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Regulatory Support

Regulatory Support

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Whether you need support in clinical and observational studies or communications materials, our experienced medical writers can help you with that.

Our writers possess the skills and relevant medical education to compile, organize, write, edit and produce expertly written documents.

We maintain a library of International Conference on Harmonization (ICH) templates and Standard Operating Procedures (SOPs), but we can also use client templates and follow client style guides upon request.

Our Medical Writers can assist at any point in basic and pre-clinical research, and in the product development lifecycle across Phase I to Phase IV, and have experience in a wide array of documents, including:

  • Regulatory writing:
    • Synopses
    • Protocols
    • Patients Self-Administered Questionnaires
    • Case Report Forms
    • Patient Information and Informed Consent Forms
    • Pediatric Investigational Plans
    • Interim and final Clinical Study Reports
    • Review of statistical analysis plans and mocking statistical output to assist in determining appropriateness of content/format for clinical writing
  • Medical communication and publications:
    • Booklets
    • Clinical Pathways
    • Flowcharts
    • Advisory Board Summaries and Reports
    • Medical Education Materials
    • Web Contents
    • Oral Presentations, Manuscripts, Abstracts and Posters
    • Fellowship Application
    • Grant / Proposal Writing with Local and International Funding Bodies

Our medical writers will increase the acceptance of your manuscript in a peer-reviewed journal (acceptance rate of our manuscripts is over 90%).

Our medical writers ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.

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Study Feasibility

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Medical Writing

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Regulatory Support

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Clinical Monitoring

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Project Management

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Biostatistics Services

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Patient’s Recruitment & Retention Programs

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Health Economics

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Support to Study Site Staff

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Insourcing & Outsourcing

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Electronic Solutions (eCRF, digital tablet)

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Trainings & Workshops

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Data Management

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Staffing Services

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Patient Support‍ ‌Programs