Clarkston Consulting

Clarkston Consulting is a consulting firm whose life sciences practice spans quality and compliance, enterprise strategy, technology implementation, data, clinical operations, and commercial consulting.

Quality and compliance operations

• Manage quality systems and inspection preparation through QMS design and implementation, gap analysis, task planning, mock-inspection logistics, inspection training, and subject-matter support.
• Address GxP and system assurance needs through compliance consulting, CAPA and corrective-action planning, computer system validation and CSA support, data integrity programs, quality risk management, and controlled SOP development.

Strategy, transformation and transactions

• Set digital, AI, organizational, and operating-model direction through AI readiness assessments, data-strategy planning, organizational design, spans-and-layers assessment, and strategic planning sessions.
• Support growth and change initiatives through due diligence and M&A advisory, acquisition integration planning, post-merger transformation, and organizational- and brand-level commercial launch strategy.

Platforms, data and enterprise operations

• Implement and manage life sciences technology, including Veeva application management across Vault, CRM, and quality platforms, SAP S/4HANA deployment through the Life Sciences Accelerator for S/4HANA, and the Cell Therapy Orchestration Platform (CTOP) for chain of identity, chain of custody, patient scheduling, and manufacturing coordination.
• Establish data foundations through ETL pipelines, data integration workflows, cloud data warehouse and data lake configuration, and governance work that defines data ownership, oversight, and processes. Clarkston also provides procurement transformation and strategic sourcing consulting, application managed services, and cybersecurity services.

Clinical and commercial execution

• Help sponsors select CRO and CMO partners, define project scope and business requirements, and set up oversight that tracks performance metrics and critical success factors.
• Support commercial teams with sales-force effectiveness visibility, commercial reporting and analytics, HCP targeting, segmentation and call planning, and social listening.

Best Fit

• Life sciences organizations that need consulting support across regulated quality operations, inspection readiness, validation, data integrity, and quality-system implementation.
• Teams planning enterprise transformation, M&A integration, digital or AI strategy, SAP or Veeva programs, clinical partner oversight, data foundations, or commercial operations.