We offer Sponsors and CROs a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products. Underpinned by Central Statistical Monitoring, a technique that’s currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based products are deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.
We are CluePoints,
The Pioneers of Risk-Based
Study Execution(RBx) Solutions

Our Values
Passion
We work passionately to achieve our goals. We challenge ourselves and each other. We commit and we empower and we get the job done successfully.
Care
We work with quality in mind and we never accept mediocre. Rushing is never the solution and overcommitting often results in disappointment. We value quality over quantity.
Respect
We are all in the same boat together. We work in full transparency with compassion and trust.
Inspiration
We embrace creativity (not just in our software products) and constantly look to advance.
Awards
We've had a few and we're not shy about it.
Our Team
Say hello to our team, each a master of their respective craft.
- The aim of the Parexel and CluePoints collaboration is to drive the quality, accuracy, and integrity of clinical trial data both during and after study conduct as well as increase productivity, efficiency and cost effectiveness for sponsors.
- The value to the industry from this collaboration is extensive. CluePoints is in the business of building technology to increase efficiency and patient safety with improved data quality, while ZS’s innovative ‘control tower’ methodology offers a portfolio-level management tool to oversee quality across studies, processes and providers.
- Our partnership with Quanticate, a data-focused clinical research organisation (CRO), has enabled Quanticate to utilize our software to drive the statistical analysis to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service that enables centralized statistical monitoring, in response to the amendments to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.
- Our collaboration with Oracle Health Sciences, combines CluePoints’ award-winning Risk-Based Monitoring (RBM) solution with Oracle’s clinical data capture and management platform, Oracle Health Sciences Inform Cloud Service. The resulting solution can help deliver a complete trial review process that proactively identifies risk in both clinical and operational data throughout a clinical trial.
- GSK Vaccines business is one of the largest in the world, with over 1.1 billion doses distributed to paediatric and adult patients in 173 countries to prevent a range of infectious diseases. GSK have partnered with CluePoints® to assist in the development of the SMART™ engine by providing numerous active clinical trial data sets to use for pilot projects and in order to perfect the matrix of statistical algorithms used in the product.
- IDDI (International Drug Development Institute) has been providing eClinical and Biostatistical services provider for clinical trials since 1991. IDDI has been instrumental in developing the SMART™ engine that drives the complex statistical algorithms within the CluePoints® solution.
- The Institut De Statistique, part of the Université Catholique de Louvain in Belgium, was founded in 1992 and coordinates all the teaching and research activities within the university in the areas of biostatistics, mathematical statistics and quantitative analysis of insurance and financial risks. This research group has been one of the academic partners involved in the development of the SMART™ engine.
ALL TRADEMARKS, SERVICE MARKS AND LOGOS DISPLAYED ABOVE ARE THE PROPERTY OF THEIR RESPECTIVE OWNERS AND MAY NOT BE USED, REPRODUCED, OR MANIPULATED IN ANY MANNER WITHOUT THE EXPRESS, WRITTEN APPROVAL OF THE TRADEMARK OWNER.