Clinical trial analyticsfor trial set-up, site selection, monitoring and optimization

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Site Investigator Dashboard (1/2)Patient Enrolment

• Record the patient’s information as required by inclusion and exclusion criteria

• Compare the patient’s profile with the clinical trial requirements suggesting the site investigator to enroll or reject

• This information (Patient enrollment) could be useful for clinical trial sponsor to track the protocol deviation in enrolling patients

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Enroll Patients

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Site Investigator Dashboard (2/2)Site Enrollment Tracker

• Summarizes the #of subjects enrolled till date

• Estimates the #of additional days that would be required to reach the target with current enrollment rate

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Track Enrollment

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Management Dashboard (1/5)Clinical trial configuration

• As a Clinical trial sponsor, design the various requirements of a trial • Sites configuration:

• Selection of the list of sites for the clinical trial

• Tool predicts the #of subjects to be enrolled (accounting for the drop-off rate at the site) to reach the target enrolment

• Inclusion/Exclusion criteria configuration

• Miscellaneous configuration:

• Include prioritization during enrollment

• Other important protocols for the clinical trial

• Switch between multiple on-going clinical trials and track the progress

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Set up & Manage Clinical Trials

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CAX e-Screening Platform: Management Dashboard (2/5)Best Site optimization

• Identify the best (time & cost efficient) sites with the help of CAX Site scores which is calculated based on • Patient availability• Enrollment rate•Drop-off rate•Historical Clinical trials• Investigators qualification• Investigators availability

• Compare the initial Sites selected for the trial with CAX suggested ‘Best’ sites

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Best Site optimization

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Management Dashboard (3/5)Manage Enrollments

• Understand the overview of enrollment rate for the given clinical trial across each sites• Comparison of #of subjects enrolled till date

vs. #of subjects should have been enrolled (based on Site’s history) after ‘nth’ day

• Analyze the enrollment progress at each site in a detailed manner :• Compare the trend of enrollment rate across

sites

• Estimate the additional #of days required to reach the target subjects for the trial based on current enrollment trend at each sites

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Manage Enrollments

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Management Dashboard (4/5)Track Protocol Deviations

• Observe & analyze the lab readings of each patient at every site

• Identifying any protocol deviation in the clinical trial lab recordings like:• Missing data

• Outlier data

• Junk values

• Inclusion/Exclusion criteria deviation

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*FDA encourages risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality

Track Protocol Deviations

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Management Dashboard (5/5)Track Patient parameters

• Statistically measure the key patient parameters during the trial• Drug’s efficacy• Patient safety• Patient/Site drop-off rate• Optimal dosage at a patient & site level

• Identify the potential safety risks & efficacy of the drug• This helps in calling off the clinical trial at an

earlier stage if safety risk is statistically high or Drug’s efficacy is statistically low across all site, thus saving substantial cost

• Identifies demographic based safety risk of the drug if the safety risk is higher for sites located at certain regions

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Track Patient parameters