Medical Writing

Excellence in Medical Writing Lies in a Passion for Precision

Our medical writers have extensive experience in development of various documents for all therapeutic areas. All our medical writing activities follow structured processes that ensure content accuracy, regulatory compliance, and your desired visual and structural specifications.

We develop or can support development of various documents and materials with a deep understanding and consideration of the intended use and reader of each deliverable. Our portfolio of medical writing deliverables include, but are not limited to:

Informed Consent Forms

Our dedicated process for ICF development has been carefully crafted for full compliance with ICH-GCP, and the EU Clinical Trial Regulation
All ICFs developed by us are rigorously reviewed approved by our legal expert and Data Protection Officer to ensure that all language concerning personal data protection is in accordance with GDPR
We have a deep understanding of the Clinical Trial Protocol and Investigator’s Brochure to ensure all required and important trial information is described at the appropriate reading level of the trial population
Our team will work closely with you to ensure that your requirements for ICF content and design are incorporated in the most optimal manner
We work closely with our Regulatory and Clinical teams, to oversee the translation and submission of country adapted ICFs

Throughout the entire life cycle of initial ICF creation and update throughout the study, our team will always put the patient first, to ensure that the language is not overly complicated and potentially overwhelming for the reader’s understanding

Lay Summaries

Under the EU Clinical Trial Regulation (Regulation (EU) No. 536/2014, Article 37), trial sponsors are required to develop and submit a lay summary into the public EU Database of the EU Clinical Trials Information System (CTIS). These lay summaries must be understandable to people with limited medical or clinical knowledge and must contain an overview of the study and study results. Lay summaries must be submitted after the end of the clinical trial as defined in the protocol, within 6 months for paediatric studies and 12 months for adult studies.

We recognize the importance of increasing transparency of clinical trial results with the affected patient populations, healthcare professionals and by extension, the general population
Our thoughtfully structured process ensures the timely creation, review, translation, visual development, and dissemination of lay summaries to comply with the publication deadlines defined in the EU Clinical Trial Regulation for clinical trials performed in the EU
Our team will take great pride in constructing simple-to-read and visually appealing summaries of the clinical trial results
We can also provide guidance and support for optimal methods of dissemination of lay summaries

Writing for Recruitment, Retention and Patient and Site Support

Meeting recruitment targets and retention of clinical trial participants can often be a challenge. We can provide additional support through development of tailored materials for both patients and sites
We offer a standard set of materials for patients and sites, including but not limited to posters, brochures, physician referral letters, study guides, reminder cards, eligibility criteria checklists, and diaries
We can also provide recommendations for bespoke materials based on our assessment of possible areas for support, based on our deep understanding of the trial population and therapeutic area
The visual specifications of documents play a key role in increasing engagement of the intended reader. Our team will pay attention to every detail, including identifying the best font style, size, line-spacing, use of visual cues and infographics to support reader engagement and comprehension

We will work closely with you at every stage of the clinical trial, to create materials to help you meet your recruitment and retention needs!

Core Study Documents

Do you need support with writing the clinical trial protocol, IB, IMPD, or CSR? We are here to help! Our medical writing team is ready to provide guidance and perform review of new or updated core study documents. During both initial development and update of core study documents, we will work closely with experts in our various departments to provide highly quality input and feedback to all sections of each document.

Medical Writing Expertise and Guidance

If you are looking for medical writing expertise, we can also provide medical writing consultancy services to support with accuracy of contents, regulatory compliance, quality of language and general structural and visual specifications.