Join us for Innovation Tour 2021:

Innovation through Integration: Increase Speed without Compromising Quality

March 4th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

In this session, Oracle's Jim Streeter and Phlexglobal's Karen Roy will take a deep dive into the power that comes with an integration of "best-of-breed" products designed to unify data and overcome the legacy hurdles of clinical development

From Data to Information to Intelligence:

The Intelligent Operational Data Hub and the Future of Connected Technology

March 10th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

Traditional point-to-point technology integrations are challenging to build, expensive to maintain, and typically only offer an exchange of data. In comparison, An intelligent Operational Data Hub (ODH) offers an environment that connects a multitude of technologies and can infuse them with new value. This approach helps you where, when and for whom data needs to be mediated, shared, enriched and then linked. In this session, we will learn about the power of the Intelligent ODH and how Phlexglobal will use this technology to bring true intelligence to the life sciences industry

Streamlining TMF Documentation through Clinical Automation

March 31st, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

Maintaining a healthy TMF means properly filing documents in a timely manner. The answer to this challenge? Automation!

In this session, we will explore how AI technology can be used to implement the latest TMF best practices directly into the system so you can automate time-consuming manual processes.   

When RIM is not Enough: Overcoming the Limitations of Document-Driven Systems

April 7th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

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. 

IDMP Readiness: Updates and Best Practices

March 10th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards designed to standardize the structure and terminology used to describe marketed medicinal products.

Our experts will provide an update on the IDMP Implementation Guide, and a review of the substance, product, organisation and referential (SPOR) program 

Most importantly, the session will cover best practices being used by major Pharmaceutical companies to meet this important requirement. 

Reaching the TMF Health Zone 2021: The Power of A.I. and Mobile Technology

February 17th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality.

To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Zone” – requires experienced people trained on effective processes using the right technology.

In this session, updated for 2021, we will explore ways to reach this balance using new innovations like automated document indexing and mobile technology. 

Working with Your CRO's TMF: Part 1

January 27th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

Does your CRO manage your Trial Master File in its own system? There are many things to consider in this model to ensure a properly managed TMF. In Part 1 of this series, our TMF experts will cover the following topics:

• Setting up the TMF
• Ongoing management including the challenge of eMail Classification
• End of Study actions such as migrations and imports

From File to Trial to File: Benefits of an Integrated Clinical and Regulatory Perspective

January 20th, 2021

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.