Professional Services

ICH E6 R2 compliance and RBM: Simple, efficient and tailored to your business

Every company is different, having it's own culture, capabilities and aspirations.
Yet all companies need to comply to the same guidance and regulations.

In order to serve our industry without becoming a commodity we have to be 'the same, but different'. To achieve this, TRI have developed a solution which can be applied quickly and consistently across organisations (we never re-invent the wheel) but at the same time can be tailored to deliver just what you need - nothing more and nothing less.

Taking this approach requires skilled, experienced staff, the ability to listen and a passion for customer success. Feedback from our ever growing list of customers is justification that we are doing the right thing!

Solution features

  • Online ICH E6 R2 awareness and certification courses 

  • Quality management capability maturity assessment

  • SOP / QMS gap analysis against the new ICH E6 R2 guidance

  • SOP / QMS updates and additions for alignment with ICH E6 R2

  • Training development and delivery for QMS awareness and compliance certification

  • Risk assessment approach and training

  • Risk detection and KRI / KPI design

  • Central monitoring and risk management guidance and support

  • Functional plan development

  • Quality management / RBM technology implementation

  • Study set up and ongoing support

Solution benefits

  •  Understand what ICH E6 R2 is and how it will impact your company – quickly and cost effectively

  • Understand the gaps in your quality management capability to enable the fastest route to compliance

  • Utilize our experience and IP to ensure your QMS meets the needs of ICH E6 R2 quickly and cost effectively

  • Ensure your organization is trained and certified quickly by through e-Learning or Webinar based training courses

  • Understand the concept of risk assessment and simple, pragmatic approaches, including the use of Transcelerate RACT and MCC RAMMT 

  • Learn how to design and utilize KRIs and KPIs for risk detection and quality management, using your own data sources

  • Put everything into practice with guidance and ongoing support in central and risk-based monitoring

  • Be inspection ready, with clear, relevant and well defined functional plans, and evidence of their usage

  • Benefit from the use of our OPRA quality management platform on a per study basis to:

    • Show evidence of your compliance with ICH E6 R2

    • Generate quality management reports for your CSR

    • Centralise risk assessment, risk detection, risk management and risk reproting

    • Gain efficiency and quality through  RBM