Illuminated Research provides a range of medical writing services intended to assist with the development of pharmaceutical drugs and devices. To learn more about the services we provide, please select from the following areas of expertise:

Development of Clinical Study Documents


  • Consulting services associated with the design of clinical studies and the preparation of associated documents

  • Authorship of ICH-compliant study protocols

  • Preparation of informed consent/assent documents

  • Assistance with institutional review board/investigational ethics committee (IRB/IEC) submissions

  • Design and printing of case report forms and other data collection instruments (eg, subject diaries)

  • Authorship of investigator brochures

Preparation of Regulatory Submission Materials


  • Authorship of information intended for inclusion in regulatory agency briefing packets

  • Complete authorship of ICH-compliant clinical study reports (CSRs)

  • Development of clinical sections (ie, Module 2) within the common technical document (CTD) framework

  • Development of clinical portions of premarketing approval applications (PMAs) and other device submission dossiers (eg, 510[k] applications)

  • Authorship of stand-alone integrated summaries of efficacy and safety

  • Publication of reports and dossiers in an FDA-compliant, portable document format (PDF)

  • Preparation of granulated CSRs for "drag and drop" inclusion in electronic CTD submissions

Authorship of Scientific Communication Materials


  • Authorship of manuscripts compliant with the Consolidated Standards of Reporting Trials (CONSORT) statement

  • Management and tracking of online journal submissions

  • Generation of supporting figures in encapsulated postscript (EPS) format to meet journal requirements

  • Authorship and submission of poster abstracts

  • Design and printing of poster presentations

  • Authorship of product monographs, including the layout and presentation of text, figures, and tables

Consulting and Quality Control Activities


  • Consulting regarding clinical conduct best practices, submission requirements, and development of complex messaging

  • Assistance with literature searches conducted across medical, toxicological, and chemical databases

  • Summarization and presentation of detailed literature search results

  • Preparation of document templates and style guides in accordance with best practices and both FDA- and ICH-requirements

  • Proofreading of written materials to confirm accuracy and appropriateness of content

  • Quality control reviews of written materials to ensure consistency, accuracy, and guideline compliance

  • Medical editing services