Comprehensive Clinical Services

Helping you manage your entire clinical operations process from
Phase I through regulatory submission.

Clinical Quality Management Systems

A Clinical Quality Management System (CQMS) incorporates industry best practices that can be applied to clinical processes from research through study management. It creates the framework for delivering the right outcome, mitigating and managing risk, and continually improving the process.

CQMS optimization can help you reduce startup time, manage risk in your studies, and store your results safely.

USDM Life Sciences provides comprehensive clinical services and technology solutions that help your life sciences company manage its entire clinical operations process from Phase I through regulatory submission.

Clinical Study Standardization

USDM’s methodology for standardizing clinical studies can save you time and money during clinical trials startup. We’ve helped companies cut study startup time by more than 50% and reduce database lock time from 40 days to 14 days. We accomplish this by:

• Selecting a single vendor for all studies
• Defining core standards that can be used across studies
• Building and testing core study components
• Developing a process for creating study-specific designs

Integrating Efficiency and Quality in Clinical Trials

Clinical trial processes can be labor intensive, that’s why we offer cost efficient solutions to streamline the phases of development. From clinical user acceptance testing to validation services to clinical portals, USDM provides the support you need to successfully manage your clinical trials.

CQMS Quality Control

USDM has more than 20 years’ experience in the life sciences industry and has developed best practices for quality control in your CQMS, including:

• Study-specific user acceptance testing (EDC, IVRS, and ePRO)
• Clinical and investigator portal solutions
• Process analysis, improvement, and management for clinical operations
• Clinical systems integration and validation
• Vendor selection

Drug Safety and Pharmacovigilance

Reconciliation between clinical and drug safety databases is necessary to ensure accuracy in collecting and reporting safety information to regulatory authorities.

USDM authors clear documentation and develops drug safety processes that support comprehensive drug safety solutions. We also offer system maintenance services to ensure your continuous compliance.

Drug Safety and Pharmacovigilance Services

You can trust USDM’s industry expertise when you need:

• Protocol reviews
• Serious Adverse Event (SAE) reporting and reconciliation
• Safety database development, change control management, and user acceptance testing (Argus, ARISg)
• Standard Operating Procedure (SOP) development

Quality System Services

• Standard Operating Procedure (SOP) development
• Vendor and system evaluations, selection, and management
• System design, implementation and validation, and maintenance for:
  • eTMF (electronic Trial Master File)
  • CTMS (Clinical Trial Management System)
  • CDW (Clinical Data Warehouse)
  • eDC (electronic Data Capture)
  • IRT (Interactive Response Technology)
  • eCTD (electronic Common Technical Document)
  • ePRO (electronic Patient Reported Outcomes)
  • eDMS (electronic Document Management System)
  • Safety (Safety Database)
  • Secure Data Server

Optimize your CQMS with USDM

Our clinical expertise has helped hundreds of companies migrate and optimize their systems for 21st century innovation and computing. Contact us to learn how we can help improve your clinical quality management system.