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Resource Center TMF

WHITE PAPER

Best Practices for RIM Business Process Automation

 

 

 

 

READ

October 15, 2021

RIM/IDMP

WEBINAR

eTMF powered by AI: Automation Benefits and a Look at the Future

 

 

 

 

WATCH

October 13, 2021

TMF

CASE STUDY

How a Top 5 Pharmaceutical Company Improved Compliance Speed and Consistency with RIM Business Process Automation

READ

September 3, 2021

Automation, RIM/IDMP

WEBINAR

PhlexRIM 2.0: The First Regulatory Platform with Built-in Process Automation

 

 

 

WATCH

August 25, 2021

Automation, RIM/IDMP

WEBINAR

TMF Completeness: Simple Solutions for a Complex Problem

 

 

 

 

WATCH

August 11, 2021

TMF

CASE STUDY

How a Top 20 Pharmaceutical Company Leveraged Artificial Intelligence to Prepare for IDMP

 

 

READ

July 23, 2021

Automation, RIM/IDMP

WEBINAR

The Bridge Between Clinical & Regulatory: How CTR and CTIS are Revealing the Need for more Holistic Approaches

 

WATCH

July 14, 2021

Automation, RIM/IDMP

WEBINAR

Functional Work Streams: Operationally Preparing your Teams for Successful TMF Inspections 

 

 

WATCH

July 7, 2021

TMF, Outsourcing

ARTICLE

How Are Decentralized (Virtual) Trials Improving Clinical Efficiency?

 

 

 

 

READ

June 29, 2021

TMF

WEBINAR

The Vital Role of Trial Master Files in Mergers & Acquisitions

 

 

 

 

WATCH

June 29, 2021

TMF, Outsourcing

ARTICLE

How to Close the "TMF Compliance Gap" with Advanced eTMF Archiving

 

 

 

READ

June 14, 2021

TMF, Outsourcing

CUSTOMER STORY

Phlexglobal eTMF Customers See Double-Digit Time Savings and 95% Accuracy from Industry’s Most Advanced AI-Powered TMF AutomationREAD

June 2, 2021

Automation; TMF

WEBINAR

TMF Inspections: Being Prepared

 

 

 

 

 

WATCH

June 1, 2021

TMF, Outsourcing

ARTICLE

Overcoming TMF Artificial Intelligence Challenges

 

 

 

 

READ

May 30, 2021

Automation; TMF

CASE STUDY

Faster, Better, Easier: AI-Assisted Indexing Improves TMF Management

 

 

 

READ

May 30, 2021

Automation; TMF

WEBINAR

IDMP Readiness: Updates and Best Practices

 

 

 

 

WATCH

May 5, 2021

RIM/IDMP

WEBINAR

Crossing the TMF Compliance Gap with Inspection-Ready Access for Closed Studies

 

 

 

WATCH

April 21, 2021

TMF, Outsourcing

ARTICLE

New Phlexglobal Solution Offers Easy TMF Inspection of Closed Studies, Addressing a Critical Compliance Gap in the TMF Lifecycle

 

READ

April 13, 2021

TMF, Outsourcing

CUSTOMER STORY

5 of the Top 10 Global Pharma Companies Leveraging Phlexglobal's TMF Quality Review to Reduce Time, Cost, and Potential Risks from M&A Activity

READ

April 7, 2021

TMF, Outsourcing

WEBINAR

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

 

 

WATCH

April 7, 2021

RIM / IDMP

ARTICLE

TMF as a Part of the Bigger Records Management Picture

 

 

 

 

READ

April 3, 2021

TMF, Outsourcing

WEBINAR

Streamlining TMF Documentation through Clinical Automation

 

 

 

 

WATCH

March 31, 2021

Automation; TMF

CUSTOMER STORY

Treximo Selects Phlexglobal's Innovative Submission Software as Technology Foundation Supporting Strategic Growth in Regulatory Services

READ

March 25, 2021

eCTD

WEBINAR

From Data to Information to Intelligence: The Intelligent Operational Data Hub and the Future of Connected Technology

WATCH

March 10, 2021

Automation

WEBINAR

Innovation through Integration: Increase Speed without Compromising Quality

 

 

 

WATCH

March 3, 2021

TMF, Outsourcing

WHITE PAPER

10 Key Steps to Help you Prepare for IDMP Compliance

 

 

 

 

READ

February 24, 2021

RIM / IDMP, Outsourcing

WEBINAR

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

 

 

 

WATCH

February 17, 2021

TMF, Outsourcing

ARTICLE

How to Ensure Your Trial Master File's Audit Trail is Inspection-Ready

 

 

 

 

READ

February 8, 2021

TMF, Outsourcing

WEBINAR

Working with Your CRO's TMF: Part 1

 

 

 

 

 

WATCH

February 8, 2021

TMF, Outsourcing

WEBINAR

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

 

 

 

WATCH

January 20, 2021

eCTD; TMF; RIM/IDMP

ARTICLE

AI Advances in Life Sciences Regulatory: 2020 Review and 2021 Expectations

 

 

 

READ

December 15, 2020

Automation

CUSTOMER STORY

Hope Biosciences Stem Cell Research Foundation Selects Phlexglobal to Support Rapid, Compliant New Drug Application for COVID-19 Therapy

READ

November 20, 2020

eCTD

PRESS RELEASE

Version 3.2.0 of the TMF Reference Model Launched

 

 

 

 

READ

November 2, 2020

TMF

WHITE PAPER

Industry Survey Results & Expert Analysis

 

 

 

 

 

READ

October 29, 2020

eCTD; TMF; RIM/IDMP, Automation

WEBINAR

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

 

 

 

WATCH

October 29, 2020

eCTD; TMF; RIM/IDMP, Automation

WEBINAR

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

 

 

 

WATCH

October 14, 2020

TMF, Outsourcing

WEBINAR

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

 

 

 

WATCH

October 7, 2020

TMF, Outsourcing

CUSTOMER STORY

Phlexglobal Partners with PRA Health Sciences to Created Global TMF Center of Excellence

 

 

READ

September 23, 2020

TMF

WEBINAR

Solving the eMail Problem: Automating Correspondence Classification in the TMF

 

 

 

WATCH

September 23, 2020

Automation, TMF

ARTICLE

Achieving and Maintaining Sponsor Oversight of Outsourced Studies

 

 

 

READ

September 17, 2020

TMF, Outsourcing

WEBINAR

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

 

 

 

 

WATCH

September 16, 2020

TMF

WEBINAR

Panel Discussion: Innovative Approaches and Best Practices for TMF Management

 

 

 

WATCH

September 9, 2020

TMF, Outsourcing

ARTICLE

Innovations In IDMP Preparation: Perspectives from Sponsors

 

 

 

READ

September 8, 2020

RIM/IDMP

WEBINAR

The Journey from File to Trial: Automating Regulatory to TMF

 

 

 

 

WATCH

August 26, 2020

Automation, TMF, RIM/IDMP

CUSTOMER STORY

Phlexglobal Supports Synairgen’s COVID-19 Clinical Trial with Implementation of Advanced eTMF Solution in Just 16 Days

 

READ

August 19, 2020

TMF

WEBINAR

TMF Outsourcing: Fitting the Model to the Sponsor Model

 

 

 

 

WATCH

August 19, 2020

TMF; Outsourcing

WEBINAR

Validating an AI Solution with a Focus on Clinical and Regulatory

 

 

 

 

WATCH

August 12, 2020

Automation, TMF; RIM/IDMP

ARTICLE

TMF Risk-Based Quality Control: What Does this Really Mean?

 

 

 

 

READ

August 11, 2020

TMF, Outsourcing

WEBINAR

New Approaches to Collaborative TMF Content Management

 

 

 

 

WATCH

August 5, 2020

TMF, Outsourcing

WEBINAR

Trial to File to Trial + Archiving: Innovative Approaches to meeting Archiving Requirements

 

 

 

WATCH

July 22, 2020

TMF; RIM/IDMP; Outsourcing

INFOGRAPHIC

Simplify Compliance While Delivering Ongoing TMF Health

 

 

 

 

VIEW

July 16, 2020

TMF, Outsourcing

WEBINAR

Innovation on IDMP / Data Preparation

 

 

 

 

 

WATCH

July 15, 2020

RIM/IDMP

WHITE PAPER

TMF Management Outsourcing Decision Guide

 

 

 

 

READ

July 14, 2020

TMF, Outsourcing

PRESS RELEASE

Phlexglobal Providing Vital Support for COVID-19 Clinical Trials

 

 

 

 

READ

June 2, 2020

TMF; Outsourcing; RIM/IDMP

WEBINAR

How Digital Disruption Is Shaping TMF Technology to Drive TMF Health

 

 

 

WATCH

May 13, 2020

TMF; Automation

WEBINAR

Leveraging your TMF as an Oversight Tool

 

 

 

 

 

WATCH

May 10, 2020

TMF, Outsourcing

WEBINAR

New Insights into COVID-19 Drug Development

 

 

 

 

WATCH

May 5, 2020

TMF; RIM/IDMP

ARTICLE

Updated FDA Guidance on Clinical Trial Conduct During COVID-19

 

 

 

 

READ

May 5, 2020

TMF; RIM/IDMP

EXECUTIVE BRIEF

Regulatory Robotic Process Automation: The Evolution from Compliance Enablement to Compliance Automation

 

READ

May 4, 2020

Automation;  RIM/IDMP

WEBINAR

Leveraging Automation for IDMP Readiness

 

 

 

 

 

WATCH

April 29, 2020

Automation, RIM/IDMP

WEBINAR

Using Habits to Counter COVID-19 Stress and Support TMF Health

 

 

 

 

WATCH

April 23, 2020

TMF

ARTICLE

AI Powered Automation Proven in Life Sciences

 

 

 

 

 

READ

April 20, 2020

Automation; TMF, RIM/IDMP; IDMP

WEBINAR

TMF Trend Analysis: Top 5 Inspection-Readiness Mistakes (and how to fix them)

 

 

 

WATCH

April 7, 2020

TMF; Outsourcing

WEBINAR

Solutions to COVID-19 Business Continuity and Fast Track Trial Challenges – Clinical and Regulatory Aspects

 

 

WATCH

April 1, 2020

TMF; Outsourcing; RIM/IDMP

INFOGRAPHIC

Digitalization and Automation in Life Sciences

 

 

 

 

VIEW

March 26, 2020

Automation

WEBINAR

How Automation is Transforming Regulatory Compliance in Life Sciences

 

 

 

WATCH

March 25, 2020

Automation, RIM/IDMP

ARTICLE

10 Ways to Beat COVID-19 Stress

 

 

 

 

 

READ

March 25, 2020

Outsourcing

CASE STUDY

Three eTMF Case Studies: Why CROs and AROs Are Choosing Phlexglobal

 

 

 

READ

March 16, 2020

TMF, Outsourcing

INFOGRAPHIC

Reduce Risk and Improve Inspection-readiness with Expert TMF Document Processing

 

 

VIEW

December 16, 2019

TMF, Outsourcing

INFOGRAPHIC

5 Reasons Why CROs are Choosing Phlexglobal to Build a Successful eTMF Practice

 

 

 

VIEW

December 12, 2019

TMF, Outsourcing

ARTICLE

Prepare yourself for 2020 – Global regulatory update

 

 

 

 

READ

December 6, 2019

eCTD, RIM/IDMP

ARTICLE

Common Promotional Submissions in eCTD Errors and How to Avoid Them

 

 

 

READ

November 20, 2019

eCTD

ARTICLE

Highlights from the 2019 US TMF World Forum

 

 

 

 

 

READ

November 11, 2019

TMF

PARTNER STORY

Oracle Health Sciences and Phlexglobal Collaborate to Reduce Operational Bottlenecks in Clinical Research

 

 

READ

October 23, 2019

TMF

WHITE PAPER

From Chaos to Order: Your Expert Guide to TMF Migration Planning

 

 

 

 

READ

September 17, 2019

TMF, Outsourcing

ARTICLE

5 Reasons your TMF Isn't Inspection-Ready (and what you can do to fix it.)

 

 

 

READ

August 15, 2019

TMF, Outsourcing

CASE STUDY

From Liability to Asset: A Trial Master File Rescue

 

 

 

 

 

READ

July 24, 2019

TMF, Outsourcing

WHITE PAPER

Reaching the TMF Health Zone: Expert Guidance from the TMF Authority

 

 

 

READ

July 2, 2019

TMF, Outsourcing

ARTICLE

What To Know Before You Migrate a Trial Master File

 

 

 

 

READ

June 30, 2019

TMF, Outsourcing

WHITE PAPER

10 Things You Should Know About The New TMF Regulatory Guidance

 

 

 

READ

June 19, 2019

TMF

ARTICLE

EMA’s Trial Master File Guidance is in Effect. Are You Ready?

 

 

 

 

READ

June 13, 2019

TMF

ARTICLE

Health Canada revises validation rules for eCTD format

 

 

 

 

READ

May 28, 2019

eCTD

ARTICLE

How to Transform TMF Quality Guidelines into Inspection-Readiness Habits

 

 

 

READ

May 1, 2019

TMF, Outsourcing

INFOGRAPHIC

Recommended Trial Master File Habits by Role

 

 

 

 

VIEW

May 1, 2019

TMF, Outsourcing

WEBINAR

What Rules and Regulations are doing to TMF Management

 

 

 

 

WATCH

April 16, 2019

TMF

ARTICLE

10 Short Years Ago, the TMF Reference Model Was Born

 

 

 

 

READ

April 3, 2019

TMF

ARTICLE

FDA at DIA RSIDM 2019 – Presentations Highlights

 

 

 

 

 

READ

February 18, 2019

IDMP/RIM

WEBINAR

Managing TMF Migrations

 

 

 

 

 

WATCH

February 13, 2019

TMF, Outsourcing

WEBINAR

Transforming Guidelines for TMF Quality into Inspection Readiness Habits

 

 

 

WATCH

January 15, 2019

TMF, Outsourcing

ARTICLE

Phlexglobal’s View on eCTD v4.0

 

 

 

 

 

READ

October 30, 2018

eCTD

ARTICLE

Health informatics – IDMP – Implementation guidelines for ISO 11238

 

 

 

 

READ

August 28, 2018

IDMP

ARTICLE

Australian regional specification – eCTD Version 3.1

 

 

 

 

READ

June 14, 2018

eCTD

ARTICLE

SPOR Update 2018 – News from the EMA webinar

 

 

 

 

READ

March 15, 2018

RIM/IDMP

ARTICLE

eCTD Health Canada – an Overview

 

 

 

 

 

READ

November 28, 2017

eCTD

ARTICLE

eCTD Brief: The Deep Dive into Electronic Submissions

 

 

 

 

READ

November 1, 2017

eCTD

ARTICLE

Data Mining as the First Touch Point with AI

 

 

 

 

 

READ

October 19, 2017

Automation

ARTICLE

FDA has published a new guidance on eCTD 4.0

 

 

 

 

READ

October 5, 2017

eCTD

ARTICLE

ICH’s Value to Regulatory

 

 

 

 

 

READ

August 11, 2017

eCTD

ARTICLE

The Challenge with EMA’s Changing Timelines for IDMP

 

 

 

 

READ

July 18, 2017

RIM/IDMP

ARTICLE

Regulatory Information Management – traditional vs. modern

 

 

 

 

READ

June 15, 2015

IDMP/RIM

ARTICLE

eCTD in the Cloud – Risk-Benefit Analysis

 

 

 

 

 

READ

February 24, 2015

eCTD

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