Enable Medical Review and Enhanced Centralized Monitoring

The CluePoints Patient Profiles Starter Kit gives sponsors an ideal introduction to Patient Data Review and how risks can be targeted by ranking patients according to how atypical they are. Our team of RBM experts will train your team on how to use these Patient Profiles, and will configure Patient Profile reports that visually present the most relevant information in your studies. Standard visualizations will include a chronological (Gantt chart) view of a patient’s visits, investigational product exposure, adverse events and concomitant medications.  Additional views will include tabularized safety data along with other key study measurements.

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.

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.

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