As an experienced partner, you get the proven expertise, depth, and breadth that comes from a large network of clinical trial specialists.  Our insight enables us to help clearly and rapidly diagnose challenges and issues that are often interrelated and costly to your business.  We will work with you to develop a clear action-plan that addresses the root causes of operational issues that undermine your business’s potential.

In addition, in a rapidly shifting marketplace characterized by frequent mergers and acquisitions, we can also assist with helping ensure a seamless integration of new clinical supplies units and teams.  We are experts in change management and team-building, and will work with you to help maximize your team’s capabilities and supply chain network.

 

Some of our areas of consulting expertise are:

 

• Technical – IRT, ERP systems, Integration of Systems to include planning and forecasting

 

• Clinical Supplies Project Management, Man in the plant, Manager/Coordinator

 

• Project Management (Clinical Supplies, Clinical Development, Quality System Implementation)

 

• Clinical supply plan preparation

 

• Clinical supplies packaging, labeling, assembly, storage, distribution, returns and reconciliation: Returns, reconciliation and destruction

 

• Process and material flow-charting / diagrams

 

• Process mapping

 

• Temperature mapping

 

• Risk analysis, process efficiency and gap analysis

 

• Analytical Services

 

• Qualification of analytical labs

 

• Validation of facilities

 

• Stability Program management and auditing

 

• Environmental monitoring

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• Leadership and management assessment, coaching & mentoring