Insights On Clinical Technologies

  1. 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.

  2. Exelixis Deploys InForm To Help Stabilize Their Clinical Study Process 6/1/2020

    This biotechnology company chose this solution to assist with user management and configuration with IRT. Looking ahead they hope to be able to expand its use including integrating with their safety system.

  3. Florence eTMF - An Intro To The Florence Electronic Trial Master File 11/3/2020

    Florence eTMF is designed to give you all the capabilities you need in an intuitive and flexible interface. Plus, you get remote digital connection to 7,200 research sites managing their eISF on our network, with the ability to deploy the #1 digital site workspace to all of your study sites.

  4. The Paper Chase: Clinical Outcomes Assessments In The Digital Age 2/11/2021

    Patient data are collected via clinical outcomes assessment (COA) tools that can be either paper-based or electronic, with the latter in the form of voice response systems, web portals, specialized handheld devices, and smartphones. Here, we’ll review the pros and cons of the different modalities and offer our perspective on the future of COA tools.

  5. Integrating Complex And Disparate Laboratory Data In Your Clinical Trial 5/13/2020

    By adopting a method for seamlessly integrating and validating increasingly complex biomarker data, you can streamline your clinical trials, allowing life-saving drugs to reach the market – and patients – faster.

  6. 10 Things You Should Know About The New TMF Regulatory Guidance 1/28/2021

    The new European Medicines Agency (EMA) guidance on Trial Master Files forms the most detailed guide to TMF best practices yet published by a regulatory agency, and in fact is becoming a de facto industry standard. Based on Phlexglobal’s extensive experience helping organizations successfully pass hundreds of regulatory inspections, following are 10 key developments that you should be aware of.

  7. Remote Investigator Meetings: Another Piece Of The Virtual Trial Puzzle 7/20/2020

    One key milestone at the start of a study is the investigator meeting, where, in some cases, well over 100 professionals may gather from various locations. Since, as a community, we are actively in the process of exploring where we can and cannot go remote, investigator meetings are a perfect example of where there is great potential.

  8. From Industry Recommendations To Reality – What’s New In The TMF Reference Model 3.2.0 11/23/2020

    The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. This blog provides insights from a member of the sub-artifact working group tasked with the review for this new version.

  9. The Evolution Of Risk Management In Clinical Trials 6/17/2019

    The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality. Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.

  10. Preparation Is Key For A Successful eTMF Inspection 7/2/2019

    Receiving notification of an impending inspection can cause panic for TMF owners but, with the right preparation and tools, stress can be minimized.