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Operationalizing RBM – Free RBM webinar

(Expired) Successful risk-based monitoring extends well beyond just risk detection. The clinical R&D industry needs to deliver on the promise of quality improvement and cost reduction both operationally and from a regulatory perspective.  We must be able to show evidence that due planning and oversight has taken place during a study by building an audit trail of the way…

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OPRA – A practical RBM demonstration

(Expired) This webinar will give a brief summary of the concept and purpose of the OPRA RBM platform, followed by a detailed system demonstration of the features and functions. We will wrap up with an open question and answer session, where you will be able to address questions to TRI’s management team. Please follow the link below to register…

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OPRA – technology walk through and latest features

(Expired) Learn how OPRA has been designed to support the four pillars of RBM: Identify, Manage, Mitigate and Report. See the new features in the latest evolution of OPRA, and learn how TRI are continually improving the system in order to support any company wishing to benefit from quality oversight and risk-based monitoring. Who should attend: Existing customers of…

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Protocol Risk Assessment and Designing Site Quality Risk Indicators

(Expired) Within this webinar, we will: – Illustrate the process of using the outputs of protocol risk assessment to identify protocol risk indicators – Illustrate the process of designing protocol risk indicators – Explore the characteristics of good indicators of site quality risk – Explore the practical application of surrogate risk indicators in RBM

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Free Webinar – ICH GCP E6 Revision 2

(Expired) ICH GCP E6 revision 2 is due to be finalized this summer and implemented later this year. The impact on any company running clinical trials is going to be significant. Companies need to start planning now to ensure adequate time for change management and implementation to occur. This free webinar, focusing on quality management, will allow companies to quickly…

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TRI Position Paper – Designing Risk Metrics 22Oct2013

1. Background Triumph Research Intelligence (TRI) was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. Over the past 12 months TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as…

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OPRA Slide Presentations

Why? If a company wants to take a risk-based approach to monitoring, it must be able to prove it has a quality risk management plan which it executed, measured, and adjusted over time. How? TRI developed a purpose built application based on industry guidance that identifies site quality risk and allows central management of monitoring and risk mitigation activities What? OPRA…

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Protocol Risk Assessment Made Simple

(Expired) Protocol Risk Assessment – limited attendance Why is this webinar so important? Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and…

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Large Pharma RBM Implementation

Our client had strong ambitions to implement both risk-based monitoring (RBM) systems and processes across the entire global organization by the end of 2015. They had chosen a system to adapt to their needs and planned to work to the TransCelerate key risk indicators (KRIs). They needed support in developing the technology to meet their needs, needed guidance on…

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Free Webinar – 7th Feb 2017 – Using technology to support ICH E6 (R2) compliance

The video below shows TRI’s CIO Chad Finch introducing the webinar: This webinar is free to attend for anyone who is directly involved in the planning and execution of clinical trials.   WHO SHOULD ATTEND? Anyone who is already running clinical trials using the principles of quality management  as defined by ICH E6 (R2) and risk-based monitoring,  or anyone…

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EMA Announce Adoption Date for ICH E6 (R2)

As seen with ICH E6 (R1), the EMA have led the way, becoming the first to adopt. For convenience, we have added the adopted guidance document to our resources page: ICH E6 (R2) EMA Adopted Guidelines So, after a long year of discussion and delays in 2016, 2017 is going to be the year we really start to see…

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Central Monitor Job Description

The role of the central monitor On the 17th November 2016, the ICH Assembly reported that they had adopted the important amendment, ICH E6 (R2) that aims to encourage sponsor to implement improved oversight and management of clinical trials and that the amendment would now be implemented by ICH members through national and regional guidance.   (http://www.ich.org/ichnews/press-releases/view/article/ich-assembly-osaka-japan-november-2016.html). While we wait…

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Top 5 Challenges to ICH E6 Rev 2 Compliance

  Let’s look at the intent and purpose of the revision … The revised Addendum is proposed to modernize ICH E6 and enable implementation of innovative approaches to clinical trial design, conduct and management that will better ensure subject protection and data quality. This is a significant and positive step, but we will only realize the benefits if we…

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