Patient Data Reporting Applications & Studies

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Flexible IRT Platform Solution For National Lung Cancer Trial 2/24/2021

    Trial design for a medicine trial to investigate treatment for non-small cell lung cancer presents unique challenges. These include the need for an IRT platform that can support the rapid incorporation of amendments and account for multiple or potential arms requiring different lists of material types and dosages that could be prescribed to patients and supplied to sites. Cenduit’s highly-configurable, flexible technology platform was the solution.

  9. Tekton Research Experiences A 'No Findings' FDA Inspection 2/5/2021

    As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

  10. From Liability To Asset: A TMF Rescue 1/28/2021

    The company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. During NDA preparations, they discovered that the Trial Master File for these studies was scattered across hundreds of boxes of paper and several hard drives. The document experts at Phlexglobal quickly scoped the project and were convinced they could deliver an inspection-ready TMF in the time allowed – which was fast running out.