, electronic data capture, IVRS/IWRS, and ePRO/patient diaries. Whether you have a new implementation, a technical upgrade, or ongoing operational use of a regulated system, USDM’s approach will simplify and optimize compliance and validation across the enterprise value chain.

Validation Accelerator Pack (VAP)

USDM’s VAP is an industry best practice ‘accelerator’ solution which simplifies compliance, increases productivity, and reduces the total cost of compliance ownership. All USDM VAP’s are developed in alignment with the principles of GAMP and current regulatory and industry best practices. The VAP provides application-specific content and a complete framework to quickly generate validation evidence based on specific deployment use case requirements. The VAP’s pre-configured framework outlines the validation plan, defines pre-populated specifications, provides executable validation protocols, and assures traceability by linking test cases to requirements.

VAPs available for Oracle applications include Oracle Clinical, Remote Data Capture, Thesaurus Management System, Clinical Trial Management System, Argus & AERS safety and pharmacovigilance systems, and Phase Forward products

Contact USDM today to discover the ways in which our team of experts can help you effectively develop and validate your clinical trial, safety, and pharmacovigilance systems and processes to ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants, stakeholders, and reputation

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