Post Merger Integration: Introduction

SSI Strategy focuses on ensuring business continuity in your critical safety and medical systems while planning and implementing efficient data and process integration. Our extensive Post-Merger Integration (PMI) Services experience coupled with domain expertise in Pharmacovigilance, Quality, Clinical Operations, Regulatory Affairs, and Medical Affairs allows us to lead and support your integration activities with minimal distraction and maximum risk reduction. We protect your company and your patients.

Challenge

Maintain Sufficient Staffing And Performance Of Safety Activities In Order To Prevent Increased Patient Safety Risk During Integration.

Challenge

Ensure Business Continuity With Respect To Patient Safety, Regulatory, Medical Affairs, Clinical Trials, And Quality.

Challenge

Integration Activities Are Likely To Be Reviewed During Subsequent Inspections And Can Create Compliance Risk.

Challenge

Ensure That All Interdependencies And Related Business Functions Are Appropriately Integrated And Aligned With Business Goals.

Solution

Carefully Assess The
Required Processes And Technologies Within Each PV System

Create and execute a robust integration plan, identify and close any critical safety or compliance gaps, and prevent interruption in data submission. 

Solution

Develop A Forward
Looking Implementation Plan

Include embedded risk minimization elements, which align with critical business strategies and objectives and ensure consistency across all markets. 

Solution

Plan Carefully

Document steps taken to complete the integration and ensure that all previously identified findings have been addressed and closed. Develop and implement remediation plan as needed.

Solution

Develop A Detailed
Communication Plan

Identify all parties, key messages, and critical interdependencies that must occur pre and post integration.

+ Challenge - Maintain Sufficient Staffing And Performance Of Safety Activities In Order To Prevent Increased Patient Safety Risk During Integration.

Create and execute a robust integration plan, identify and close any critical safety or compliance gaps, and prevent interruption in data submission.

+ Challenge - Ensure Business Continuity With Respect To Patient Safety, Regulatory, Medical Affairs, Clinical Trials, And Quality.

Include embedded risk minimization elements, which align with critical business strategies and objectives and ensure consistency across all markets.

+ Challenge - Integration Activities Are Likely To Be Reviewed During Subsequent Inspections And Can Create Compliance Risk.

Document steps taken to complete the integration and ensure that all previously identified findings have been addressed and closed. Develop and implement remediation plan as needed.

+ Challenge - Focus on developing a model that encourages continuous personal development and establishes a high functioning ambitious team and ultimately a performance driven culture.

Identify all parties, key messages, and critical interdependencies that must occur pre and post integration.

SSI Strategy staff have designed and led post-merger integration teams in both large and small pharmaceutical and biotech companies. We use our unique blend of pharmacovigilance, medical, and consulting capabilities in tandem with our proprietary toolkit to develop a comprehensive integration plan with supporting customized tools and documentation. We will employ our phased approach to PMI that is tailored for the specific needs of our clients.

Post Merger Integration: Methodology

Assess

A strong understanding of both organization's existing operations, strengths, and weaknesses is key to long-term success. SSI Strategy will complete a full assessment of all current systems, processes, compliance requirements, and existing contracts to guide a customized approach moving forward.

Design and Plan

SSI Strategy will create an end-to-end integration roadmap that ensures all safety and related systems meet stakeholder and industry requirements. All operational gaps and identified risks will be addressed while maintaining patient safety and ensuring inspection readiness post-integration.

Implement

Flexible implementation is critical to success. We focus heavily on change management and we empower organizational change leaders as part of our integration efforts. We ensure the engagement of broad-based corporate leadership to increase awareness of the contributions of the integration teams.

Maintain and Refine

Quality management elements incorporated into the design allow leaders to monitor and manage success post integration. The systems measure hard metrics such as regulatory compliance, as well as softer elements, such as post-merger team culture and performance sentiment, or the impact of medical affairs initiatives.

Post Merger Integration: Toolkit Summary

SSI Strategy’s proprietary Post Merger Integration Toolkit provides best known practices and lessons learned, highlights key decision points based on size and scope of the integration, and supplies clients with templates, checklists, and supporting documentation to use throughout the integration. Throughout our approach, these tools will be accessible and customized to meet our client’s needs.

Post Merger Integration: Case Study

For more information on how SSI Strategy can prepare your company for integration, please review our Impact Study