4Pharma - Beyond Your Data

Medical Writing


Medical Writing

Medical writing is a fundamental component of clinical research. Our proficient medical writers collaborate seamlessly with teammates from project management, data management, biostatistics and quality assurance to provide you with documents to the highest industry standards.

Our medical writers become a natural extension of your team by bringing real synergies to your project work and committing to the project milestones. We have in-depth knowledge on pharmaceutical industry and clinical research, but we are equally comfortable with pharmacokinetic, pharmacodynamic and epidemiologic assignments.

By our data visualization capability, we combine science and art and help you communicate a quantitative message in a compelling manner.

Our medical writing services include clinical and regulatory writing, as well as scientific papers, education material and medical writing consultancy. Examples include:

Clinical and Regulatory Writing:

  • ICH compliant clinical study reports (CSRs; Phase I to IV including pediatric)
  • NI-PASS compliant CSRs
  • Study protocols, amendments, and administrative changes
  • Regulatory documents (e.g., briefing books, summaries, overviews)
  • Investigator brochures
  • Patient information/consent documents and narratives
  • Standard operating procedures (SOPs)

Scientific and Educational writing:

  • Manuscripts
  • Conference abstracts (posters and slide sets)
  • Medical marketing reviews and reports
  • Promotional and educational material

Appraisals of 4Pharma Medical Writing team by our customers

“Since the early 2000s, we have been working with 4Pharma’s medical writing team while developing our proprietary products. We sought a team that would not only be experienced in our core therapeutic area, but would also have expertise in clinical studies, drug development, and regulatory strategy. We found all this, and more, in 4Pharma. The team has helped us design clinical protocols and evaluate our clinical results, written over two dozen ICH compliant CSRs for our various projects, and even joined with us at FDA and European regulatory meetings”

“The draft CSR was very well written, I believe the next version should be the penultimate version and we can move quickly to a final CSR”

“Without doubt this milestone could not have been achieved without the exceptional teamwork, as well as passion and dedication, shown by the team. Thank you for being an important part of this team”

“This exemplary effort not only achieved internal objectives but will allow this important and innovative product to become available to patients as soon as possible”

Our assignments span over the whole range of study phases and various therapeutic areas, such as CNS, ophthalmology, women’s health, rheumatology, antibiotics and many more. Examples include:

THERAPEUTIC AREA

STUDY PHASE/TYPE

STUDY
DESCRIPTION

STUDY
YEAR

Women’s health

I

In vitro-in vivo

Various CSRs (PubMed)

2010-13

Ophthalmology

III

Overview

Publication (PubMed)

2014

Rheumatology

IV

Observational

NI-PASS CSR

2015

Ophthalmology

III

Pre-NDA

FDA briefing book

2016

Ophthalmology

IIIb

Switch

ICH CSR (PubMed)

2016-17

CNS (Parkinson)

I-II

Adaptive

ICH CSR

2017

CNS (parkinson)

II

Full QTC

ICH CSR

2018

Antibiotics

III

Pivotal

Study protocol

ongoing

 

Want to know more?

Contact our specialist directly, we gladly answer your question.

Jouni Vuorinen, PhD, Adjunct Professor , Chief Scientific Officer