Global Trade Compliance: Why Emerging Biopharmaceutical Company Operations Executives Need to Take Notice

By |2021-09-30T13:18:28-04:0009/27/2021|

Today’s biopharmaceutical supply chains often stretch around the world. Key starting materials (KSM) and API originate more frequently from Asia. Manufacturing is commonly conducted in Europe and North America. And commercial distribution is spread across the globe. This globalization has resulted in increased logistics and global trade compliance (GTC) complexity along with ever-changing import/export [...]

Improving Clinical Supply Chain Management by Establishing End-to-End Visibility

By |2021-08-09T11:48:14-04:0008/09/2021|

Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One [...]

Clinical Supply Management Improved with Single IRT Solution

By |2020-10-30T11:09:36-04:0010/30/2020|

A cancer treatment company with a strong development pipeline had more than a dozen clinical studies in process and that number was growing. A lean team was managing everything and, like many emerging biotech companies, relied on CROs for many clinical operations activities. As those programs progressed through development, our client was dealing [...]

Scaling Clinical while Preparing for Commercial Supply

By |2021-05-24T13:28:50-04:0009/17/2019|

Introducing Demand & Operations Planning Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol changes affect enrollment rates, production volumes, regulatory activities, logistics and managing data. It makes planning particularly challenging for both clinical and commercial production. Our client was [...]

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