Type: Publications

For years, the clinical drug development industry has been waging war against the surging drug development costs and tediously long processes. More efficient decision making during drug development would be...

In 2014, as part of its Clinical Trial Transparency initiative, the EMA mandated a requirement (CTR EU No 536/2014) for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (plain language) no later than one year after the end of the trial in the EU. These CTR lay summaries will be made available in a new EU database; it was planned for 2018, but it is likely that it will not now be implemented before 2020.

We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers and the pharmaceutical industry as a whole in trying to comply with recent European requirements for the creation of lay summaries of key regulatory submission documents.

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of biological molecules, not full “sameness”.

Julia Forjanic Klapproth of Trilogy Writing & Consulting GmbH elucidates how it’s time to start using strategic medical writing in the world of device submissions. Until recently, the documents needed...

This article discusses the challenges of producing a periodic benefit–risk evaluation report (PBRER) from a writing perspective. It explains that by taking into consideration the most common pitfalls encountered by...

Everyone involved in preparing regulatory documentation in the pharmaceutical industry is always on a desperate look out for excellent medical writers with years of experience writing the documents they need....

Review is an integral part of the medical writing process and relies on clear communication between the medical writer and the reviewer(s). This is a two-way street. Review can be...

Quality control (QC) is a process that usually occurs when a document is in a near-final or final state. It involves the checking of documents by QC specialists against source...

An initial Pediatric Study Plan (iPSP) is an outline of the paediatric study or studies that the drug development sponsor plans to conduct in the US to confirm the suitability...

Gerry McGregor, a principal medical writer at Trilogy Writing & Consulting, explains how experienced medical writers can help medical device manufacturers to meet the new regulatory demands of producing clinical...

In recent years, the robustness and reproducibility of preclinical data have been a topic for discussion. Quality standards and good practices are often not well defined for different in vitro...

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in the pharmaceutical industry). The regulation (CTR EU No 536/2014) obliges the company to produce this summary of results for the lay audience one year after the end of the trial in the EU.

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be...

Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, explains how to prepare good requests for information and proposals in the field of medical writing. If you have ever been...

Pharmacovigilance is a critical element of drug development and marketing. The evaluation and monitoring of patient safety and a drug’s benefit/risk is a highly regulated global task, which is required...

The Common Technical Document is an international standard for the summary documents needed to obtain regulatory approval of medicinal products. These summary documents involve presenting key information drawn from a...

This special edition is meant to increase the general awareness of the need for good documentation on the one hand and to provide good medical writing practices and tricks of the trade on the other hand. It is intended to have lasting value as a reference book for the target audience – medical writers and everyone in the pharmaceutical industry working with medical writers.

Recent pharma initiatives have been established to help ensure that clinical study protocols and reports are always presented in a similar way, making for easier assimilation and assessment. This article...

Clinical development is a complex and expensive undertaking, involving many years of research that culminate with clinical trials, the objectives and results of which all have to be documented. This...