White Papers

  1. Optimizing Rare Disease Outcomes Through eCOA Technology And Training

    Read how utilizing electronic data capture systems ─ including eCOA ─ and training site raters, subjects and caregivers are important tools to ensure high quality data capture in rare disease research.

  2. Confronting The Challenges Of Rare Disease: Finding Solutions Across The Entire Product Life Cycle

    A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

  3. The Impact Of Rater Training On Clinical Outcomes Assessment Data

    Review the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data. 

  4. Applications For Genomic Technologies In Immuno-oncology

    Genomic- based biomarkers are powerful tools used to assess tumor mutational burden, production of novel or neo- antigens and hallmarks of genomic instability, which may be useful as measures of response or resistance to immune therapies.

  5. Addressing eCTDs And New Regulatory Standards For Pharmaceutical Advertising And Promotional Materials

    This requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.

  6. 10-Step Commercial Clinical Protocol Authoring Guide

    Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

  7. Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry

    Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.

  8. Clinical Data Aggregation

    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.

  9. Speeding The Switch To Risk-Based Monitoring

    The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.

  10. The Foundation Of Risk-Based Monitoring Success

    Proponents of RBM projects believe that the investment in this approach will return an overall reduction in monitoring expense by 15 to 20 percent. This paper discusses RBM as a high-value use case that can be enhanced by a robust clinical data aggregation and analytics solution.