Prashanth Prakash

About Prashanth Prakash

I am working as Sr. Safety Associate at Norwich over 3 years with presently QC review of…

Experience

1. Sr Medical Data Reviewer

   IQVIA

   Sep 2013 — Present · Bangalore, IN

   1) To review and identify anomalies in subject reported data that require further investigation with the clinical site to determine overall accuracy.2) To review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages.3) To 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 fora reported AE.4) To review all inclusion and exclusion criteria to ensure each subject meets minimum level of acceptance into the clinical trial5) To ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the subject ending participation in the clinical trial.6) To 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 subject.7) To review all subject 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.).8) To review additional information, as necessary, to determine overall readiness of the subject\'s data for scientific, data or trend analysis.9) To review all supplied Line Listings to determine data accuracy across subjects within a specified group of data points.10) To review status information and data flow reports and take appropriate actions11) To Interact with other Medical review staff to verify/clarify information and/or triage new data issues12) To attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Education

• Vinayaka Mission's Research Foundation - University

  Masters, Biochemistry

  2010 — 2012

• Cranfield University

  Master of Science (MSc), Clinical Research

  2005 — 2007

• Bangalore University

  Bachelor of Science (BSc), Chemistry, Botany and Biotechnology

  2002 — 2005

Skills

• Sop
• Medidata Rave
• Spotfire
• Oracle Clinical and Remote Data Capture ( Ocrdc)
• Clinical Research
• Pharmacovigilance
• Clinical Data Management
• Protocol
• Ich Gcp
• Clinical Trial Coordination and Site Management
• Data Trend Analysis
• Risk Based Monitoring / Centralized Monitoring
• Microsoft Office
• Strategic Planning
• Ctms
• Ich-Gcp