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Resources

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve…

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ICH E6 R2 Breakdown by Section

This ICH GCP Guideline Integrated Addendum Breakdown provides a quick overview of the unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the…

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Senior Technical Business Analyst (Greater London Based)

Are you looking for a new challenge? We are seeking a Senior Business Analyst for client requirements gathering and project documentation with the company Project Manager and Development team; thoroughly map and measure business workflow/process; document interactions between people, process and technology; collaborate with clients and internal partners; quantify business process capacity, capability and potential savings with improvement recommending…

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Life Science Solution Sales Manager (U.S. – East Coast Based)

We are currently looking for a SSM responsible for generating new sales for our Life Sciences portfolio which consists of: Training, Consulting and Technology for Quality Management and Risk Based Monitoring within the Clinical Trial Life Sciences industry. You would sell to clinical quality assurance, managers, directors and C-level associates from Pharma, CRO, Medical Device and Biotech firms located…

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Datatrial and TRI announce tech tie up

Datatrial and TRI announce tech tie up The clinical trials industry is going through the biggest regulatory change in two decades, forcing companies that run trials to adopt a data driven approach and focus more on quality risk management. Dr Emma Banks, CEO of Datatrial based in northeast England said: “We are delighted to announce Datatrial’s technology partnership with TRI. We…

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Web Application Developer (Greater London Based)

Triumph Research Intelligence (www.tritrials.com), a subsidiary of Triumph Consultancy Services (www.triumphconsultancy.com), is looking for energetic web application developers that want to apply knowledge and experience to the creation of a leading edge web application for the clinical trials industry. Our product, OPRA, is growing and to keep up with the demand we need to expand our team. If you…

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Advance Clinical RBM Implementation

Our client, Advanced Clinical a successful, forward looking CRO who were seeing increasing demand from sponsors to offer quality oversight and central monitoring in accordance with the incoming ICH E6 (R2) guidance. Advanced Clinical wanted to ensure they had both the processes and technology needed to be able to offer and articulate this capability as part of any future…

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TRI to attend North East England Life Science Showcase – Boston, Nov 30

North East England is hosting a morning of networking, presentations and discussion alongside pharmaceutical and biotech businesses based in Boston. DATE AND TIME: Thu 30 November 2017, 08:30 – 15:00 EST LOCATION: Boston Marriott Cambridge, 50 Broadway, Cambridge, MA 02142 Program includes: 8:30am Networking and refreshments 9:00am Welcome and introduction 9:15am Company showcase and industrial insights In vitro pre-clinical…

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TRI nominated for the 2016 Metrics Champion Consortium(MCC) Champion award

TRI has been selected as a member of this year’s group of MCC Champions – a special honor bestowed upon individuals who made significant contributions in 2016 to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. As the Metrics Champion Consortium (MCC) passes its ten year anniversary, the original mission has stayed the…

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The maturing of RBM implementation

As we at TRI continue to engage with industry on RBM implementation, I am pleased with the observations that we are currently making across a range of CRO and Pharma companies. Rolling back the clock 18-24 months and most of the discussions we were having with customers and prospects were about risk detection, data visualisation and stats models. For…

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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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