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Why Megalek
MEDICAL WRITING TEAM
  • Offers guidance with open advice on clinical documentation
  • Including publishing and submission readiness
  • Dive into the details to deliver the documentation with full regulatory compliance
  • Manage and optimize document development to meet timelines
CLINICAL DEVELOPMENT SOLUTIONS OVERVIEW
MEDICAL WRITING TEAM
  • Offers guidance with open advice on clinical documentation
  • Including publishing and submission readiness
  • Dive into the details to deliver the documentation with full regulatory compliance
  • Manage and optimize document development to meet timelines
  • PROTOCOL DEVELOPMENT (INCLUDING SYNOPSIS AMENDMENTS)
  • INFORMED CONSENT FORMS
  • CLINICAL STUDY REPORT (PHASE II-IV)
  • DEVELOPMENT SAFETY UPDATE REPORT
  • INVESTIGATOR BROCHURE
  • PATIENT MATERIALS, INVESTIGATOR MEETING MATERIALS
  • REGULATORY AUTHORITY RESPONSES
Give your regulatory submission the best chance for approval with well written regulatory documents throughout of all the stages of clinical development process.
Medical Writing is an integral part of clinical research, and our team of medical writers deliver accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards.
We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry and clinical research organizations. All documents produced by NEA Clinical undergo through scientific, statistical and quality control review.