Becoming Truly Digital, How Artificial Intelligence Is Transforming Compliance In Life Sciences




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Phlexglobal’s investments into cloud computing, innovative machine learning technology and automation, overlaying their leadership and expertise in both the Clinical and Regulatory spaces, will help the industry to master their path to digitalization.

Phlexglobal is known for its leading domain expertise in clinical and regulatory matters. It has led the Trial Master File (TMF) evolution, being the spearhead of the TMF Reference Model, an Industry standard for TMF structure – this model has transformed the way in which TMFs are managed globally. Through our innovation in artificial intelligence (AI), we have helped leading life sciences organizations dramatically reduce the time and manual effort involved with regulatory compliance, whether producing high-quality submissions for new marketed products, or effectively managing thousands of pages of Health Authority Correspondence.

As a result, Phlexglobal has emerged as a global leader encompassing compliance “from Trial to File™” – giving companies the innovative technology and services they need at every stage in the regulatory lifecycle, powered by deep and broad domain expertise.

As part of the digital evolution, the life sciences industry is experiencing a transfer from a document driven to a data driven process execution. This requires generating data, which in many cases is trapped in unstructured documents. It results in a new valuation of data. We, as Phlexglobal, via AI technologies such as Natural Language Processing (NLP), have developed text and data mining solutions that help the industry to automate this process.

What does this mean in practice: Phlexglobal’s automation technology within its TMF software, now is able to auto index study documents and generate data automatically, which before was required to be generated manually. Furthermore, the technology is able to read and interpret large email communication and can help reducing the quality control process significantly.

In the regulatory landscape data requirements for new compliance regulations such as IDMP (Identification of Medicinal Products) or eCTD (electronic Common Technical Document) have arisen. Extracting data from regulatory content to automate the drug approval or patient safety management process are areas for which Phlexglobal has developed innovative automation software.

Phlexglobal also aims to offer our customer its so-called “turbo charge” technologies to be plugged into its customer’s IT infrastructure. The aim is to support intelligent augmentation of existing IT landscapes rather than to replace it. In practice, this means that regardless of the eTMF, document management, or RIM system a customer has, Phlexglobal’s technology can be overlaid to support a customer’s processes across the Clinical and Regulatory landscape.

In summary, with this innovative approach of expert services combined with modern technology, Phlexglobal has facilitated a significant increase of process speed, cost savings and compliance automation and leads the way in the eTMF and Regulatory digital revolution.

Phlexglobal is the leading technology and services organization for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven Artificial Intelligence solutions.

Year Founded: 1998 Owned by: Vitruvian

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