Kinker Mishra

Background

About Kinker Mishra

Expert in the Application of Digital Health Technologies for Clinical Trials:1. Clinical Study Design and Digital Biomarker Validation:Extensive experience in designing and planning clinical studies to validate digital biomarkers, with a strong emphasis on creating robust protocols and reliable methodologies. Expertise spans diverse patient populations, including ALS, PD, PSP, Dementia, IBM, and Ataxia.Regulatory Affairs and Documentation2. Proficient in regulatory affairs and associated procedures, including drafting critical documents such as work instructions, validation and verification (V&V) plans, quality reports, design history files, and technical reports.3. Scientific Communication and Industry CollaborationSkilled in writing research manuscripts, posters, and abstracts for conferences to effectively communicate findings, foster collaborations, and engage stakeholders within the pharmaceutical industry.4. Advanced Biostatistics ExpertiseProficient in statistical methodologies, including ANOVA, GEE, repeated measures analysis, mixed models, and regression techniques. Experienced in using analytical tools like R, SAS, Python, and SPSS for comprehensive data analysis and interpretation.5. Regulatory Compliance and StandardsFamiliar with Industry standards such as CDISC guidelines, SDTM formats, and Good Clinical Practice (GCP) standards.6. User Experience Research in Digital HealthSkilled in applying qualitative UX research methods and selecting optimal approaches for specific contexts. Expertise includes conducting contextual inquiries, field visits, and surveys based on the Technology Acceptance Model (TAM).