As the adoption of Risk Based Monitoring (RBM) continues to grow across the clinical development industry, its impact is clear. RBM improves the quality, safety and efficiency of clinical trial management. While benefits are apparent, the industry is struggling to implement with confidence and gain the achievable benefits.

During this executive roundtable, Advanced Clinical and TRI will share the latest industry insights on what RBM means for your trials, practical guidance on how to implement and how to ensure compliance with ICH E6 (R2) when working with a CRO partner. The event will be run by a team of experts from Advanced Clinical and TRI and will be a great way to both accelerate your implementation of RBM and network with like-minded industry professionals.

Space is limited. Complimentary lunch will be served. Free parking is available.

Attend this event if you:

• Understand what RBM is, but are looking for a practical implementation approach

• Have started implementation, but are struggling to finish

• Have implemented RBM, and are now looking for tools and processes to maximize the value

• Are outsourcing your trials, and want to understand how RBM works under an outsourced model

• Want to share and learn with other RBM professionals
  
  

Speaker Biographies

Graham Belgrave, Senior Vice President, European Operations
Advanced Clinical
A graduate of Warwick University, Graham Belgrave has over 33 years of experience successfully leading pharmaceutical development across Clinical Operations (phases I-IV), Outsourcing & Contract Management, Project, Program and Vendor Management. After starting his career in clinical operations, Mr. Belgrave moved to senior management roles overseeing clinical operations and later outsourcing and vendor management functions for global top pharma and biotech companies. Most recently, he served as COO at a specialty mid-sized CRO headquartered in the UK. Mr. Belgrave is an active member and Honorary Fellow of the Institute of Clinical Research UK (ICR), a Fellow of the Royal Society of Medicine, a Chartered Scientist and a Member of the Institute of Biomedical Science as well as being an assessor for the Science Councils qualifications of CSci, RSci Tech and RSci.

Duncan Hall, CEO
TRI
Duncan has over fifteen years of consultancy experience, thirteen of which have been within clinical R&D in both CRO and Pharma businesses. Duncan started TRI in 2013 with the aim of building a global business which would be focused in improving the delivery, quality and value of clinical systems. Duncan now takes a primarily strategic role in TRI, but still performs client delivery roles for key clients.

Tammy Finnigan, COO
TRI
Tammy has 20 years clinical research experience, having worked in both large Pharma and large CRO companies prior to joining TRI. Her experience both in monitoring and managing clinical trials have provided valuable insight into the way quality management processes and supporting tools should work. Tammy is the business sponsor of TRIs RBM tool, OPRA and is actively involved in supporting multiple RBM projects with TRI clients. For almost 4 years, Tammy has been working with the MCC as a representative on the Risk Based Monitoring and Central Monitoring working groups.

About TRI

Triumph Research Intelligence (TRI) is a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials. It is based in Cambridge, UK, and Raleigh, North Carolina in the United States. Over 10% of failed NDA submissions are due to data quality and cost the industry hundreds of millions of dollars each year. TRI was founded in 2011 by CEO Duncan Hall to directly address this issue. TRIs products, solutions and services are designed to optimize clinical trial quality by improving data reliability and at the same time increase patient safety and operational efficiency.

About The Bradfield Centre

The event is organised in collaboration with The Bradfield Centre, Cambridge's hub for tech and deep tech companies. Our mission is to grow scaleups and provide them with the connections and support they need to thrive. The way we do this is by building a sense of community through human interactions and high-quality events which engage our members and allow for networking.