Alchemy Medical Writing
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Alchemy Deep-Dive: Clinical study reports
Alchemy Deep-Dive: Clinical study reports
A Clinical Study Report (CSR) is a highly technical document that provides a detailed account of the conduct and outcomes of a clinical trial. These reports play a crucial role in enabling the development and approval of new drugs and medical devices, facilitating future research, and ultimately, improving patient care.
Alchemy Deep-Dive: Development safety update reports
Alchemy Deep-Dive: Development safety update reports
A DSUR is a safety document that is submitted annually for investigational drugs. The DSUR is a comprehensive document that details all of the safety data collected during the clinical development of an investigational drug. These reports play a key role in the evolving safety profile of an investigational drug, and facilitate sponsors, regulators, and stakeholders to make appropriate risk assessments and decisions over the course of an investigational drug’s clinical development lifecycle.
Alchemy Deep-Dive: Literature Reviews
Alchemy Deep-Dive: Literature Reviews
It a nutshell, a literature review is a comprehensive, critical analysis of existing academic work on a specific topic or research question. It does not merely list and describe sources, but rather, it critically examines the literature to uncover gaps, contradictions, and opportunities for further investigation.
Alchemy Deep-Dive: Patient Narratives
Alchemy Deep-Dive: Patient Narratives
Patient narratives must be included as a required part of Clinical Study Reports (CSR) for narrative?triggering adverse event types defined by the International Council for Harmonisation (ICH). These narratives should succinctly describe pertinent safety events experienced by participants in a clinical trial.
Crafting an Investigator’s Brochure for a Biopharmaceutical Company
Crafting an Investigator’s Brochure for a Biopharmaceutical Company
Safety, accuracy, and compliance are always top of our agenda. And nowhere is that more important than when crafting an Investigator’s Brochure. This key document is essential in drug development, providing in-depth data to support investigators with their understanding of the investigational treatment. Read on to discover how we partnered with a leading biopharmaceutical company with teams in the US and Europe to help create this significant document…
Spotlight On: Study Reports
Spotlight On: Study Reports
Understanding the key differences between how a study reports information for medicines and medical devices is crucial for professionals navigating the healthcare sector. These two brackets, which ensure patient care, follow distinct and unique developmental strategies, and have different regulatory requirements and evaluation criteria. This blog delves into the key differences, shedding a light on how study reports for medicines and medical devices are tailored to their own fields.
Spotlight On: Refining a Manuscript for Lancet Respiratory Medicine
Spotlight On: Refining a Manuscript for Lancet Respiratory Medicine
We recently had the privilege of supporting a global clinical-stage biopharmaceutical company with their submission to Lancet Respiratory Medicine.The publication reported the pivotal trial results from a Phase 3 randomised controlled trial in patients with non-small-cell lung cancer. Here’s how we did it…
Spotlight on: On-Site Congress Support
Spotlight on: On-Site Congress Support
Medical congresses mark key milestones throughout the MedComms calendar. These congresses are a perfect opportunity to present new data and educate audiences on specific therapy areas or treatments. Medical writers play many roles at congresses, from content development for abstracts, posters and slide decks, to on-site reporting of key data.Last month, we were asked to attend a European congress on bone health and report on the data of interest presented.
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Our Website
Dynamic healthcare communications. We are a straight-talking, personable, highly specialised medical writing agency with transparent, ethical processes, and a true ethos of inclusion and diversity.
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