medical writing

Medical Writing

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Flexible professional medical writing services – exactly when you need them.

Medical Writing ServiceWorking with PDS means you have a highly respected and trusted partner, with experience in a broad range of therapeutic areas and product types.

Our flexible medical writing services allow you to eliminate recruitment costs, while benefiting from our broader pool of experienced medical writers. Maximise your internal resources by supporting them with PDS’s vastly experienced team of medical and scientific professionals. Delegate critical medical writing to our TEAM and let us help you to deliver the results you need.

Call on us to help with the key areas where you most need support and maximise your return on investment. Whatever your medical writing and/or medical communication needs, we aim to meet your expectations. Our experience and expertise covers a wide range of therapeutic areas and also in preparing quality documents for all stages of drug/product development.

We understand your needs,  those of your different target audiences and we will ensure the delivery of writing projects to meet such needs.

  • Pure Drug Safety has the scope to cover all required areas of expertise
  • We have the ability to support your team during high demand and deadlines

Our medical writers have the ability to absorb ideas of any complexity and translate them into language that is appropriate to your target audience. As a TEAM we are also adept at producing a compelling business case to effectively convey your argument to the regulators, using accuracy and attention to detail.

Looking for some help and guidance? Get in touch and our medical writing team can quickly see how we can help and explore your requirements – we welcome the opportunity to offer our expertise. Just call +44 (0) 1476 512395 or email info@puredrugsafety.com

Our expertise and experience promise

  • Scientifically/medically qualified writers
  • Broad experience of company and market types
  • Qualified in Pharmacovigilance (PV)
  • Qualified in Regulatory Affairs (RA)
  • Fully ABPI, ICH and GVP aware and compliant
  • Delivery of high quality tailored projects

You can trust the PDS medical writing team – we care about your projects, the quality of our work and delivering to meet your needs and objectives. When you outsource medical writing projects to PDS, you really can leave them to us to manage; we will deliver what you need, when you need it.

PDS can support you with any size of project for any audience: from full-scale clinical development plans, investigator brochures or product monographs to patient information materials.

Our writing expertise covers

  • Regulatory submissions
  • Licence maintenance documents
  • Clinical Study Protocols
  • Investigator Brochures
  • Clinical Study Reports
  • Patient Narratives
  • Risk Management Plans
  • Annual Safety Reports (ASRs)
  • Periodic Safety Update Reports (PSURs)
  • Pharmacovigilance system
  • Pharmacovigilance process documents
  • Summaries of Product Characteristics (SmPC)
  • Package leaflets and labelling
  • Patient support information

Glossary of Terms

IMRAD : An acronym that represents the organizational structure frequently used in research reports: Introduction, Methods, Results, and Discussion.

MEDLINE (Medical Literature, Analysis, and Retrieval System Online) : The U.S. National Library of Medicine’s (NLM) leading bibliographic database.

MeSH (Medical Subject Headings) : The U.S. National Library of Medicine’s controlled vocabulary resource.

Meta-analysis : A method of combining the results of several studies into a summary conclusion, using quantitative strategies that will allow consideration of data in diverse research reports.

PubMed : A Web site that is a service of the National Library of Medicine, with more than 14 million citations for biomedical articles from MEDLINE and other sources.

PBRER : Periodic Benefit-Risk Evaluation Report

PSUR : Periodic Safety Update Report

DSUR : Development Safety Update Report

PIL : Patient Information Leaflet

RMP : Risk Management Plan

Talk to us

Whatever your medical writing and/or communication needs, we aim to meet your expectations. Please Contact us to discuss and explore your requirements – we welcome the opportunity to offer our expertise.