Lab 4.0 for CROs – Operations and Supply Chain Management Perspective

By: Komal Hatti, NCARB, LEED AP
SME R&D, Sr. Process Architect
IPS-Integrated Project Services, LLC

Pharmalucence_IMG_0100 Lab

The advancements in data analytics and ever-increasing competitive forces are driving more laboratories than ever before to adopt lean and Industry 4.0 principles. Once considered luxury items, they are quickly becoming a necessity for the process-driven labs owned by Clinical Research Organizations (CROs). CRO labs align with a more traditional manufacturing operation in their need for highly efficient operation and cost-competitive environment; they are at a point where the benefits of Lab 4.0 cannot be ignored.

As we enter the fourth phase of the Industrial Revolution, CRO labs will undoubtedly be the early adopters of smart lab technology solutions that integrate all instruments, samples, reagents, consumables and researchers under a single server and technology platform. In order to create an effective 4.0 platform, labs need to create a framework by which the lab operations teams can effectively evaluate resource utilization, and customize the lab management server to eliminate waste to the greatest extent possible.

This framework for analysis, synthesis, and design must be developed using operations and supply chain management (OSCM) principles. To ensure success, we need to follow these guiding principles:

  • Data-driven view of the firm’s business;
  • A strategy that is consistent with the operations-related priorities of the firm; and
  • A comprehensive and long-term approach to 4.0 implementation.

Tactical and operational steps in implementing Lab 4.0 follow lean principles, utilize Internet of Things, and use modern data analytics to develop an optimal performance model that maximizes profitability by minimizing waste. CROs must be patient as this process is complex and tedious. A hasty implementation without an underpinning of the OSCM principles will lead to disappointment and capital loss.

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