Transitioning to Computer Software Assurance from Computer Systems Validation

By |2022-03-29T09:57:35-04:0003/29/2022|

Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]

Event Recap: Building High-Touch Patient Supply Chains

By |2022-03-18T10:36:32-04:0003/18/2022|

Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

Personal Information Protection: Broader than You Think

By |2021-11-02T10:12:07-04:0011/02/2021|

National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally, federal regulations are now in place to safeguard protected health information (PHI). A few examples of such laws active today are the General Data Protection Regulation by the European Union, the California Consumer Privacy [...]

Building Supply Chains & Systems for High-Touch Operating Models

By |2022-02-08T10:23:29-05:0008/04/2021|

Converge develops commercial supply chain business processes, commercial systems architecture & last mile strategies. Our client was an emerging pharmaceutical company focused on rare diseases, in clinical trials with an ultra-orphan drug. There were two competitive therapies also in development, so they began preparations for commercial launch on a compressed timeline to [...]

Info Sheet: IT Roadmaps for Commercial Launch

By |2021-04-08T12:51:45-04:0004/08/2021|

After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for their first commercial launch. As this organizational transformation nears, the focus of the IT organization shifts from infrastructure and help desk support to business enablement as new functions like Sales, Medical Affairs, [...]

Info Sheet: Scaling & Sustaining Commercial Growth

By |2021-03-22T09:29:03-04:0003/18/2021|

As life science companies advance beyond the first launch of commercial products, strategic focus shifts. Attention moves to expanding the business, regulatory and geographic reach of their treatments. Market expansion, label expansion, and further pipeline development create more opportunities. Companies pursue these efforts in parallel as quickly as possible. The initial supply and [...]

Managing the Unexpected in Commercial Launch Planning

By |2022-02-08T10:27:08-05:0004/12/2019|

Managing the Unexpected in Commercial Launch Planning 2 Treatments, 1 Timeline Service Areas: Commercial Launch, Supply Chain, Quality, Enterprise IT Solutions, Commercial Systems, CRM, Medical Affairs Lifecycle Stage: Clinical Our client was an emerging biopharmaceutical company formed to commercialize a rare disease treatment in late-stage [...]

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