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Implementing Standards for the eClinical Vision

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Client Profiles

Assero have 10 years’ experience of delivering excellent results and project solutions to a variety of organisations involved in clinical research around the globe. The examples below encapsulate some of the work conducted during those 10 years. If you want to find out more or how we can help, contact us:

Top Ten Pharma

  • Metadata repository implementation working with the pharma company and their vendor to develop the model for the metadata repository based on the BRIDG model.
  • CDISC Standards implementation development and delivery including the development of ODM utilities to streamline the data flow between the pharma company and complex external data feeds.
  • Development and delivery of tailored XML training with hands-on practical expereince.
  • Development and delivery of ODM training tailored to the pharma companies specific use cases.

Midsized Pharma

  • Metadata repository consultancy providing advice and guidance on the use of metadata across the clinical trial process from protocol generation through to submission.
  • eClinical and standards implementation with supporting communications, education & governance consultancy.
  • eClinical consultancy providing advice on the use of CDISC standards to support the eClinical vision across the enterprise
  • Standards consultancy looking at specific implementation use-cases and developing standards-based solutions
  • Development of roadmaps for the implementation of CDISC standards

Vendors

  • Assero undertake the ODM certifications as part of the CDISC ODM Certification Program
  • ODM Compliance tools and test files
  • Assitance in the development of metadata repository tools

In addition, Assero has worked extensively with the regulatory authorities, standards development organisations and other relevant agencies for research.

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