Industry Insights

  1. A Proactive Approach To Ebola Vaccine Development

    Best practices for rapid test development and regulatory approvals.

  2. Study Stakeholder Collaboration Takes The Stage At DIA

    A strategy to reduce potential conflicts when working with clinical research study stakeholders.

  3. Fighting Cancer: Biomarkers For Immuno-Oncology Clinical Trials

    Using anatomic pathology for biomarker development in clinical trials can help predict and assess how a patient will respond to immuno-oncology therapies

  4. Thinking Pragmatically About The Future Of Real World Evidence

    Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.

  5. Three Things eClinical Providers Owe Their Users

    Three essential things for data managers to look for - and for technology providers like us to deliver - as clinical trial technology becomes more prevalent and diverse.

  6. Immunotherapy And PD-L1: The Future Of Precision Medicine

    Advances in precision medicine lead to new trends in immunotherapy.

  7. Using Advanced Techniques For Protein Bioanalysis

    Overcoming hurdles in a regulated setting.

  8. Five Considerations For Sites Preparing For eConsent

    Five areas to investigate to determine whether your site is ready based on the 2016 FDA-OHRP guidance about eConsents.

  9. Monitoring Clinical Trials With Electronic Informed Consent

    This article highlights some of the monitoring challenges and burdens related to informed consent for a clinical trial and explains how electronic informed consent (eConsent) can positively impact monitoring practices and documentation. The article demonstrates how oversight of data integrity and human subject protection may be improved with an eConsent solution and provides some guidance on considerations when implementing eConsent in a clinical trial to enhance the monitoring process, including saving time, reducing costs and boosting efficiencies.

  10. Trends In Oncology Trial Terminations Due To Toxicity

    Are studies focusing on elderly cancer patients at increased risk for discontinuation due to safety reasons, such as toxicity?