Type: Publications

AI and automation are both exciting and daunting prospects in the future of medical writing, but the advantages of these tools should be scrutinised, as well as what they mean...

In light of recent regulations, it is important to discuss the general aspects and strategies for writing and compiling a CER. In Europe, a clinical evaluation report (CER) is now...

Process optimisation and effective management and organisation strategies are essential components when preparing CTD submission dossiers for drug approval. “Be prepared.” In his book, Scouting for Boys, Robert Baden-Powell introduced...

EMA Policy 0070 requires the publishing of all clinical reports submitted as part of MAAs, so it is important to highlight what new challenges this may bring for the writing...

In any industry, there is considerable evidence of the value and improved productivity for those who maintain a healthy work-life balance, and we should not forget that a near total...

The second edition of Trilogy’s special edition magazine, Medical Writing – A Bold New Path: The Future Awaits Us, was published at the beginning of 2020. Once again, Trilogy Writing...

The most recent changes to regulatory legislation in terms of information for patients – the introduction of the lay summary of the risk management plan (RMP) and the lay summary of clinical trial results (CTRs) – have caused great discussion and concern in an industry very willing to provide information to patients, but more used to producing complex scientific information for regulatory authorities (RAs).

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.