Application Notes & Case Studies

  1. A Top 10 Sponsor Improves Trial Data Quality Through EDC eSource Solution
    9/4/2018

    Be viewed as an industry leader while at the same time benefiting from higher quality data and a need for fewer resources with use of an innovative eSource solution.

  2. Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company
    9/4/2018

    Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.

  3. Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company
    9/4/2018

    PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.

  4. Taking On Both Animal Health And Human Clinical Trials With One eClinical Platform
    8/18/2018

    How a CRO is leveraging the eClinical versatility necessary to succeed in a broad array of studies.

  5. New Temperature Management Strategy Ensures GDP Compliance And Patient Safety For Large Pharma Company
    8/9/2018

    In the world of clinical trials and GxP activities, without documented evidence of an event, you cannot confirm what really happened. Learn how one large pharmaceutical customer, at risk of non-compliance to GDP due to a downturn in temperature data, improved their monitor compliance upload rate.

  6. Cellular Therapy Studies: 7 Common Challenges
    8/1/2018

    Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.

  7. New Packaging Strategy Optimizes Supplies And Prevents Break In Enrollment
    7/24/2018

    Direction from a solution provider with expertise in forecasting, packaging, labeling and distribution along with services of an IRT provider solves drug shortage challenge.

  8. Microsatellite Instability Assay For Response To Immunotherapy
    6/22/2018

    MSI assay for sensitive detection of 5 mononucleotide repeat markers in tumor FFPE specimens.

  9. Immune Landscape Signatures For Characterization Of Tumor Microenvironment And Response To Therapy
    6/22/2018

    Gene expression and analysis for detection of 11 Immune Landscape Signatures.

  10. Altus Research Maximizes Efficiency With eSource
    5/31/2018

    By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.