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.
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.
Join us as we examine how to create a culture of compliance and how to include inspection readiness into daily operations.
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.
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.
Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first “C” in the ALCOA-C guidance, but recent regulatory guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) has created new challenges and uncertainty within the industry with regard to its implementation in a trial master file.
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:
Join Generis, Lorenz, PhlexGlobal, DocShifter and Qdossier to learn how the Alliance of Experts provides Intelligent Regulatory Information Management (RIM) offered by an alliance of established experts. Hear how we approach this first and foremost from a process perspective to ensure we walk you through the complexities of the business requirements.
Join Generis, LORENZ and PhlexGlobal to learn how the Alliance of Experts provides Intelligent Regulatory Information Management (RIM) offered by established experts in regulatory information management, content management systems, and electronic Trial Master File (eTMF) systems and services.