Insights On Clinical Technologies

1. Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts? 1/7/2020

   Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome data in clinical trials. This transition necessitated expensive and time-consuming mode equivalence testing. But now, the process of “expert screen review” is being considered as a more efficient and less expensive alternative.

2. The Next Generation Of Trial Master File Systems 11/20/2020

   The next generation of eTMF systems are coming into their own. They use Artificial Intelligence and Natural Language Processing (NPL) to improve efficiency, preserve one version of the truth, and maintain audit readiness. The following paper covers the current state of eTMF technology and the future level of functionality that users can now expect.

3. Getting Every Detail Right – With No Time To Think About How 2/21/2020

   With a customer racing to beat a competitor to registration with last patient out to database lock in two weeks, this CRO was able to step in and take charge and the study was completed on schedule.

4. Improve GI Data And Patient Engagement With GI ePRO/eCOA 2/10/2021

   Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) to improve data quality and integrity. Eligibility decisions based on data  derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. This paper describes the complexity of GI trials in detail and shows a solution that is designed to overcome their significant, but typical, challenges.

5. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

   In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.

6. PerkinElmer Solution For Clinical Study Data Review Used Across All Therapeutic Areas And All Phases Of Clinical Trials 1/22/2021

   Top 10 global biopharmaceutical company needed to implement a single clinical study data review system to reduce the time, cost and risk of running their clinical trials while accelerating the time to market. The company deployed PerkinElmer's interactive data visualization and analysis solution to their clinicians and safety reviewers as part of a safety review tool that is quickly becoming the tool of choice for clinical data review.

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. Correcting The Misconceptions Of ICH E6(R2) Compliance 6/11/2020

   Successful and compliant oversight in outsourced clinical trails requires sponsors to have access to data and the ability to act on the data and document actions. Read about the common misconceptions of ICH E6(R2) compliance and how you can correct them.

9. ICH GCP Update: Sponsor Control Of Clinical Trial Data 3/30/2020

   Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of ICH GCP provides new, more detailed guidelines for sponsors regarding the handling of clinical trial data, documents, and systems.

10. How To Eliminate Custom Functions From EDC 4/20/2021

    Learn how companies like ICON, Alcon, and Bioforum – The Data Masters are building edit checks directly within the EDC, eliminating the need for custom functions. With the powerful rules engine in Vault CDMS, these companies are speeding clinical trials and supporting greater agility during study conduct.