Join us for Innovation Tour:

Preparing for 2021: COVID, Clinical, Regulatory and more

December 9th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

As we prepare to put 2020 behind us, our team of experts will look at some of the important changes this history year has brought to the Life Sciences industry.

This session will include a look forward to such topics as the changing regulations taking effect in 2021, the role of virtual inspections, the rise of remote monitoring, navigating this updates in a GDPR world, and the FDA's update on eCTD.

Innovation Tour Survey Results Panel: Future Trends in TMF, IDMP, and eCTD

October 29th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Throughout the Innovation Tour, participants have contributed their opinions to three survey topics: the eTMF Exchange Mechanism Standard, the IDMP Implementation Guide Version 1, and China's Readiness for eCTD.

The surveys are closed, and the results are in!

This session will take a deep dive into the results explore the future impact. 

Overcoming TMF Management Challenges Faced by Small and Mid-Sized Companies

October 14th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Maintaining an inspection-ready Trial Master File is becoming increasingly burdensome, even for teams with significant resources.

For small and mid-sized sponsors, however - with resources often stretched across managing the study as well as the Trial Master File – achieving ongoing TMF quality, completeness, and timeliness can be an overwhelming task. And while outsourcing some aspects of the TMF can help, that in turn creates its own set of challenges.

In this session, our experts will 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.

Taking a Risk-Based Approach to an Inspection-Ready Audit Trail

October 7th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

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.

We will cover the following topics:

• Understanding the requirements for audit trails
• How to look through all the actions and find what you are looking for
• Ways to follow your process and compare the audit trail
• How to document or show evidence of review

Solving the eMail Problem: Automating Correspondence Classification in the TMF

September 23rd, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Email correspondence represents one of the greatest challenges to building a complete Trial Master File.

This is a serious problem facing clinical trial sponsors, as it is difficult to capture all email correspondence and to classify it properly within the TMF.

In this session, we will discuss this problem from a compliance perspective and explore the TMF Reference Models correspondence guidance. 

The session will also feature a case study from Chiesi, discussing the problems they were facing and how a pilot study using Phlexglobal Artificial Intelligence helped with eMail classification. 

QbD: Should Operational Audit Readiness be Defined as ACA+C?

September 16th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). The ALCOA+C definition in ICH E6(R2) has created challenges and uncertainty within the industry with regard to its implementation in a TMF.

Fundamental to these new guidelines is the modernization of processes and technology to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices.

But, do “L” legible and “O” original, key components of the ALCOA+C guidance, and other quality attributes, prevent “C” contemporaneous in an operational TMF?

In this session we will explore:

• How a focus on an operational TMF will ensure QbD
• How contemporaneous can be defined in operational SOPs
• How contemporariness can be implemented in daily operations
• How to measure and document contemporariness
• Ensure audit readiness with regards to contemporariness

Panel Discussion: Innovative Approaches and Best Practices for TMF Management 

September 9th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Bringing together some of the best minds in Trial Master File management, this panel discussion will explore a variety of topics and ideas with a single focus: helping you achieve TMF Health.

Plus bring your ideas to this session for a chance to win points towards our Innovation Tour rewards!

The Journey from File to Trial: Automating Regulatory to TMF

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.

TMF Outsourcing
Fitting the Model to the Sponsor Model

August 19, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

There is no disputing the fact that Trial Master File Health is a vital part of drug development. And while there is no singular model for managing a TMF, it is also an undeniable fact that expert TMF support can plan an import role for any organization.

In this session, we explore the advantages and challenges of various TMF models such as CRO-led, Study Owners, Dedicated TMF Department and how outside, expert help can improve TMF Health in each situation.

Validating an AI Solution with a Focus on Clinical and Regulatory

August 12, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Artificial Intelligence is the future of technology. But how do you ensure that AI solutions will meet regulatory standards?

In this webinar our experts will review health authority recommendations (FDA, MHRA etc.) on validation of machine learning systems and discuss differences on validation methodologies for AI implementations. 

Most importantly, we will explore best practice validation techniques and walk through regulatory and clinical use cases of completed validation projects of data mining projects. 

New Approaches to Collaborative TMF Content Management

August 5, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Collaboration is key! Trial Master File management is never a solo project. It takes the right balance of people, process, and technology to ensure your TMF meets standards for timeliness, completeness, and quality.

In this session, two of the top minds in the business will share ideas on new ways to collaborate with TMF teams to better manage content. 

Trial to File to Trial + Archiving:

Innovative Approaches to meeting Archiving Requirements

July 22, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

It’s not uncommon for organizations to think it is enough to create an “archive” folder on a secure network to archive their electronic data generated from a drug development project.

However, this leaves your data and organization seriously exposed. 

In this session, Arkivum and Phlexglobal will demonstrate an exciting new approach to TMF archiving that not only meets requirements, but also creates value by bringing archived data to life.

Panel Discussion:

Innovation on IDMP / Data Preparation

July 15th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards - ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – designed to standardize the structure and terminology used to describe marketed medicinal products.

In this session, our panel of experts will discuss the innovative approaches they are taking to manage this 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.

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