INSIGHTS ON CLINICAL TRIAL TECHNOLOGIES

• Preparation Is Key For A Successful eTMF Inspection

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

• How UAT Innovations Are Shaving Weeks Off EDC Builds

  Veeva and Vertex talk about the opportunity for process and technology innovations to reduce UAT timelines by over 50%.

• Actigraphy For Multiple Sclerosis

  Activity patterns of those with multiple sclerosis (MS) fluctuate over time according to exacerbations and remissions, and therefore represent an important marker of disease progression. Read how actigraphy can be used to to measure conventional activity, sleep, and circadian endpoints and more to assist in studies.

• 21 CFR Part 11 Compliance For Clinical Research Sites

  Understanding and following the detailed regulations around 21 CFR Part 11 requires a significant amount of time, resources and knowledge. We’re here to pass along to you as much of this information as possible so you can navigate with ease everything required for compliance – including validation, training and process development.

• Non-Compartmental Analysis And The Early Phase Regulatory Environment

  NCAs are an integral part of establishing an early phase audit trail, it is important to use NCA software that streamlines a detailed and complex workflow.

• Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF

  Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.

• Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC

  Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

• 2019 Market Research Report: The Use Of Virtual Components In Clinical Trials

  Some say that the use of digital technologies will enable remote patients to participate in these ‘virtual’ or ‘decentralized’ trials, where they haven’t been able to before. We hope this report will provide the foundation for an industry-wide effort to define what constitutes a decentralized clinical trial, and in turn help remove barriers to the effective use of patient-facing technologies and digital endpoints in the future.

• Lucky CRAs. Getting Automated To-Do Lists For Targeted SDV

  Data managers at Lotus Clinical Research used to spend hours each week building reports to identify the patients and forms that needed Source Data Verification (SDV) at the next site monitoring visit. To tackle the problem, Veeva Vault EDC introduced QuickView, a dynamic interface that optimizes the display of data by function, allowing users to focus on what matters most.