Fast-Track Your ICH E6 (R2) Compliance and RBM Adoption

As a leading provider of Risk-Based Monitoring solutions, CluePoints recognizes the challenges faced by small and mid-sized research organizations in effectively adopting RBM and ensuring compliance with ICH E6 (R2).  Based on our experience to-date in helping many similar-sized companies to successfully overcome these challenges, we’ve developed a new offering, the CluePoints RBM Starter Pack, which leverages our existing, proven Intelligent Statistical Monitoring solutions and RBM expertise. This will enable your organization to adopt a risk-based approach that meets the compliance obligations of ICH E6 (R2) and benefit from the cost and resource efficiencies driven by Risk-Based Monitoring. Here’s what you can expect to get you started quickly and efficiently with a fit-for-purpose combination of technology and expert consultation:

ICH E6 (R2) and RBM Consultation

The RBM Starter Pack includes consultation that covers the following topics:

  • ICH E6 (R2) overview and an introduction to RBM methodology
  • Overview of the pre-study risk assessment & mitigation planning process, the TransCelerate RACT template, and a client-specific refinement of questions using the CluePoints RACT solution. Training will also be delivered on the CluePoints RACT tool, including a group exercise to conduct a risk assessment for a target study.
  • Key Risk Indicators (KRIs) – A review of their purpose, key considerations for optimal effectiveness, and a review of the standard KRIs proposed by CluePoints as part of the KRI Starter Kit.
  • Data Quality Assessment (DQA) Overview – Introduction to comprehensive statistical data monitoring as a next step in risk detection – what it comprises and its critical importance in surfacing operational risks that may not have been anticipated via pre-study risk planning.

Risk Assessment (RACT) Starter Kit

The RACT Starter Kit includes 2 Configured RACT Profiles within the CluePoints Platform:

  • 1 Standard RACT Profile as recommended by TransCelerate
  • 1 customer-specific/study-specific RACT resulting from the initial consultation
  • Up to 20 users

Key Risk Indicator (KRI) Starter Kit

The KRI Starter Kit includes a KRI Dashboard that is configured with:

  • 8 CluePoints standard (“optimized”) KRIs
  • 2 Additional study-specific KRIs as discussed and agreed in initial consultation
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

Patient Profiles Starter Kit

The Patient Profiles Starter Kit includes the following items for Medical Review, Quality Oversight and RBM:

  • Item 1: Patient Safety – Gantt Chart View:
    – Patient Visits, Study IP Admin Dates, AEs, and ConMeds
  • Item 2: Patient Safety – Tabular listings for AEs and ConMeds
  • Item 3: Patient Measurements including
    – Line Chart(s) for 1 or 2 patient measurements of interest on the study
    – Tabular listing(s) for 1 or 2 patient measurements depicted on line charts
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

CluePoints Central Monitoring Platform Training

The RBM Starter Pack includes training on Central Monitoring Platform (CMP):

  • Introduction to the CluePoints platform, SMART engine methodology and how clients are using the solution
  • Demo of CluePoints including RACT, KRI dashboard, Signals & Action Tracking Management System, Patient Profiles, and overview of set-up process (for potential full solution use in future).
  • Access to the CluePoints eLearning Platform
  • Up to 20 users

ICH E6 (R2) and RBM Consultation

The RBM Starter Pack includes consultation that covers the following topics:

  • ICH E6 (R2) overview and an introduction to RBM methodology
  • Overview of the pre-study risk assessment & mitigation planning process, the TransCelerate RACT template, and a client-specific refinement of questions using the CluePoints RACT solution. Training will also be delivered on the CluePoints RACT tool, including a group exercise to conduct a risk assessment for a target study.
  • Key Risk Indicators (KRIs) – A review of their purpose, key considerations for optimal effectiveness, and a review of the standard KRIs proposed by CluePoints as part of the KRI Starter Kit.
  • Data Quality Assessment (DQA) Overview – Introduction to comprehensive statistical data monitoring as a next step in risk detection – what it comprises and its critical importance in surfacing operational risks that may not have been anticipated via pre-study risk planning.

Risk Assessment (RACT) Starter Kit

The RACT Starter Kit includes 2 Configured RACT Profiles within the CluePoints Platform:

  • 1 Standard RACT Profile as recommended by TransCelerate
  • 1 customer-specific/study-specific RACT resulting from the initial consultation
  • Up to 20 users

Key Risk indicator (KRI) Starter Kit

The KRI Starter Kit includes a KRI Dashboard that is configured with:

  • 8 CluePoints standard (“optimized”) KRIs
  • 2 Additional study-specific KRIs as discussed and agreed in initial consultation
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

Patient Profiles Starter Kit

The Patient Profiles Starter Kit includes the following items for Medical Review, Quality Oversight and RBM:

  • Item 1: Patient Safety – Gantt Chart View:
    – Patient Visits, Study IP Admin Dates, AEs, and ConMeds
  • Item 2: Patient Safety – Tabular listings for AEs and ConMeds
  • Item 3: Patient Measurements including
    – Line Chart(s) for 1 or 2 patient measurements of interest on the study
    – Tabular listing(s) for 1 or 2 patient measurements depicted on line charts
  • Access to the CluePoints Signals and Actions Tracking Management System
  • Up to 20 users

CluePoints Central Monitoring Platform Training

The RBM Starter Pack includes training on Central Monitoring Platform (CMP):

  • Introduction to the CluePoints platform, SMART engine methodology and how clients are using the solution
  • Demo of CluePoints including RACT, KRI dashboard, Signals & Action Tracking Management System, Patient Profiles, and overview of set-up process (for potential full solution use in future)
  • Access to the CluePoints eLearning Platform
  • Up to 20 users