MANAGEMENT CONSULTING & INFORMATION TECHNOLOGY SERVICES    FOR THE BIOPHARMACEUTICAL INDUSTRY

Strategic Guidance

Partnering with senior management to conceptualize, develop, communicate, and implement a strategic vision with translation into operational and tactical goals with tangible deliverables, ensuring the alignment of IT with business objectives.  Development of governance models, strategic roadmaps, prioritization frameworks, and PMO structures.

Process Innovation

Collaborating with business units across diverse functional areas on process modeling and business reengineering.  Team facilitation to define process goals and context, develop as-is / to-be models, activity diagramming, defining KPI’s, and composing SOP’s, SLA’s, and OLA’s.

Technology Implementation

Engaging with IT and business areas to implement technology solutions across the organization, including research & development, pre-clinical, clinical trial operations, clinical data management, commercial/sales, manufacturing, drug safety, pharmacovigilance, risk management, regulatory affairs, compliance, and quality management.  Project management and business analysis within various SDLC and PMM frameworks to produce fully documented requirements, design specifications, testing and validation for custom-developed applications and large COTS package implementations.

GxP Compliance & Data Integrity

Performing system validation, change control, quality management, audit preparation and inspection readiness to ensure compliance with regulatory guidelines such as GxP, 21 CFR Part 11, and EU Annex 11. Traditional frameworks including CSV (Computer System Validation) and GAMP 5, as well as the recent CSA (Computer Software Assurance) guidance from the FDA focusing on a risk-based approach. Cross-functional engagement to further enhance enterprise data quality and increase data integrity, both being absolutely essential to improving AI capabilities and maximizing the leverage it can provide.