Mani Kanta Email and Phone Number

• Follows established guidelines for the review of clinical trial data using a variety of tools and systems • Review the RIs such as data entry currency, Query management, Subject enrollment, deviations, Adverse events, potential fraud, medical history, treatment compliance and their sub RIs.• In alignment with the centralized monitoring plan independently with little/no support • Analyze the data and update the findings and observation in the jira reporting format. • Characterizes and tracks the evidence of issues, signals and potential risks with inputs as needed from DA Lead/Manager. • Responsible for ensuring results of reviews are appropriately documented per department procedures. • Supports DA teams with performance of assigned reviews with high quality, on-time results with more • complex analyses or deeper root cause analyses and begins to connect related signal to risks • Provides input to Lead and/or Manager as needed to support development of risk characterization and reporting. • Supports review set-up as directed by assigned study lead/manager including updating department

Monitoring the site performance through defined "key risk indicators" by using real time applications.

1.Centralize Monitoring2.Medical Data Review3.Risk Base Monitoring 4.Trend Review 5. Data Cleaning

• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages• Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial• Ensures proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial• Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient• Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)• Review any other information as necessary to determine overall readiness of the patient information for next level review• Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points• Review status information and data flow reports and take appropriate actions• Serve as POC/ Back-up POC• Interaction with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Left Lotus Labs , joined Quintiles Technologies

Promoted to Senior Clinical Research Coordinator