The client is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, and consumer health products, helping pharmaceutical and biotechnology firms bring critical therapies to market.
The Challenge
The client followed a comprehensive drug manufacturing and shipment process for bulk production, packaging, labelling, and quality control. This was underpinned by stringent regulatory requirements that necessitated strict adherence to protocol with minimal margin for error.
The on-floor processes, including lot assignment, quality control, label printing, and packaging, were manual, resulting in higher turnaround times that delayed dispatches to investigation sites. Clinical trials operate within strict time windows for drug administration, and any delay can potentially derail these efforts. The manual processes also contributed to operational inefficiencies, as protocols had to be followed for each shipment, regardless of the batch size.
The client struggled to effectively meet demands for mid-trial drug changes or ad hoc requests, which required reinitiating the process from the start. These avoidable delays led to clinical wastage, as drug quality is also time-dependent. The lack of demand predictability led to inaccurate stocking, further adding to clinical wastage.
The client turned to Persistent to help improve its manufacturing efficiency, reduce clinical wastage, boost on-floor productivity, and support its customers with timely shipments.
The Solution
With a legacy spanning more than three and a half decades in engineering and deep domain knowledge of clinical manufacturing, Persistent prioritized automating the end-to-end execution of the client’s manufacturing processes, from sourcing to shipment. With automated workflows, the on-ground teams can digitally sign off at each phase and build visibility across the product lifecycle. Automation also streamlined the process, reducing turnaround time and enhancing inventory management.
The client already had a customized Salesforce.com based supply chain management solution to create electronic forms required at various stages of the manufacturing process. The solution integrates with cross-departmental databases, enabling Persistent to convert these forms into pre-filled, digitized versions that capture relevant details, considerably reducing the effort for every batch and lot assignment. The teams only had to verify details and fill in the particulars. These forms can also be used to fill and print labels at the end of the manufacturing process, eliminating the need for manual label creation, reducing turnaround times, and margin of error. For fast-moving drugs, Persistent created a cloud-hosted database of pre-filled forms to slash time to shipment. This drastically reduces manual touchpoints, enabling the client to ship small batches quickly with minimal data entry, giving the client the flexibility to meet mid-study drug requirements in record time. The process ensures compliance with regulations and adherence to necessary protocols, while helping boost clinical trial success rates.
The Outcomes
With automated execution and low-touch workflows, the client was able to:
- Reduce clinical wastage by 10x
- Reduce turnaround time from sourcing to shipment from weeks to days
- Improve customer satisfaction and clinical trial success rates by 25-30% by catering to drug requirements in record time
- Adhere to regulatory compliance with audit trails and log-based evidence generated with automated workflows
- Increase on-floor efficiency with fewer human touchpoints and significantly reduced window for errors by 25-30%
