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Contact Viplav K.

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Profile Details

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USD 20 /hr

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Hire Viplav K.

India

USD 20 /hr

Clinical Research Expert | Medical Writer & Scientific Reviewer | Pre-clinical Neuropharmacology

Profile Summary

I am an experienced clinical research professional with expertise in clinical trial operations, site engagement, and medical affairs, and medical writing. Currently working as a Site Engagement Liaison at ICON PLC (Pfizer), I specialize in managing global Phase I-IV trials and real-world evidence studies, ensuring compliance, audit readiness, and optimized site performance.
My previous roles at Bayer included CRA and Local Project Manager, where I oversaw Global Phase I-III studies in oncology, cardiology, neurology, and nephrology and local interventional and RWE studies in oncology, diabetes, and women’s health, handled protocol development, CRO oversight, budgeting, and regulatory submissions, and implemented risk-based monitoring strategies. I am proficient in Veeva CTMS, Medidata RAVE, Oracle Clinical, Clinion, Veeva Site Vault, Veeva TMF, RedCap Cloud and other EDC, CTMS, IRT, and ePRO systems.
I hold a Master’s in Pharmacy from ICT Mumbai and have authored multiple peer-reviewed publications in neuropharmacology, metabolic disorders, and complementary medicine. My research interests include oncology, Alzheimer’s disease, neurodegeneration, and neuroinflammation, supported by hands-on experience in experimental studies and clinical trial operations.
Services Offered
1. Clinical Trial Management & Operations
Development and review of Protocol, ICDs, IB
Patient recruitment strategies and feasibility assessments
Risk-based monitoring and compliance oversight
Data entry in applicable EDC system
2. Medical Writing & Documentation
Clinical study reports (CSR), patient narratives, and regulatory documents
Manuscript drafting and journal submission support
Literature reviews and scientific content creation
Clinical Trial Transparency and Disclosure 
3. Data Analysis
Data interpretation and visualization for publications and reports
Assistance with study design and sample size calculations
4.  Regulatory & Quality Support
SOP development and audit readiness
eTMF and CTMS management (Veeva, IMPACT)
CRO/vendor selection and oversight
5. Research Consulting
Translational research strategies (bench to bedside)
Real-world evidence (RWE) study planning
Publication planning and scientific communication

Subject Matter Expertise

Services

Writing

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Audio Transcription, General Proofreading & Editing, Translation

Work Experience

Site Engagement Liaison

ICON

September 2024 - Present

Clinical Research Associate II

Fortrea

April 2023 - September 2024

Local Project Manager (Medical Research Associate)

Bayer Zydus Pharma Pvt Ltd

July 2020 - April 2023

Clinical Research Associate

Shree Dhootapapeshwar Ltd

December 2019 - June 2020

Scientific and Regulatory Medical Writer

SIRO Clinpharm Pvt Ltd

July 2018 - November 2018

Medical Coder

Heckyl Technologies

May 2018 - June 2018

Education

Master of Pharmacy (Pharmacology) (Department of Pharmaceutical Sciences and Technology)

Institute of Chemical Technology

June 2017 - January 2020

Certifications

Certification details not provided.

Publications

JOURNAL ARTICLE

The effect of Madhumeha Kusumakar Rasa – an Ayurved medicine – in insulin resistance <head> <META HTTP-EQUIV="Refresh" CONTENT="0;URL=/servlet/useragent"> </head> . Journal of Complementary and Integrative Medicine.

Viplav Kshirsagar, Chetan Thingore, Malvika Gursahani, Nitin Gawali, Archana Juvekar(2021). Hydrogen Sulfide Ameliorates Lipopolysaccharide-Induced Memory Impairment in Mice by Reducing Apoptosis, Oxidative, and Inflammatory Effects . Neurotoxicity Research. Springer Science and Business Media {LLC}

(2021). Evaluation of anti-osteoporotic activity of Asthiposhak Tablets in ovariectomized rats. International Journal of Pharmaceutical Sciences and Research.

Viplav Vitthal Kshirsagar and Chetan Thingore and Archana Juvekar(2020). Hydrogen sulfide alleviates lipopolysaccharide‐induced memory impairment, neurodegeneration and neuroinflammation in Swiss albino mice . Alzheimer's & Dementia. 16. (S2). Wiley

Viplav Kshirsagar, Sanish Tiwari, Chetan Thingore, Dnyanesh Limaye(2020). The practice, attitude, and knowledge of complementary and alternative medicine in Mumbai, India . International Journal Of Community Medicine And Public Health. 7. (12). p. 4792. Medip Academy

(2020). Amelioration of oxidative stress and neuroinflammation in lipopolysaccharide-induced memory impairment using Rosmarinic acid in mice . Metabolic brain disease.

(2020). Insulin resistance: a connecting link between Alzheimer's disease and metabolic disorder . Metabolic brain disease.

Chetan Thingore and Ruchira Joshi and Viplav Kshirsagar and Dnyanesh Limaye(2020). A study to assess the knowledge and attitude towards HIV of pharmacy students from Mumbai university . International Journal Of Community Medicine And Public Health. 7. (10). p. 3867. Medip Academy

Chetan Thingore and Viplav Vitthal Kshirsagar and Malvika Gursahani and Archana Juvekar(2019). P2-215: ROSMARINIC ACID ATTENUATES OXIDATIVE STRESS, NEUROINFLAMMATION AND NEURODEGENERATION AGAINST LIPOPOLYSACCHARIDE-INDUCED ALZHEIMER'S DISEASE VIA JNK-3 AND CASPASE-3 INHIBITION IN MICE . Alzheimer's & Dementia. 15. p. P660--P660. Wiley

CONFERENCE ABSTRACT

(2020). Hydrogen Sulfide Alleviates Lipopolysaccharide-Induced Memory Impairment, Neurodegeneration and Neuroinflammation in Swiss Albino Mice. Alzheimer's Association International Conference 2020.

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