Medical
Writing

Clinical Trial
Disclosure

Project
Management

    Medical Writing

    I have a wealth of experience in medical writing. Services noted below are not exhaustive. I am happy to provide services for other document types, including promotional material. Please get in touch, and I’d be happy to discuss further.

    Regulatory Documents:

  • Clinical Study Protocols and Clinical Study Reports
  • Pre-clinical reports
  • Investigator’s Brochures (IBs; full and core-data sheet format) and Investigational Medicinal Product Dossiers (IMPDs)
  • Investigational New Drug applications (INDs) and annual reports
  • Briefing documents (EMA, FDA)
  • Common technical document (CTD) summaries
  • Regulatory response documents
  • Paediatric Investigational Plans (PIPs) and PIP modification
  • Orphan Drug Designation
  • Guidance on redaction of clinical-regulatory documentation (See Clinical Trial Disclosure)
  • Guidance on authoring clinical-regulatory documentation to minimise the need for redaction (See Clinical Trial Disclosure)
  • FDAAA clinical trial disclosure summaries

    • Other Documents/Services:

  • Training materials
  • Slide decks
  • Newsletters
  • Standard Operating Procedures
  • Document review
  • QC of documents/slides/articles

    Clinical Trial Disclosure

    I was the AstraZeneca business lead for Redactions and a core team member of the AstraZeneca Clinical Trial Transparency Taskforce since its inception (for over a year). I gained a wealth of knowledge and experience during this time.

    Below is a snapshot of how Clariscript Communications Ltd can help your business understand and comply with EMA Policy 0070 legislation. Please feel free to get in touch if you would like to discuss further.

    How we can help you:

  • Help your business understand the evolving EMA Policy 0070 legislation, what this means for you, and how you may go about embedding this change into your organisation
  • Provide guidance on what may need to be redacted from clinical-regulatory documents to protect patient privacy and company confidential information
  • Provide guidance to your business in terms of how to facilitate disclosure of clinical documents by authoring to minimise the need for redactions
  • Provide guidance on business processes (Redactions)
  • Provide guidance on training, particularly in the Redactions arena
  • Provide insight into lay language summaries

    Project Management

    I have extensive experience working with multi-disciplinary teams, including senior stakeholders, on a global level. To ensure high-quality documents were produced on time required strong project-management skills.

    I spent over 2 years working in a customer-facing role for a contract research organisation. I was responsible for a wide variety of different clients across the globe. Please see my LinkedIn profile for a number of recommendations that I received from that role, including one from the Chief Scientific Officer.

    I am happy to discuss any project management needs that you may have. Please get in touch to discuss further.