プロフィール詳細

プロジェクトを作成

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Babita G.に依頼

India

Managing Director, Syntrialis LifeSciences | Expert in End-to-End Clinical Trial Site Management & SMO Operations

プロフィール概要

Managing Director & Clinical Research Leader | Associate Professor of Pharmacognosy Dynamic and results-driven Pharmaceutical Scientist and Clinical Research Executive with over a decade of combined experience spanning academic research, institutional compliance, and end-to-end clinical trial site management. Currently serving as the Managing Director of Syntrialis LifeSciences, a registered Site Management Organization (SMO), leading cross-functional teams to deliver high-quality, GCP-compliant clinical operations for global sponsors and CROs. Core Expertise & Clinical Operations: SMO Leadership & Site Management: Overseeing overall corporate management, strategic planning, and business development to connect principal investigators with active clinical trials. End-to-End Trial Execution: Directing cross-functional teams in site feasibility assessments, ethics committee (IEC/IRB) submissions, patient recruitment strategies, and protocol adherence. Data Integrity & Compliance: Deeply well-versed in ICH-GCP E6(R2/R3), NDCT 2019, and CDSCO guidelines. Proven track record in managing Trial Master Files (eTMF), Electronic Data Capture (EDC) systems (Medidata, Veeva), and preparing sites for robust sponsor audits and regulatory inspections. Academic & Research Background: Pharmaceutical Formulation & Evaluation: Advanced expertise in natural product research, phytochemical profiling, herbal drug standardization, and phytopharmacological screenings. Published Research: Authored peer-reviewed research in reputed journals, including specialized work on cellulose derivatives as thermoresponsive polymers and antihyperglycemic activity models. Institutional Leadership: Former Associate Professor at SAGE University, Indore; expert in guiding postgraduate research projects and managing high-level institutional quality assurance and accreditation compliance (NAAC, NBA, NIRF). A registered pharmacist with the Uttar Pradesh Pharmacy Council and NIDA GCP certified, dedicated to bridging the gap between clinical research excellence, regulatory compliance, and innovative patient care.

専門分野

• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

職務経験

Managing Director

Syntrialis LifeSciences

2026 - 現在

Associate Professor

SAGE University Indore

1月 2026 - 3月 2026

Assistant Professor

SAGE University Indore

10月 2023 - 12月 2025

Assistant Professor

Sagar Institute of Research, Technology & Science – Pharmacy

11月 2011 - 11月 2019

学歴

M.Pharma (Pharmacognosy) (Pharmacy)

RGPV

2009 - 2011

B.Pharma (Pharmacy)

RGPV

2005 - 2009

認定資格

• Good Clinical Practices (ICH GCP E6 R2)

  NIDA

  1月 2025 - 1月 2026

出版物

REVIEW

Babita Gupta (2013). Cellulose Derivative as Thermoresponsive Polymer: An Overview. Journal of Applied Pharmaceutical Science, Vol. 3(12), 139–144, Dec 2013.

JOURNAL ARTICLE

Babita Gupta (2013). Antihyperglycemic Activity of Polygonum orientale Linn Flowers Using streptozotocin -Induced Diabetic Mice. International Journal of Pharmacy & Life Science, Vol. 4(5), May 2013.

Babita Gupta (2013). Antihyperglycemic Activity of Polygonum orientale Linn Flowers Using streptozotocin Model. International Journal of Pharmacy & Life Science, Vol. 4(5), May 2013.