Patient Data Reporting Applications & Studies

  1. 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.

  2. 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.

  3. 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.

  4. Three eTMF Case Studies: Why CROs And AROs Are Choosing Phlexglobal 1/27/2021

    Learn why leading contract and academic research organizations – from the world’s largest CROs and AROs, to mid-sized and specialty organizations – are selecting us as their eTMF partner following comprehensive vendor assessments.

  5. eRegulatory: A Site's Perspective 9/28/2020

    Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

  6. Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program 8/19/2020

    A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.

  7. Texas Cardiology Research Department Transforms Document Access, Fuels Productivity 6/24/2020

    What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

  8. Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS 3/6/2020

    Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.

  9. Evidence Generation Strategic Partnership For Heart Failure Studies 12/9/2019

    Read how a pharmaceutical support services company helped a large pharmaceutical company manage a portfolio of 5 heart failure studies, with over 500 investigator sites and 7,000 patients, to accompany an evidence generation program for a new product launch.

  10. Data Standardization For Late Stage Development And Periapproval Studies 7/10/2019

    Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.