Healthcare

WHITE PAPERS AND CASE STUDIES

• The Evolving Role Of The GxP Archivist

  Customers and regulators expect the highest level of data integrity. This white paper asserts that storing GLP data in the cloud is acceptable, provided certain conditions are met.

• Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

  A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

• Cloud-Based ELN Streamlines Med Device Development

  A leading medical device and in vitro diagnostics technology company's research & development scientists were using traditional paper notebooks to record all of their procedures, experimental results, and testing methods. They turned to BIOVIA Notebook— a flexible electronic lab notebook (ELN) hosted on BIOVIA ScienceCloud, a scalable cloud infrastructure. With BIOVIA Notebook, the customer was able to quickly replace paper-based processes across their R&D labs, speeding up workflows and improving data accuracy.

• How Payspan Conquered The Unique Challenges Of NAS Migrations In Healthcare

  Complex unstructured data migration tests healthcare payments company.

• Business Management Software Greatly Improves Accuracy And Provides The Tools Needed To Compete

  As a veteran of the two-way radio business with close to 20 years of industry experience, Marty Bleck knows what it takes to run a successful two-way dealership. Back in 2014, he also knew that General Communications, the company where he has served as national sales director and system administrator since 2009, needed to upgrade someof its key business resources.

• Stop Managing Paper In A Data-Driven World

  Many life sciences companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs however, paper production records and a hyper-focus on compliance remain a reality for many emerging and mid-market companies. This paper explores how companies that shift from paper to data-driven intelligence are able to better leverage manufacturing data to improve the reliability of their quality metrics and support their regulatory compliance and business improvement efforts.

• Addressing New Chromatography Challenges With Fiber Absorbents

  An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

• From Early Adopter To Optimized Trials: Cara Therapeutics And Veeva Vault CDMS

  Cara Therapeutics shares how they handle tight deadlines, complex protocol designs, and mid-study changes easily with Veeva Vault CDMS.

• Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

  This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

• Removing The Barriers To eConsent Adoption

  Electronic consent (eConsent) technology has existed for nearly 20 years in various iterations. Read how sponsors overall have taken a cautious approach to using eConsent, piloting it on individual studies but refraining from incorporating it across all pipelines in clinical operations.

• ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

  Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

• Pharma Sponsor Enlists Cenduit IRT To Rescue A Multi-Country, Multi-Site Oncology Study

  After go-live, the sponsor learned its study did not fit the existing IRT solution, affecting data quality, timelines, and drug supply shipments. The legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design. Read how Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.