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Case Study: How CluePoints Detected Fraudulent Reporting of Investigational Product Administration from Patient Diary Data

Patient diaries are increasingly used in clinical trials to capture information such as outcomes or treatment intake directly from the patients. A pharmaceutical company was conducting a large phase III cardiovascular trial where information about Investigational Product administration by patients was collected at the sites before randomisation and through patient diaries after randomisation. The Sponsor was looking for a fast and efficient solution to detect potential issues at the study sites and in patient data. CluePoints was chosen to perform an overall data quality assessment of their data throughout the course of the trial.

Download the case study to discover how CluePoints detected fraudulent reporting in a large phase III cardiovascular trial.

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Case Study: Using CluePoints to Detect Anomalies in Electronic Patient-reported Outcomes

Offering many benefits to clinical research due to their innate ability to enhance data quality and efficiency for the collection of electronic patient reported outcomes (ePRO), while also improving data analysis and trial management, devices such as electronic patient diaries have become common practice within today’s clinical trials.

Download the case study to discover how CluePoints detected fraudulent activity related to the use of electronic devices used for patient diaries in a phase III trial in chronic disease.

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Case Study: Using CluePoints to Identify Severe Propagation in Vital Sign Measurements

In clinical trials, questions about propagation (replication or duplication) of vital sign measurements may be raised when sequences of values are observed. Issues of propagation have been reported in trials that involve measurements being repeatedly collected across numerous patient visits.

Download the case study to discover how CluePoints assessed the quality, accuracy and consistency of the phase III ophthalmology study after its completion.

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Case Study: Using CluePoints to Identify Fraud Due to the Fabrication of Patient Diaries

The use of patient diaries is frequently used in clinical research to capture detailed insights directly from participants without oversight by study administrators.

Though highly beneficial, the very nature of this tool leaves it open to the potential for entries to be falsified. A leading pharmaceutical company had been losing confidence in the data being generated through patient diaries at an investigative site involved in a phase III trial in patients with vascular disease.

Download the case study to discover how CluePoints detected the real issues within this study with suspected fraud in Patient-Reported Outcomes data.

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Case Study: Using CluePoints to Detect Miscalibrated Equipment in a Clinical Trial

Proper calibration of equipment including ECGs, thermometers and blood pressure monitors is necessary to eliminate the potential for bias in an instrument’s readings and make certain of the quality of reported results. A pharmaceutical sponsor wanted to gain a complete insight into the occurrence of data discrepancies arising from miscalibrated equipment in an on-going phase III vaccine trial.

Download the case study to discover how CluePoints provided a detailed analysis of the device calibration issues across all sites involved in the trial.

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Case Study: The Value of the CluePoints Solution in Identifying Under-reported Adverse Effects in a Clinical Trial

Adverse events which occur during the course of clinical trials must be appropriately identified, recorded and reported to ensure continuing patient safety and the quality, accuracy and integrity of trial data.

Failure to correctly identify non-serious and serious adverse events, and deal with them adequately, while also following the required reporting procedures, can have significant implications on clinical research and regulatory submissions. A pharmaceutical sponsor had specific concerns about some investigative sites involved in a phase III study in infectious disease.

Discover how CluePoints detected that the investigative sites were mis-classifying different types of Adverse Event.

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Case Study: Using CluePoints to Reveal Protocol Deviations in Patient Selection

Every clinical trial protocol requires a set of criteria to be developed that describes the types of patients who are eligible to take part in the research, with the aim of creating a desired population from which study data can be collected.

Patients are included in a trial only when they have satisfied a set of inclusion and exclusion standards based on the research objectives of a particular study and covering factors such as age, disease stage, gender and treatment history.

Download the case study to discover how CluePoints identified the patient selection and treatment discontinuation issues during a phase III trial in cardiovascular disease.