Medical Writing Biotechnology Overcoming confidential information challenges faced by study sponsors today
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Volume 32, Issue 4 - Biotechnology

Overcoming confidential information challenges faced by study sponsors today

Abstract

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which contain sensitive and confidential information about company intellectual property including, but not limited to, its manufacturing methods, drug composition, names of suppliers, and future development plans. Many manufacturers are examining their processes to minimise references to this confidential data during the document authoring process and how they track and identify confidential information throughout the study lifecycle. This has created a catalyst for medical writing, transparency, legal, and regulatory teams to collaborate and enhance their processes to minimise disruption to the trial approval process while embracing the opportunities to share more with the public.

Medical Writing. 2023;32(4):20–22. https://doi.org/10.56012/rjfu6501

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Articles

Medical Writing explores the many faces of Biotechnology
From the Editor
President's Message
EMWA News
Biomanufacturing and One Health
Five questions for Ruggero Galici on nonclinical medical writing
Overcoming confidential information challenges faced by study sponsors today
Living medicine: The story of CAR T cell therapy
Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin
The evolution of biotechnology: From ancient civilisations to modern day
Advances in the CRISPR-Cas9 system and gene therapy
Harold Swanberg, MD: Why and how EMWA should remember him
How to get your writing found: Why medical writers and academics need to use search engine optimisation
In vitro plants: How to open a jar containing bioactive phytochemicals
News from the EMA
Digital Communication
Medical Communications and Writing for Patients
Veterinary Medical Writing
Regulatory Matters
Good Writing Practice
The Crofter: Sustainable Communications

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Tiziana von Bruchhausen

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Clare ChangZuo Yen Lee 

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Sam Hamilton

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Claire Gudex

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