Patient Data Reporting Applications & Studies

81. Accelerating Database Lock: Adaptive Design & Remote Monitoring 8/17/2021

    Reach database lock in less than one month instead of a year. That’s what one large pharmaceutical company achieved by providing real-time remote access to validated clinical data.

82. Using De-Identified Linked Real-World Data To Create An External Control Arm 7/13/2021

    A pharmaceutical company designed its Phase II study of a novel agent to treat metastatic non-small cell lung cancer driven by a rare subtype of EGFR genetic mutation. They needed to construct a control arm that had cohort of patients with the specific subtype of metastatic EGFR non-small cell lung cancer whose disease progressed despite taking platinum-based chemotherapy. By utilizing a platform that allowed them to collect data across three vendors that represented unique patients proved successful and enabled the company to move forwards with the Phase II pivotal trial.

83. Virtual Study Yields High Compliance & Retention Rates 6/21/2021

    Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

84. Retention And Compliance In A Multicenter, Open-Label Clinical Trial 6/18/2021

    Missing outcome data caused by patient dropout and poor compliance not only jeopardize the scientific validity of a study, but also come at a significant financial cost to study sponsors. Technology and behavioral science offer potential solutions that together can address these challenges through patient-centric design of tools. This case study examines retention and compliance in a multicenter, open-label clinical trial (N=36) with the use of the Linkt mobile application.

85. Teens Give Thumbs Up To Electronic Diabetes Assessments 6/16/2021

    In order to ensure a fluid experience for a patient, usability testing is a critical data point to consider. Addressing both a patient’s needs and access to a digital platform is key to data collection. TransPerfect, along with our partners from Parexel, Clinical Ink, and Health Psychology Research, recently published a poster at the Virtual ISPOR Europe 2020 conference that reviews the impact of moving from in-person to electronic data collection.

86. AI-Assisted Indexing Improves TMF Management 5/24/2021

    The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. In this case study, learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while maintaining 98% accuracy.

87. Accurately Aligning Data Structures That Can Stand Up To Regulatory Scrutiny 4/7/2021

    A biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As the team started to plan their first Phase I study they realized that they wanted to align the data structures from both studies. By applying previous experience of rescue approaches for clinical data, Cmed built an encapsia database to meet needs for all prospective data.

88. Automatic Score-Based Treatment Path For Site Users 4/7/2021

    A biopharmaceutical company had a Phase II study with 300 patients in 5 countries. At a key point in the study each patient’s treatment path depended on a score calculated from data collected over the previous period. Cmed was able to provide them with a solution that would enforce a workflow to ensure the accuracy of the data used in the score calculation.

89. 4 Machine Learning Use Cases for Clinical Trials 2/25/2021

    Want to optimize your clinical documentation processes, promote effective TMF automation, and improve the overall process efficiency with machine learning (ML) technologies? Here are four business cases where ML can help you approach TMF documentation processes with greater efficiency, timeliness, and quality.

90. Pharma Sponsor Enlists Cenduit IRT To Rescue A Multi-Country, Multi-Site Oncology Study 2/24/2021

    After go-live, the sponsor learned its study did not fit the existing IRT solution, affecting data quality, timelines, and drug supply shipments. The legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design. Read how Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.