White Papers

  1. The Impact Of Rater Training On Clinical Outcomes Assessment Data
    10/4/2017

    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. 

  2. Applications For Genomic Technologies In Immuno-oncology
    10/2/2017

    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.

  3. Addressing eCTDs And New Regulatory Standards For Pharmaceutical Advertising And Promotional Materials
    9/28/2017

    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.

  4. 10-Step Commercial Clinical Protocol Authoring Guide
    9/13/2017

    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.

  5. Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry
    9/7/2017

    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.

  6. Clinical Data Aggregation
    8/30/2017

    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.

  7. Speeding The Switch To Risk-Based Monitoring
    8/30/2017

    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.

  8. The Foundation Of Risk-Based Monitoring Success
    8/30/2017

    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.

  9. Planning Quality Into Clinical Trials: Integrating RBM And QbD
    8/30/2017

    Drug developers are focusing significant attention on risk-based monitoring (RBM) of clinical trials to improve data quality, trial efficiency and patient safety. Widely encouraged by regulatory agencies, RBM adoption is gradually building momentum as sponsors and contract research organizations (CROs) concentrate on developing the right strategies, deploying the most effective technologies and internally managing change.

  10. Placing The Patient First In Clinical Trials
    8/29/2017

    This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.