Application Notes & Case Studies

  1. eCOA Provider Collaborates With Hospital To Create Electronic Version Of The Neurostatus-EDSS

    Examine how the electronic Neurostatus-EDSS replaces the way data is captured in the traditional assessment that requires EDSS raters to complete paper forms that suffer from all the typical issues with inter- and intra-rater reliability.

  2. Breakthrough-Designation Increases Stress On Clinical Supply Chain

    While Andexanet Alfa’s Breakthrough Designation added additional stress to the supply chain, Portola and Sherpa navigated these issues by devising fast, flexible and responsive approaches to supply chain management.

  3. Japanese Sponsor Sources Partner For End-To-End Pharmacovigilance Case Processing

    Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.

  4. Solution Delivers Compliance Assurance To An Emerging Pharmaceutical Company's Quality & Regulatory Team

    Medidata RCM provided Zosano Pharma with a unified solution for standard operating procedure (SOP) management, for both regulated and non-regulated content eliminating their old system of using a file server system with folders containing PDF documents that needed to be tracked and traced manually.

  5. Transforming Clinical Development

    To enable the completion of clinical trials as safely, efficiently and quickly as possible, PerkinElmer Informatics’ clinical solutions streamline clinical trial data visualization and analysis with real-time access to clinical data in all phases of clinical development.

  6. Achieving Clinical Operations Excellence

    Learn how PerkinElmer’s clinical solutions give clinical operations organizations the unprecedented ability to reduce the time, cost and risk of running clinical trials while accelerating the time to market for products across the entire portfolio of clinical candidates.

  7. Solutions For The Strategic Assessment Of Clinical Data In Trial Operations

    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.

  8. eCOA Supports Successful Antianginal Trial

    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.

  9. Electronic Columbia Suicide Severity Rating Scale Included In A Wider Range Of Clinical Studies

    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.

  10. Celgene Leverages ERT eCOA Data for FDA Approval

    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.