Enterprise IT

Sales Efficiency in the Digital Era

The sales process will always boil down to people selling to people. In the digital era, with emerging innovations in machine learning and artificial intelligence (AI), the human element in sales is rapidly evolving, leaving behind personal limitations…

Enterprise IT

Qualifying Clinical Site Personnel Using Embedded Automation

As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Given that clinical trials in Asia had experienced 30% average annual growth from 2005 to 2012, travel takes up a much greater portion of the study management team’s time and energy. That’s why study teams have turned to technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and postmarketing studies.

To be successful, site personnel qualification technology must be targeted to each role within the clinical research site. Otherwise, each individual within the site would receive too much or not the right material that pertains to their function within the study. As a provider of clinical site qualification technologies to the Life Sciences industry, UL Compliance to Performance has identified four guiding rules for structuring an automated Clinical Qualification solution within a company’s clinical system architecture.

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Enterprise IT

MasterControl Registrations for eCTD

While the information required is essentially the same for various registrations as many countries have adopted the Electronic Common Technical Document (eCTD) standard, the preparation, presentation, and the depth of information submitted vary greatly…

Enterprise IT

Convergence of Compliance & Technology

We live in a time of rapid change and information overload. It helps to pause and ponder the state of things once in a while. In the software industry, the Agile principles call for regular evaluation to sustain constant development work. In the quality field, the concept of continuous improvement is embedded in the Quality Management System (QMS) as a never-ending cycle of changes based on reviews and audits.

This book will explore how the use of technology in the past decade or so has helped both regulated companies and regulatory agencies in easing the pains of delivering those products to patients and consumers worldwide. Regulatory milestones enforced by the FDA helped define the book’s scope.

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Enterprise IT

Convergence of Compliance & Technology

We live in a time of rapid change and information overload. It helps to pause and ponder the state of things once in a while. In the software industry, the Agile principles call for regular evaluation to sustain constant development work. In the quality field, the concept of continuous improvement is embedded in the Quality Management System (QMS) as a never-ending cycle of changes based on reviews and audits.

This book will explore how the use of technology in the past decade or so has helped both regulated companies and regulatory agencies in easing the pains of delivering those products to patients and consumers worldwide. Regulatory milestones enforced by the FDA helped define the book’s scope.

Request Free!