our services

Medical Writing Expertise

Tech Observerís medical writers work closely with your statistical, medical, regulatory and data management teams to deliver meticulously accurate, timely and cost-effective documents to the highest ethical and scientific industry standards.
Our clinical writing process involves a sequence of scientific, statistical, editorial, managerial and quality control reviews at each developmental step. From the initiation of a project to the final document, Tech Observer maintains a high level of communication with you, ensuring that the document content and format fully meet your expectations and requirements. Tech Observerís medical writing services include clinical and regulatory writing as well as scientific communications, educational material and medical writing consultancy.

Our Services include:
  • INDs/PMAs/IDEs/CTAs

  • NDAs/BLAs/PLAs/MAAs

  • ICH-GCP compliant Clinical Study Reports (CSR); Phases I to IV, including Clinical Study Report Synopses for Public Disclosure

  • Protocol Development

  • Clinical and Non-Clinical Sections of the Common Technical Document (CTD) including Summaries and Overviews for EU or US Regulatory Authorities

  • Investigator Brochures

  • Patient Safety Narratives

  • Patient Information Including Informed Consent and Patient Brochures

  • Periodic Safety Update Reports

  • ISS&ISE

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