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In this webinar, we will 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..
The Trial Master File, one of the most important elements of a clinical trial, can provide a useful tool for CRO oversight. Join us for this thought-provoking webinar as we explore ways to increase overall clinical trial quality.
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 explore the necessary steps to validate your system.
In this webinar, we will 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
On April 1st Phlexglobal presented a webinar on solutions to COVID-19 business continuity and fast track trial challenges. On May 7th we will hold an updated presentation covering new information on this vital topic.
Who should watch: Clinical and Regulatory executives affected with business continuity issues and/or are working on COVID-19 trials
The TMF world has evolved from paper to file share to electronic... what is next? In this digital world it makes sense for TMF to follow the same path. In this presentation, Chief Strategy Officer Karen Roy will share her insights into the future of TMF technology.
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. While IDMP presents a challenge, forward-thinking organizations are looking at IDMP as an opportunity to dramatically improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.
The Covid-19 crisis has led to unprecedented changes in procedures and communications, impacting the ability of staff to focus on being productive while juggling competing demands. Companies are leveraging their teams’ ability to work from home, but this has its own disadvantages. Everyone is working under incredibly high stress loads and distractions.
During this webinar you will learn how to inspire corporate, departmental and individual compliance. We will examine how to create a culture of compliance and how to include inspection readiness into daily operations.
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As regulatory agencies continue to issue updated TMF guidance and tighten enforcement around the Trial Master File, we expect to see an increase in critical findings.
Join us to get practical tips on how to improve inspection-readiness in your organization – avoiding the most common mistakes organizations make regarding TMF quality, completeness, and timeliness.
COVID-19 presents a global challenge to our health and economic well-being. As pharmaceutical companies race to find a cure, they must still follow proper trial procedures to ensure patient safety and trial legitimacy. Additionally, government measures to control the spread are straining many companies resources, causing disruptions in normal documentation practices. Join Phlexglobal experts as they share their insights into ways to accelerate your COVID-19 studies and ensure business continuity for existing active trials
The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal.
As emphasis shifts towards process optimization, it may be only part of the solution. Point solutions can hinder the flow of data across the continuum, causing already entrenched silos to dig in further. To improve performance quality in study startup, two factors are needed: an end-to-end solution and support from top management.
Unfortunately, entrenched silos such as site identification, clinical development, data management, contracting and regulatory affairs have long stymied these data flow efforts because these departments often have minimal understanding of what is needed downstream.
Becoming data-centric and mastering digital transformation is the most important topic for life sciences organizations of all sizes. Many companies have reached a plateau of digitalization. While compliance is a key driver for technology investments, the ROI objectives, user adoption and process automation in many companies still have room for improvement.
Join us to find out how we are helping clients to master their digital agenda via proven AI solutions.
Contemporariness is not just isolated to the trial master file, it presents a problem to multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.
In an attempt to address the issue of contemporariness, sponsors and contract research organizations (CROs) have relied on resource-heavy and costly time-stamping of all incoming site correspondence to start the measure — but does this address regulatory concerns?
In this free webinar, the featured speakers will explore:
![Rules and Regulations [Converted]](https://www.phlexglobal.com/hs-fs/hubfs/Rules%20and%20Regulations%20%5BConverted%5D.png?width=3556&name=Rules%20and%20Regulations%20%5BConverted%5D.png "Rules and Regulations [Converted]")
Learn how to ensure you are complying to the regulations. With the EMA Guideline on the content, management and archiving of the TMF (paper and/or electronic) finally becoming official, join our webinar for a detailed assessment of the guidance.
TMF Migrations are an important component of many eTMF implementations. One of the biggest challenges facing the industry today is the rapid and accelerating shift from paper to electronic processes—with eTMF being a prime example.
Whether we like it or not inspections are a crucial part of clinical trials, and it is extremely important that all companies are ready and properly follow GCP guidelines. Being in a constant state of readiness allows companies to be organized and effective in advance of, during and after an audit. The challenge is to be “in control” of compliance while also balancing risk, quality and cost. The answer is to think pragmatically and get to the ‘just-right’ compliance level.
During this webinar you will learn how to inspire corporate, departmental and individual compliance. We will examine how to create a culture of compliance and how to include inspection readiness into daily operations.
