CluePoints, provider of risk-based monitoring (RBM) and data quality oversight solutions for clinical trials, has launched the “CluePoints RBM and ICH E6 (R2) Starter Pack” to help small and medium-sized enterprises (SMEs) achieve regulatory compliance through a risk-based approach
The starter pack, which includes both consultation services and software, has been developed following CluePoints’ extensive market and industry research to better understand the challenges faced by clinical development organisations and CROs since the introduction of the ICH E6 (R2) addendum.
The research undertaken by CluePoints highlighted the fact that many SMEs are unsure of how to embrace RBM and often how it might add significant value. The starter pack addresses this problem through the use of consultation on the ICH E6 addendum and RBM methodology.
The aim is to help organisations fundamentally understand what the regulation wants and demonstrate how a risk-based approach meets the compliance obligations and, at the same time, improves both cost and resource efficiencies.
The consultation also details the key software elements included in the starter pack. The software provides the necessary tools for organisations to start implementing a risk-based approach without overcomplicating the process, and gives users the freedom and opportunity to implement further RBM activities as and when required.
Included in the starter pack are a risk assessment (RACT) starter kit, key risk indicator starter kit, patient profiles starter kit, access to CluePoints proprietary signals and actions tracking management system and CluePoints central monitoring platform training.
“With the introduction of the ICH E6 (R2) addendum, the industry has seen an increase in the implementation of a variety of RBM methodologies and technologies. However, we found through extensive research that SMEs are more reluctant to adopt as they perceive these types of approaches to be expensive and complicated. Consequently, they are generally unsure of the steps they need to take to implement an RBM strategy, ” said Patrick Hughes, Chief Commercial Officer, CluePoints.
“As we see the industry change and evolve, the starter pack is a fit-for-purpose, affordable way for SMEs to learn how the regulations will impact them and to understand how an RBM approach can be implemented quickly and efficiently to suit their specific needs. This gives them a solution for ICH E6 compliance that will support them from pre-study risk assessment through to database lock and submission.”