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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
