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Architecture of an Integrated Regulatory Information Management Platform for Clinical Trials: A Case Study in Regulatory Information Management System Implementation
Abstract
The pharmaceutical and medical manufacturing sectors have entered a period of disruptive transformation in the way regulatory affairs are conducted globally. The global clinical and regulatory landscape is evolving more quickly in this decade than ever before. The advent of adaptive trial designs, rolling submissions for indications, as well as the impact of regulatory policies in emerging markets, are influencing Pharma's ability to secure approvals efficiently and effectively and with required emphasis on safety and compliance. The impact of these changes on Regulatory Information Management can be significant over the next 5-7 years. Companies are rightfully asking what the transformation in business processes and technology might look like and what types of innovations they can adopt now to prepare them for the future state. The case study below introduces the need for an integrated Regulatory Information Management (RIM) platform, addressing key functionality of such an environment and describes the architecture & design consideration to industrialize such a platform.
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