Healthcare

WHITE PAPERS AND CASE STUDIES

• Achieving Healthy CRO Growth Through Agility

  In this case study, learn about the types of databases that were built to help endpoint adjudication research projects.

• 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.

• Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies

  A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of remarkable therapeutics.

• Container Closure Integrity Testing Of Sterile Injectable Product

  This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.

• Back On Track: Data Rescue On Pediatric Rare Disease Trial

  A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was not effectively managing the study data. As trouble mounted, the CRO quit, stranding the project at a critical point in the development cycle. Premier Research was able to step in and successfully take over the data management and statistics portion of the trial to keep the trial on track.

• Process Monitoring, Data Management For Bioprocess Challenges

  Setting up systems to automatically compile and analyze data routinely, versus compiling it, reduces workloads, provides timely access to critical information, and allows for data-driven decisions.

• Set For The Future—San Juan Water Implements Esri's ArcGIS Utility Network And Cityworks Computer Maintenance Management System

  San Juan Water District (SJWD) has used ArcGIS Utility Network as a foundation for the organization's computer maintenance management system (CMMS) implementation, which uses Cityworks. The Utility Network and the CMMS work from one centralized database for water distribution. The field crews can access the latest information and use the networking analysis capabilities for outage events via tablets in the field or a web browser in the office. The integration of these systems has improved reporting and inspection workflows while providing a single, authoritative source of truth. 

• Global Biopharma Improves Product Purity & Reduces Costs With Biovia Discoverant

  Following several mergers and acquisitions, a biopharmaceutical company had to manage an increasing amount of data from disparate online and offline sources. A solution allowed them to access data from various sources and to feed other systems with data quickly to support the company’s digital science and manufacturing informatics strategies.

• R&D Services Company Implements A Collaborative Electronic Lab Notebook

  For a this BIOVIA customer, meeting collaboration demands meant being able to rapidly collect project information to deliver reports and data, fulfill patent submissions, or leverage and build on past work.

• Accelerating SCTU’s Digital Transformation And Supporting Its COVID-19 Studies With Unified Platform

  Southampton Clinical Trials Unit was using largely manual and paper-based processes to run its studies that required multiple touchpoints and logins. As the IT support provided by the University was not specialized in clinical trials software, the SCTU team decided to move to a Software as a Service (SaaS) model to help streamline their clinical trials on a unified platform.

• Leader In Restorative Cell Therapies Embeds Skyland PIMS® As Process Knowledge Base From Clinical To Commercial Manufacturing

  A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.

• Weighing Data Integrity: 3 Ways To Ensure Compliance

  In this paper, we will compare manual transcription to documentation with three automated or partially automated solutions, assessing the pros and cons of each.