ABOUT PHLEXGLOBAL

Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organizations to a new level of effectiveness. PhlexTMF, the company’s Trial Master File software, and Regulatory Solutions including PhlexSubmission for eCTD and CTD, PhlexIDMP, PhlexEVMPD, and PhlexRIM are considered highly innovative in the industry for their out-of-the-box best practices capabilities, use of automation technology, and user-focused design. PhlexDistiller, a machine learning platform that reads documents and converts unstructured content into structured data, achieves automation of regulatory and clinical processes and completes the end to end solutions offering from Phlexglobal.

WEBINARS

In this session, two of the top technology minds in TMF management will demonstrate and a simple yet innovative way to measure completeness at any point during the trial. 

In this webinar, Phlexglobal Regulatory experts demonstrate how PhlexRIM will help you work faster and smarter, by streamlining business processes to provide a single source of global registration information.

Inspection readiness is all about preparation. Not just having your documents in order, but also your team. In this session, seasoned TMF expert McKenzie Knudson will share a proven approach to getting your team ready for inspections.

Explore the next stage of regulatory information management. It's time to move past electronic versions of old paper-based processes and see the efficiency that comes with a data-focused approach.

Your drug study is closed, you need inspection-ready access to the Trial Master File, but your CRO is ready to get the TMF out of their system and wants to send you a zip folder full of documents. What do you do? In this session, we explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents. 

Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

Maintaining an inspection-ready Trial Master File is becoming increasingly burdensome, even for teams with significant resources. In this webinar our experts walk through a new, full-service TMF management approach implemented by smaller biopharmaceutical companies. By adopting a fixed-fee, turnkey model encompassing everything required for ongoing TMF health, these organizations are achieving high-quality TMF compliance – with far less effort.

In this webinar, we explore 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.

In this webinar, our panel of experts will discuss the innovative approaches they are taking to manage IDMP, a vital part of pharmaceutical commercialization. Topics will include ways to improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.