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

The “Clinical Trials and TMF 101 Learning Series” kicks off it’s second session with three industry experts, that goes through some of the basics of clinical trials.

Spark a deeper and broader understanding of the world of Drug Development, Clinical Trials, Regulations, the Trial Master File, and much more – for the industry novice as well as the guru.

As requirements for improved inspection-readiness and quality risk management become more critical than ever, discover the need to create seamless integration and data flow between the eTMF and CTMS in a study.  

Watch this panel of regulatory experts taking part in an interactive roundtable examining the benefits of establishing standard terminology and its potential to help significantly improve regulatory quality, data accuracy, and efficiency.

Are you looking for an easy to use and intelligent Regulatory Information Management solution? Work faster and smarter, by streamlining business processes to provide a single source of global registration information – join the PhlexRIM 2.1 session with regulatory experts Jim Nichols and Aaron Grant.

The TMF Reference Model is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands? Watch the “Ask An Expert” session on demand with the co-founders of the TMF Reference Model Karen Roy and Lisa Mulcahy.

For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. View our experts explore what your TMF Health Score could be and how this can be used to achieve and maintain ongoing TMF health and inspection readiness.

The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?

Concerned about inspection readiness & compliance of your TMF for a recently acquired product? The toughest TMF challenges were brought to this open forum, where Karen Roy, TMF Reference Model co-founder and, Sarah Tucker answered your questions and provided expert TMF guidance. 

2022 will be an important year for drug development. There are many questions around changes that came into play during the pandemic. A panel of experts look back over the year and into the future to help you prepare for the coming year.

Watch the available webinar to find out solutions for how to continue to refine and improve eTMF’s ability to automatically classify documents.

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.