Healthcare

WHITE PAPERS AND CASE STUDIES

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

  Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, 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 these remarkable therapeutics.

• Ensuring Everything is A-OK At AKBA

  With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical their equipment and systems meet the strict operational needs of the manufacturing systems used by their clients.

• Automated Cash Management Technology Becomes A Time Saver For Pennsylvania Hardware Store

  Sometimes seeing is believing. Just ask the owners of Quincy Hardware in Waynesboro, PA, who were so impressed with a demonstration of APG Cash Drawer’s SMARTtill ® Intelligent Cash Drawer Solution that they simply had to have it. Never mind that the store had just deployed two brand-new cash drawers a year earlier.

• Lucky CRAs. Getting Automated To-Do Lists For Targeted SDV

  Data managers at Lotus Clinical Research used to spend hours each week building reports to identify the patients and forms that needed Source Data Verification (SDV) at the next site monitoring visit. To tackle the problem, Veeva Vault EDC introduced QuickView, a dynamic interface that optimizes the display of data by function, allowing users to focus on what matters most.

• Overcoming Clinical Data Aggregation Challenges

  Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics,  as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

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

  Complex unstructured data migration tests healthcare payments company.

• The Integrated Pharmaceutical Development Platform: Transform The Commercialization Of Innovative Therapeutics

  This whitepaper introduces the concept of the electronic Development Record (eDR) and how a holistic, platform approach to the capture, management and re-use of product and process data can propel the development process forwards, reduce costs, improve quality and enhance corporate image.

• CFO’s Guide To Field Service Management Software

  Service-driven companies are being tasked with not just creating revenue growth, but generating more profitable revenue growth. Learn how field service management software can enable top-line revenue growth, improved customer retention, and a recurring return on investment.

• Agile Process Development In Biopharmaceuticals

  A lack of consistency in the capture, management and analysis of data is a barrier to both collaboration and understanding, and hampers the development of novel products and processes.

• How To Build A Modern Field Service Technology Stack

  To enable your field service organization to serve your customers better and faster, you need to utilize modern technology that defines and supports the execution of established processes and provides the flexibility required to evolve when those processes change. Doing so improves operations and customer satisfaction immediately, but it also positions your field service organization for long-term growth.

• Ensuring Compliance With Part 11: A Site’s Perspective

  As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

• 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.