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Summary
Kalyan has passion for conceptualizing and implementing unique solutions to improve business efficiencies in the Clinical arena. He has been involved in complex Drug development data and systems integration projects from mid nineties, when clinical data industry standards didn't quite exist.
Kalyan has the unique ability to intersect his clinical domain insight with leading technologies and industry standards. He has successfully architected comprehensive solutions resulting in delivering cross functional insights within drug research, clinical, and pre/post marketing phases - all while adhering to global regulatory requirements and industry standards.
Specialties
- CDISC, SDTM Legacy conversions
- Clinical Data Warehousing
- SAS programming
- Master Data Management (MDM)
- eSubmissions
- Life sciences intelligence (CTMS, EDC, CDM, PV)
- Business process modeling
Specialties
- 2006 CDISC Interchange - Legacy Conversion of Clinical Studies & Clinical Data Warehouse
- 2007 DIA EDM Conference - Practical Consideration related Compliance in implementing COTS products in Clinical and Regulatory areas
- 2008 DIA Annual Conference - Clinical Data Mining/Signal Detection and eAuditing utilizing CDISC SDTM Data Standards
- 2009 DIA Annual Conference - Multiple Regulatory Agencies Compliant Clinical Data Preparation (CDISC) - Practical Challenges Faced
- 2010 ISCR Annual Conference - Data Standards in Clinical Research: Challenges and Future Directions & Defining Transformation
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