Clinical Data Management Applications & Studies

  1. Solutions For The Strategic Assessment Of Clinical Data In Trial Operations 8/29/2017

    Achieve clinical trial operations excellence using this an innovative solution that gives clinical operations organizations the unprecedented ability to reduce the time, cost, and risk of running clinical trials while accelerating time to market for products across the entire portfolio of clinical candidates.

  2. eCOA Supports Successful Antianginal Trial 8/27/2017

    Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.

  3. Electronic Columbia Suicide Severity Rating Scale Included In A Wider Range Of Clinical Studies 8/25/2017

    The objective of this study was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device. The results supported the validity and reliability of the new tablet-based electronic Columbia-Suicide Severity Rating Scale and allow its inclusion in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data.

  4. Celgene Leverages ERT eCOA Data for FDA Approval 8/24/2017

    A biopharmaceutical company wanted to determine whether patients treated with an oral inhibitor of phosphodieasterase-4 (PDE-4) would show improvement in signs and symptoms of PsA. They used ERT eCOA tablets to collect data about patient symptoms as observed by physicians through the ACR assessment which was used to assess efficacy. Results showed reduced monitoring time and costs, decreased time to database lock, and FDA approval.

  5. Alnylam Puts Sites And Patients First With IQVIA Technologies Investigator Site Portal

    When Alnylam Pharmaceuticals began developing medicines for rare diseases with few or no treatment options, the company’s leaders knew they needed to design clinical trials that kept patient well-being and disease burden at the forefront.