IQVIA Global Compliance Releases 3 New Tools
IQVIA Global Compliance has released 3 new tools this week aimed at improving regulatory publishing cycle times and productivity: Regulatory Templates, Regulatory PDF Tools, and the eSubmission Validator.
- Regulatory Templates: These templates offer a fast, simple way to automatically generate regulatory documents. Users can choose from among 320+ regulatory shell templates through its menu-driven selection, as defined by US, EU, Swiss and Canadian regulatory agencies and the International Council on Harmonization (ICH) for both marketing and clinical trial applications. In addition, an add-in for Microsoft Office Word provides a focused toolbar with the best of Word formatting aids and a set of regulatory tools that ensure consistent tables, figures, headers and footers, plus configurable page layouts to fit your requirements.
- Regulatory PDF Tools (IRPT): Ninety to ninety-five percent of electronic regulatory submissions consist of PDF documents. IRPT provides authors a suite of about thirty fit-for-purpose “wizards” that improve cycle times and lower the effort required to prepare required PDF documents. Companies benefit from the speed resulting from IPRT’s built-in intelligence and highly intuitive user interface. This industry-standard toolkit assists publishers and reviewers in preparing, publishing and delivering compliant regulatory PDF documents – addressing specific regional regulatory agency and industry requirements.
- eSubmission Validator: The eSubmission Validator verifies that eCTD or NeeS submissions are in technical compliance with regional and ICH specifications and requirements prior to dispatch, thus avoiding costly delays due to refusal to file or rejection.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
