Managing a Tech Transfer Redesign Post-Acquisition

By |2024-01-29T11:02:22-05:0001/29/2024|

Managing a Tech Transfer Redesign Post-Acquisition Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally redesign their TT processes to accommodate changes in technology, regulatory requirements, clinical strategies, or other similar reasons. However, even repurposing a manufacturing facility can drive a [...]

Event Recap: Digitization of the Supply Planning Process

By |2024-02-06T13:51:53-05:0011/03/2023|

Event Recap: Digitization of the Supply Planning Process Many emerging and mid-sized biopharma companies work to digitize their supply planning process as they grow, as part of larger efforts to digitally transform and automate manual processes. In Converge Consulting’s ongoing work with clients, we have seen a distinctive gap for these companies: planning [...]

ERP Implementations: How to Ensure a Successful Business Go-Live

By |2023-09-19T09:58:20-04:0009/19/2023|

ERP Implementations: How to Ensure a Successful Business Go-Live This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the requirements of both for success. Achieving successful go-lives across both the technical and business dimensions is essential to ensuring a successful Enterprise [...]

Transitioning to Computer Software Assurance from Computer Systems Validation

By |2023-03-16T10:27:15-04:0003/29/2022|

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 [...]

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 [...]

Event Recap: Why is Now the Time for Digital Supply Chain Transformation

By |2023-06-28T11:42:26-04:0009/14/2021|

Event Recap: Why is Now the Time for Digital Supply Chain Transformation Clinical supply professionals are responsible for ensuring that patients on clinical trials receive the right drug at the right time for their treatment protocols. The environment is dynamic and challenging, so companies embrace innovation to enable educated and responsible supply [...]

Building Supply Chains & Systems for High-Touch Operating Models

By |2024-02-06T10:16:39-05:0008/04/2021|

Building Supply Chains & Systems for High-Touch Operating Models Converge develops commercial supply chain business processes, commercial systems architecture & last mile strategies. PDF Version 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, [...]

Info Sheet: IT Roadmaps for Commercial Launch

By |2024-02-06T14:58:23-05:0004/08/2021|

IT Roadmaps for Commercial Launch Info Sheet Download PDF 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 [...]

Info Sheet: Cell & Gene Therapy Services

By |2024-02-06T15:15:46-05:0003/02/2021|

Cell & Gene Therapy Services Info Sheet Download PDF Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and [...]

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