Services

We Can Help You

         Pharmaceutical


Clinical Study Protocols

Clinical Study Reports (CSR)

Informed Consent Forms

Patient Narratives

Investigator Brochures

CTD Module 2 Summaries for Food and Drug Administration (FDA) and European Medicines Agency (EMA) submissions

Integrated Summaries of Safety (ISS)

Integrated Summaries of Efficacy (ISE)

Experienced working on components of New Drug Appplications (NDA),Investigational New Drugs (IND), Biologics License Applications (BLA) and Marketing Authorisation Application (MAA)

Health Authority Questions

Briefing Documents


           Device


Clinical Investigational Plans

Clinical Investigational Reports

Clinical Evaluation Reports

Lay Summaries

        Editing


Scientific peer review

Editing

Peer Review

Formatting

Quality Checks


Preparation of Standard Operating Procedures (SOP)

Work Instructions & Guidelines

Training & Mentoring


Writing for Human Medicine and Veterinary Medicine




TESTIMONIAL

I have had the pleasure to work with Rebecca for over 10 years while she was leading the Medical Writing Department at a Clinical Research Organisation. Rebecca understands the meaning and importance of timelines to her clients. At critical times, she is able to integrate herself within a sponsor team where her combined medical writing expertise and clinical research experience are valued. Rebecca is professional and proactive with high expectations of her work and leads by example.

Senior Management, CRO