Conclusions and Direction from Executive Roundtable on Response to ICH E6 (R2)

Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides an updated view of the Industry response to ICH E6 (R2) and documents key themes that were observed at this year’s meeting.

The Evolution of Clinical Data Management to Clinical Data Science

Created in conjunction with our peers at SCDM, Allergan and Pfizer, the objective of this paper is to provide a forward‐looking and pragmatic view on why and how emerging study designs, regulations and technology innovations are reshaping the role and profile of CDM. This paper particularly examines the industry drivers and trends in Clinical Research and their direct impact on CDM. The paper concludes by providing organizations, leaders and SMEs initial insights on the evolution of the CDM role and associated best practices in our journey from traditional Clinical Data Management to Clinical Data Science.

Implementing a Scalable Risk-Based Monitoring Strategy

Download the whitepaper to learn:

  • Best practices based on lessons learned from actual RBM initiatives
  • The importance of Risk-Based Monitoring/ Risk-Based Quality Management
  • How to establish your business objectives
  • Defining your approach
  • Managing the change

Senior Leadership Forum –  Sponsor Responses to the New ICH E6 Revisions

Download the whitepaper to learn:

  • How companies are responding to the ICH E6 Addendum
  • What areas are most expected to be impacted
  • What revision elements show the widest differences in interpretation between companies
  • What challenges companies have seen

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The Principles of Central Statistical Monitoring

CluePoints showcases the principles of Central Statistical Monitoring as advocated by the various regulators in their guidance on the topic of Risk-Based Monitoring.

  • The practical implementation of the methodology
  • Case studies that identify the various data discrepancies and anomalies
  • How to increase data quality and reduce costs through the practical implementation of CluePoints

ensuring

Ensuring Trial Validity by Data Quality Assurance and diversification of monitoring methods, Clinical Trials published in 2008

Central Statistical Monitoring as advocated by the regulators in their guidance documents on the topic of Risk-Based Monitoring and Data Integrity Assurance.

  • The types of errors arising in randomized trials, and the circumstances under which they might introduce bias or adversely affect patient safety during the trial
  • The types of monitoring techniques available and their efficacy for detecting the types of errors we have identified
  • How risk assessment can be used to identify the likelihood of those errors, thereby guiding the monitoring plan

cluepoints whitepaper

All you need to know about SMART™, the engine that drives CluePoints

Everything you wanted to know about the CluePoints SMART engine:

  • The CluePoints methodology
  • Statistical methods for the detection of fraud and other data anomalies
  • The statistical principles underpinning the SMART engine

cluepoints statistics

Statistics in Medicine – The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials – Statist. 1999

Within his white paper, you will find an overview of the role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. CluePoints showcases the principles of Central Statistical Monitoring to detect data fabrication (making up data values) and falsification (changing data values) as advocated by the regulators in their guidance documents on the topic of Risk-Based Monitoring.