Harit Nandani
Principal Consultant
I am a seasoned clinical development leader with a interdisciplinary background in healthcare sciences technology with experience driving decisions in biotech, diagnostics, and healthtech organizations.
A few highlights from my work experience include leading data management and analytics for Phase 3 pivotal trials for NDA submissions, working with large national and academic partners in the US (Mayo, Clevaland Clinic) and UK (NHS, University of Oxford) to implement population scale trial workflows, complex oncology trials data migrations and development of modern data visualization tools.
My collaborative approach combines deep technical excellence with domain knowledge to deliver solutions that scale.
Key Expertise
Clinical Data Expertise
Deep understanding of clinical trial processes, GCP, and regulatory requirements (FDA, EMA, ICH)
Technical Proficiency
Responsible, compliant AI and LLM use, advanced data visualization, exploratory data analysis, statistical programming, web-based tools and APIs, and knowledge of cloud-based tools (AWS, GCP)
Systems Configuration and Integration
Seamless configuration and optimization of EDC, IRT/IWRS, and data management platforms
Data Partnerships and Requirements
Leading data requirements and partnershups with CROs, registries, large healthcare systems groups, and external data sources
Leadership
Proven track record leading cross-functional teams and mentoring data management professionals, developing standards and procesed
Therapeutic Area and Domain Experience
Professional Background
Education
M.S in Pharmaceutical Sciences
Specializaton in clinical trials and drug development
B.S in Pharmaceutical Sciences and Economics
Advanced Coursework in Data Analytics
Select Publications and Patents
Systems and Methods for Automated Document Classification – USPTO, April 2022
Automated Extraction of Breast Density from Mammogram Reports – USPTO, April 2021
A retrospective analysis of the validity and timeliness of cancer diagnosis data collected during a prospective cohort study and reported by the English and Welsh cancer registries, Lancet Oncology, Aug 2024
Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study. Lancet Oncol. 2023 Jul;24(7):733-743. doi: 10.1016/S1470-2045(23)00277-2. Epub 2023 Jun 20. PMID: 37352875.
Large-scale observational prospective cohort study of a multi-cancer early detection (MCED) test in symptomatic patients referred for cancer investigation. Journal of Clinical Oncology, Volume 41, Number 16