Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Changes In Research: What Are They And When Do They Need To Be Submitted To The IRB?

  Changes in Research (CIRs) are one of the most common topics for inquiries that come to the Institutional Review Board (IRB). This post addresses two of the most frequent questions asked and general guidance around CIRs, discussing what should be considered a CIR and where there is flexibility in the processes and regulations to decrease the administrative burdens but maintain compliance.

• Ethical And Biosafety Oversight Of Gene Transfer Clinical Research: What Sponsors And CROs Need To Know

  This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States.

• Decentralized Trials For Duchenne Muscular Dystrophy

  Partnering with a global biotech, see how MRN was able to conduct 180+ monthly home visits to sustain trials for rare disease genetic medicine in vulnerable pediatric patients during COVID-19.

• 2021 Global MSP Benchmark Report

  This year’s report comes at a time when the world is still reeling from the impact of the COVID-19 pandemic. Although the MSP industry fared better compared to others, the big question is, has everything reverted to pre-COVID trends? Find out this and much more from our survey results.

• Understanding Iterative Direct DPD

  Digital pre-distortion (DPD) is a common method to linearize the output signal of a power amplifier (PA), which is being operated in its non-linear operating range. This article describes an approach to generate a pre-distorted signal based on a hard-clipper. The resulting waveform pushes the output of the DUT as close to the hard-clipper as possible.

• The Value Of Gene Therapy In Spinal Muscular Atrophy

  A client was developing a potentially curative gene therapy, they needed to translate the clinical benefit into economic terms to engage payers and health technology organizations. By working with the client to develop a cost-effectiveness and budget impact model for a gene therapy in SMA that overcame unique challenges of modeling an early childhood neuromuscular genetic disorder they were able to change the prevailing mindset on how SMA progression is characterized.

• Simplify And Streamline Study Builds

  “The whole build process is much faster and much easier for everyone involved.” With Vault EDC, discover how to streamline the study build process and reduce lead times for oncology trials.

• Small Town Realizes Big Savings With Prefabricated Lift Stations

  Discover how a small town added modern automation and controls to improve operations and minimize maintenance. 

• Markers And Methods To Verify Mesenchymal Stem Cell Identity, Potency, And Quality

  This white paper defines and discusses the evolution of MSC nomenclature and provides a detailed description of MSC markers and how they may vary by tissue source and species. Learn how to standardize MSC characterization by selecting markers for isolation, characterization, and validation.

• Method Optimization: Assay Development Following Compendial Methods

  There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

• A Five-Point Strategy For Building A CMC Dossier

  By adopting strategies to build a robust CMC package to help streamline the path to FIH trials, innovators can establish a quality foundation to support the development phases toward commercialization.

• The Paper Chase: Clinical Outcomes Assessments In The Digital Age

  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.