Clinical Data Management Applications & Studies

41. Actigraphy Motion Biosensors For Dermatology Poster Presentation 1/17/2020

    This poster demonstrates how the combination of high resolution actigraphy and advanced signal processing provides an accurate and non-invasive assessment of nocturnal scratching events.

42. Large PMA Study Of CRC Diagnostic 8/28/2019

    A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.

43. Real-Time Monitoring Of The Digital Patient In Clinical Trials 6/7/2019

    This poster reports a framework for the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors. Wearable technology is a key component in the design of more patient-centric clinical trials.

44. The Stakes Were High In This Phase II Study, But The Risk Was Under Control 4/17/2018

    Software solutions provider adds value for a midsize pharmaceutical company from a quality, cost and study governance perspective by enabling them to implement risk-based (dynamic) approaches to monitoring.

45. Achieving Clinical Operations Excellence 8/30/2017

    Learn how Revvity Signals Software 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.

46. 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.

47. 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.

48. 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.

49. 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.

50. 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.