Is your organization ready for IDMP? With the publication of the EU Implementation Guide v2.0 on February 22 2021, time is running out for companies with more than one or two marketing-authorized products in the EU to prepare effectively.
Download our free guide, “10 Key Steps to Help You Prepare for IDMP Compliance,” to benefit from Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.
In October 2020, the EMA guidance v2.7 for Veterinary Non-eCTD Electronic Submissions (VNeeS) came into force. As a result, animal health manufacturers will now be required to use an electronic format for all submission types.
To help prepare for this, Phlexglobal guide to VNeeS version 2.7, "3 Things to Know, and 5 Things You Can Do Today."
Discover insights from your peers and industry experts in this comprehensive analysis from Phlexglobal’s Innovation Tour – a journey through the world of clinical and regulatory innovation.
With a total of 1503 unique responses from our attendees, representing 401 unique companies in North America, Europe, the United Kingdom, and Asia, this white paper offers unique perspectives on how organizations are managing compliance for everything from the Trial Master File and eCTD, to GCP renovation and IDMP/SPOR.
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 management to a third-party provider. Based on Phlexglobal’s extensive experience encompassing TMF software, services, and compliance best practices, we have put together a pragmatic set of criteria to consider before you make this critical decision.
Learn how PhlexTMF+ provides all the components required for expert TMF management to ensure quality, completeness, and timeliness of your Trial Master File
Discover best practices on leveraging artificial intelligence to make regulatory compliance faster and more accurate, with less effort and cost.
You will also get valuable lessons learned from your peers, with real-world AI use cases that include:
With the EMA expected to be the first health agency to mandate compliance with ISO IDMP (with the FDA not far behind), organizations face a rapidly shortening timeframe to prepare for this the highly complex compliance mandate.
Download Phlexglobal’s latest executive brief, “New Developments in IDMP: What You Need to Know, and What You Can Do Today.” You’ll benefit from our extensive compliance and technology expertise in life sciences, as well as Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.
Becoming data-centric and mastering digital transformation is the most important topic for life sciences organizations of all sizes. However, Many companies have reached a plateau of digitalization and are not taking advantage of available automation technology. Download this infographic to learn what it means to be data-centric and the five things you should expect from Automation technology.
Download the executive brief, “Three eTMF Case Studies: Why CROs and AROs Are Choosing Phlexglobal” to learn why selecting Phlexglobal makes the most business sense, including:
Download the infographic “5 Reasons Why CROs Are Choosing Phlexglobal’s eTMF” to get learn why CROs and AROs are turning to Phlexglobal, such as:
Download the infographic, “How to Improve TMF Document Processing Speed and Quality” to learn why companies worldwide are relying on Phlexglobal’s leadership in TMF best practices to:
Download the infographic, “Improve TMF Management and Inspection-Readiness with PhlexTMF” to discover why sponsors and CROs worldwide have chosen Phlexglobal’s best-of-breed eTMF software to:
The guide is built on Phlexglobal’s years of experience conducting hundreds of successful migrations, for organizations ranging from small biotechs to the industry’s largest sponsors and CROs. Distilling our expertise across all types of migration scenarios as well as source and destination environments, the guide offers you core best practices that streamline TMF migrations while improving quality.
Based on helping companies pass hundreds of inspections by regulatory agencies worldwide, the guide will help you identify and correct those areas most often flagged by inspectors, including:
Learn how Phlexglobal helped a global biopharmaceutical company quickly turn a poor-quality Trial Master File into an inspection-ready asset through:
For over 20 years, Phlexglobal has helped organizations from Top 20 biopharmaceutical companies and the world’s largest CROs, to small biotechs and specialty CROs, achieve Trial Master File quality, completeness, and timeliness. Dedicated solely to TMF best practices in both software and services, we have a unique perspective on the core requirements to achieving ongoing TMF Health and inspection-readiness: what we refer to as the “TMF Health Zone.”
We have summarized this extensive knowledge into core principles, to provide pragmatic guidance on how to best reach the TMF Health Zone.
The European Medicines Agency (EMA) guidance on Trial Master Files took effect on June 6, 2019 and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.
Phlexglobal is offering this free guide by renowned TMF expert Eldin Rammell to help you better understand the impact this can have on your TMF management processes.
To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables.
This infographic outlines cues and actions, rewards, and routines for key positions relevant to TMF Health. To learn more about creating good TMF Habits, read our blog How to Transform TMF Quality Guidelines into Inspection-Readiness Habits or watch the on demand webinar featuring TMF expert Mark Webb.
