Software-based medical writing
We can support you throughout the entire process of producing your medical texts. Or we can take on individual tasks upon request. Our main priority is to help make your texts more effective and reader-friendly.
Send us your finished documents, your rough drafts, or a text briefing. We will analyse your text and give you detailed advice on how to improve it. We can also optimise your text for you and transform it into lay language. Of course, we adhere to regulatory requirements. If needed we can also translate your documents into all EU languages. Reader testing, benchmark development and workshops are part of our services, too.
- We analyse your text and give revision advice.
- We optimise your final text or write your documents for you.
- We transform your specialised text into lay language.
- We translate your documents into all EU languages.
- We adhere to regulatory requirements.
- We track and update your terminology bank.
- We test your texts on your target group.
- We develop standards and benchmarks for your communication.
- We train you and your employees to use tools to efficiently manage your own language.
Reporting information from clinical trials is a long and complex process, and we can offer you support.
Our team of experienced medical writers, linguists, and experts in regulatory compliance is committed to high-quality language and understands the regulatory process. We work according to country-specific templates, terminology, formatting and special guidelines.
In the early stages, we can create or finish your:
- Clinical trial reports
Later in the publishing process, we can also produce:
- Package Leaflets
In order to meet regulatory compliance guidelines for all managed SOP processes, we adhere to requirements from EDQM, MedDRA, the QRD Group, the EMA and the CHMP. Along with checklists, we develop individual software for this purpose (for instance, our method to test the QRD convention required by the EMA-QRD template).
High-quality, specialised editing and a commitment to meet the requirements of health authorities ensures that your content is acceptable to regulatory authorities. That holds true especially for translations, regardless of whether the text is specialised or lay-friendly.
We make it simple. We translate your medical texts into lay language. We work within all relevant medical and regulatory framework. Our highly-trained interdisciplinary team has many years of experience to deliver top quality.
We work with these documents:
- Clinical trial synopses
- Lay summaries
- Subject / Patient Consent Forms
- Risk Management Plans
- Package Leaflets
We help to optimise:
- Subject/Patient surveys for clinical studies
- Informative materials for patients (brochures, journals, etc.)
We tailor each document to fit the following regulatory requirements as applicable: QRD templates, Guideline on The Readability Of The Labelling And Package Leaflet Of Medicinal Products For Human Use, Glossary (In Lay Terms) For Use In Preparing Consent Forms For Human Subjects, Glossary Of Medical Terms In Lay Language (MHRA) etc.
Our promise: We create your medical content to maximise your readers’ understanding.
The international health care arena demands clear communication, despite language barriers. Especially as more lay documents become public, careful attention to comprehensibility becomes more important. We appreciate the complexity involved in these translations.
That’s why our start-to-finish methods include translations for both specialized medical and lay texts. We accompany you throughout the process according to your work flow, from early drafting through to the final text in each target language, ensuring consistent high quality.
We work with our partner, LangCor Service GmbH, on translating your specialised medical information into all EU languages. Native speakers from each target country ensure clarity. Of course, we adhere to all regulatory obligations from each target country.
Our translations include, but are not limited to:
- Summaries of Clinical Trials for lay readers
- SmPC/PL and Labelling documents that conform to QRD templates
- Subject/ Patient Consent Form
Our software allows for immediate, objective comparison of readability between text written in English and German.