Healthcare

WHITE PAPERS AND CASE STUDIES

• Addressing A Critical Unmet Need: Considerations For Designing And Conducting Neonatal Clinical Trials

  There is significant unmet need for approved treatments for neonatal-specific conditions. With improved understanding of the unique nuances of research in this young, vulnerable population, sponsors can increase their likelihood of developing and executing successful neonatal clinical trials.

• Regulatory Perspective: Digital Health Technology Tools

  Digital health technology tools (DHTTs) can help capture patient experiences in real world settings. In addition to providing richer and more comprehensive information on how patients are functioning and feeling, DHTTs can help minimize barriers to obtaining patient experience data during clinical investigations. Read how these novel approaches and tools can support regulatory decision-making.

• Beyond Making The Part: Understanding Enhanced Qualification

  Working with a micro molder to develop an Enhanced Qualification (EQ) process for critical parts can save money and time by ensuring a smooth transition into full-volume production.

• Is Your CMO Ready For Serialization And Aggregation?

  While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

• Process Monitoring, Data Management Approaches For Bioprocess Challenges

  Setting up systems to automatically compile data and analyze it on a routine basis versus just collect it reduces workloads, provides timely access to critical information, and allows for data-driven decisions.

• 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.

• 3 Development Principles For Advanced Biopharma Tubing: Part 1

  Tubing is arguably one of the earliest components in pharma to be associated with single-use technology. This paper espouses active risk mitigation and cleaner materials in single-use tubing applications.

• Understanding Robust Wireless Communications For Industry 4.0

  Industry 4.0 is the new industrial revolution where existing systems are networked together to create cyber-physical systems. It is built on a reliable communications infrastructure enabling data extraction from machines, factories, and field devices to be sent to the cloud for aggregation and processing. This white paper discusses the importance of creating reliable wireless communications systems for Industry 4.0 and offers considerations for improving network coverage.

• 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.

• Overcoming Common Challenges Of Clinical Data Review

  Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources in order to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.

• Courts Across An Entire U.S. State Go Digital With Document Capture Solutions From Alaris

  Judicial system that spans hundreds of jurisdictions – from village to supreme courts – purchases thousands of scanners to save time and money, and enable online access to information.

• True Partnership, Truly Simple Integration

  The Client was looking for a single entity to interface with for integrated payments. In the past, their vendors required an inordinate amount of reconfiguration and setup for each unique account. The Client was looking to streamline this process by partnering with an organization that could deliver a seamless and simple configuration for additional clients. Additionally, the Client was hoping to partner with an organization that could offer good rates and a financial incentive.