Newsletter | February 18, 2021

02.18.21 -- Next-Generation A.I. In Clinical And Regulatory Solutions

Regulatory Robotic Process Automation: The Evolution From Compliance Enablement To Compliance Automation

During the last 20 years, IT systems and software, such as those used in regulatory, clinical, safety, and document management, have been implemented across life sciences organizations. While inconsistent in some areas, overall results have been impressive. These software-augmented processes have increased efficiency and productivity while improving patient safety and trial outcomes, and they have also helped reduce organizational risk in clinical development and regulatory compliance.

TMF Management Outsourcing Decision Guide: What To Know Before You Outsource Your Trial Master File

This guide is designed to help life science organizations make an informed decision around a complex question: whether to outsource some or all of their trial master file (TMF) management to a third-party provider. The questions and content in this guide provide a solid framework for discussion, and they outline the key requirements to look for in a provider.

AI-Powered Automation Proven In Life Sciences

This article explores how AI is helping life sciences organizations increase speed and accuracy while freeing knowledge workers from time-consuming manual tasks. Data are the new gold, and AI-powered automation is seen as the critical tool to mine and manage that gold.

CRO Export? M&A Activities? Switching eTMFs? What You Need To Know About TMF Migrations

There are many sound reasons to migrate a trial master file (TMF), but doing so comes with a host of obstacles — ensuring data integrity and compliance, quality control (QC), managing legacy data, and dealing with data from different sources and systems, to name a few. This article provides a high-level view into some (but not all) of the obstacles you are likely to encounter.

The Journey From File To Trial: Automating Regulatory To TMF

This webinar explores 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.