Profile Details

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USD 22 /hr

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Hire Dr. Shivam B.

India

USD 22 /hr

Clinical & Regulatory Medical Writer | Protocols, CSR, IB, CTD | ICH-GCP | Phase I–IV

Profile Summary

I am a Pharm.D-qualified Clinical & Regulatory Medical Writer with hands-on experience in CRO-based clinical research and submission-ready documentation. I specialize in drafting and reviewing protocols, IBs, ICD/ICFs, CRFs, CSRs, and patient-facing materials aligned with ICH-GCP, NDCT, and global regulatory standards. I also support regulatory writing, including CTD Module 2 (2.5/2.7), DSUR, GIP, and annual safety reports, ensuring scientific accuracy, consistency, and traceability. My experience spans Phase I–IV studies across multiple therapeutic areas including oncology, dermatology, respiratory, HIV, endocrinology, and rare diseases. In addition, I contribute to manuscript writing, systematic reviews, and publication support (ICMJE/GPP3 aligned), along with targeted literature reviews to strengthen scientific rationale. With exposure to CRA activities and cross-functional collaboration, I deliver high-quality, submission-ready documents efficiently.

Subject Matter Expertise

• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Clinical Data Management
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Research Summaries & Abstracts

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Work Experience

Senior Medical Writer and Principal Medical Writer

Clinexcel Research

July 2024 - Present

Education

PharmD (Doctor of Pharmacy)

L M College of Pharmacy

August 2019 - July 2024

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Bhavarth P. Dave, Mehul R. Chorawala, Ishika V. Shah, Nidhi N. Shah, Shivam U. Bhagat, Bhupendra G. Prajapati, Pratik C. Thakkar (2024). From diabetes to diverse domains: the multifaceted roles of GLP-1 receptor agonists . Molecular Biology Reports.

Shivam Bhagat, Mansi Shah, Bhavarth Dave, Hetansh Rao, Avinash Khadela, Nisha Parikh (2024). A comprehensive review comparing conventional versus traditional remedies in the treatment of endometriosis with futuristic insights . Future Journal of Pharmaceutical Sciences.

Shivam Bhagat, Avinash Khadela, Shruti Soni, Kaivalya Megha, Vivek Chavda (2023). A Review on the Impact of the SARS-CoV-2 Omicron Subvariant on Elderly Patients with Diverse Co-Morbidities . Biologics.

PREPRINT

Shivam Bhagat, Avinash Khadela, Bhavarth Dave, Yesha Shah, Priya Mistry, Bhavin Shah, Sanket Shah (2023). Comparative Evaluation of Effectiveness and Safety of First and Second Generation Tyrosine Kinase Inhibitors (TKIs) in Patients with BCR-ABL Positive CML in Chronic Phase .