I will write clinical trial documents and protocol summaries

M
mchillik
M
mchillik
Maalika Ch

About this gig

I am a clinical research professional with 8+ years of experience supporting Phase IIV clinical trials across oncology, cardiovascular, diabetes, and medical device studies.

I provide high-quality clinical trial document writing and protocol summaries that are clear, structured, and aligned with ICH-GCP, FDA, and regulatory standards. My goal is to help sponsors, CROs, startups, and academic teams communicate their study design accurately and professionally.


Services I offer include:

  • Protocol summaries (lay & technical)
  • Clinical study documents
  • Regulatory narratives and reports
  • Investigator brochure summaries
  • Study design overviews
  • Document formatting and compliance review


Why work with me?

  • Real-world clinical research and CRA/CRC experience
  • Strong attention to regulatory compliance and data integrity
  • Clear communication and on-time delivery
  • Confidential and professional handling of sensitive data


Please message me before ordering to discuss your project requirements so I can ensure the best outcome.

Get to know Maalika Ch

Maalika Ch

Clinical Research and Medical Documentation Specialist

  • FromUnited States
  • Member sinceJan 2026
  • Avg. response time9 days
  • Languages

    English
I am a Clinical Research & Medial Documentation Specialist with 8+ years of experience supporting Phase I–IV clinical trials across oncology, cardiovascular, diabetes, dermatology, and medical device studies. I work with CROs, sponsors, and research sites to deliver accurate, compliant, and audit-ready documentation aligned with ICH-GCP, FDA 21 CFR Part 11, and HIPAA. My expertise includes protocol summaries, regulatory and medical writing, IRB support, clinical data entry and validation, and TMF/eTMF organization. I am detail-oriented, reliable, and committed to high-quality, on-time deliver