Case Study 1
Case: An Indian Pharmaceutical Company conducted derma trial in the USA.
Challenge: The CRO conducting the trials got shutdown in between. Achievement: Karmic data management team have taken the incomplete project from the mid way, performed data cleaning and successfully achieved database lock with 99.95 % Quality Index.
Outcome: This helped the sponsor to submit the data to USFDA without any finding.
Case Study 2
Case: A global Bio-pharmaceutical company conducted Oncology trial in the USA.
Challenge: Sponsor has identified enormous data inconsistency in a trial conducted by another CRO. Hence, the sponsor contacted Karmic DM to re-perform SDV and data cleaning in very short timeline
Achievement: Karmic data management team completed the SDV, data cleaning and discrepancy management within provided timeframe.
Outcome: This helped the sponsor to perform regulatory submission in timely manner with the upmost data quality.