+44 (0)20 8817 5296info@tritrials.com

ICH E6 Revision 2 Approved

First new regulatory Members of ICH, key global good clinical practice guideline revisions agreed The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug…

Read More

Setting Your Own Standards for ICH E6 Rev 2 Implementation

  The “eagerly awaited” revision to ICH E6 is going to provide a clear message about the expectation for how a clinical trial is conducted in today’s world compared to the world of the mid 1990’s when the first version was adopted by the three ICH regions. ICH E6 is by definition a guideline and therefore provides guidance, i.e….

Read More

ICH E6 Revision 2 – What Does It Mean In Practical Terms?

Nowadays we all use multiple electronic systems in clinical trials. Consequently, we need SOPs in place to define/control how these are developed, used, accessed and secured to ensure of the integrity of the data we produce.   We’ve been doing corrective and preventive actions (CAPA) for years but Revision 2 emphasizes the need to analyse the “root-cause”…

Read More

ICH E6 Revision 2 – “Begin With The End In Mind”

  Regulators will soon require sponsors and CROs to demonstrate that they have effectively anticipated, managed and mitigated risk during the course of each study.   Identifying and then setting your end point as the target is the most likely way to achieve success.  We have to know where we want to end up in order to plan and…

Read More

Capability Maturity Model for Quality Management

What is a Capability Maturity Model? A capability maturity model (CMM) is a simple way to express an organisation’s capability in a defined area against a number of parameters. The traditional model offers five levels of maturity, typically defined as 1 – Initial, 2 – Managed, 3 – Defined, 4 – Managed, 5 – Optimized, as seen in the…

Read More

Industry Survey on ICH GCP E6 Rev 2 Readiness

Getting 67 companies to respond to a survey is no mean feat in itself, and whilst not a comprehensive measure of the current state of readiness, we feel it is a relevant enough sample size to be indicative of the industry in general. What do the results indicate? Firstly, it is encouraging that awareness levels seem to be really high, and…

Read More

What do you have in place for ICH E6 Rev 2, and what do you need?

How Can You Claim to Do Risk-Based Monitoring If You Don’t Know How Much Noise Is In Your System?   My last article was concerned with the overall lack of using available data and technology to make better decisions, which is endemic within industry as well as people’s personal lives. In fact, Conway’s Law would suggest that how individuals…

Read More

Better risk-based thinking will help produce better risk-based monitoring

How People Can Get Better At Risk-Based Thinking and Improve Their Organization’s RBM Misinformation about risk based monitoring abounds. In fact, the level of misinformation on the topic long ago surpassed the level of correct information. I wanted to provide some practical insight as to why risk-based monitoring is so important to the work you do. There is a…

Read More

Press Release – TRI become the first MCC Solution Provider

Following a long standing working relationship between Triumph Research Intelligence (TRI) and the Metrics Champion Consortium (MCC), TRI will now make the IP developed by the MCC’s Risk Management working group available as part of the risk assessment and management module in their OPRA platform. The need for a centralized, easy to use, auditable protocol risk assessment and management…

Read More

Press Release – Advanced Clinical selects TRI and OPRA for risk-based monitoring

Following a six month long industry wide technology assessment, Advanced Clinical, (Advanced) has selected Triumph Research Intelligence (TRI) as their RBM technology and services partner. TRI will be providing the OPRA platform for all of Advanced’s studies whose sponsors have requested a risk-based approach to monitoring with the objective of improving operational efficiency, quality, and patient safety. Conjointly, TRI…

Read More

Trial oversight in SMB Pharma – Reflections on 6th CQOF

Firstly, I wanted to say what a great event the CQOF was – well attended, well organised, great presentations and great dialogue. Well done Kristen and her team. There were a few more attendees than last year which is always positive, but a very different demographic and feel to the event. The focus on the relationship between trial oversight…

Read More

European Clinical Insights Press Release

TRI were delighted to take part in such a valuable set of meetings and have just been quoted in OmniComm’s recent press release regarding the event. TRI pride themselves on supporting the growth in uptake and understanding of risk-based monitoring within our industry and as such, events like these provide the perfect platform to understand the needs and challenges…

Read More

TRI complete second round of funding

Raleigh, NC, July 20th 2015 – TRI, the risk-based monitoring company, is very excited to announce the completion of their second round of funding, and the furthering of its partnership with Peter Brummitt and Bev Mehentee, co-founders of Wider Perspectives Ltd. TRI is enjoying ongoing and rapid growth thanks to strong market demand both for OPRA, the risk-based monitoring…

Read More