White Papers

  1. The Role Of The CRO In Effective Risk-Based Monitoring

    A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.

  2. Personalized Medicine In Oncology And The Implication For Clinical Development

    Obstacles still remain in developing effective and efficient new targeted therapy agents, identifying the biomarker tests that indicate which patients will be responsive to them, and implementing them in clinical practice.


  3. Adaptive Trial Design and Implementation

    Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.

  4. Non Invasive Biomarkers Of Non-Alcoholic Steatohepatitis And Liver Fibrosis

    Understanding the non-invasive methods for assessing fibrosis range from biomarker assays to advanced imaging techniques such as transient elastography.

  5. Addressing The Unique Challenges In Rare Disease Clinical Research

    Applying ‘lessons learned’, innovative thinking, and creative problem solving to overcome unique challenges associated with conducting these studies.

  6. Demonstrating Effectiveness With Real World Evidence

    This white paper explains the role of study design in RWE, key data sources for RWE-based approaches, and some unique considerations for RWE studies.

  7. Flow Cytometry Capabilities

    How enhanced state-of-the-art flow cytometry capabilities empower flexible approaches to global clinical trials across multiple therapeutic areas.

  8. The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On US Clinical Research

    As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

  9. Considerations For Using eTools In Research: Part 11 And System Validation

    Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.

  10. Trial Results Summaries: Improving Patient Communications

    This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.