Services

Comprehensive end to end Program and Project management, with focus on supporting end users through successful adoption of each fit for purpose solution.

Services include:

• -Business Case Definition
• -Proposal and Solution Identification
• -Implementation Planning and Execution
• -Organizational Change Management, Communications and Training

• GxP/21 CFR Part 11 Compliance Audits
• CTMS
• eTMF
• EDC
• CDR/SCE (Biostats)
• PV Clinical Operations Processes
• Systems and process strategy for Mergers and Acquisitions, Divestments

We specialize in management  of compliant, validated system implementations that meet audit scrutiny related to agency requirements.

We provide expertise and guidance around strategic operational and business process gap analysis and opportunity identification.