We provide a wide range of medical writing & related services and offer solutions tailored to your specific needs.
Writing documents and presenting data in a clear and well-structured manner is Emtex’ core competence. Our skilled team members are flexible and proactive and take ownership of your needs from beginning to end to guarantee success.
Our medical writing and related services are grouped into 4 domains. An overview of the most common services within each domain is provided below. We can offer more services and solutions besides those listed below. Contact us to learn more about our services and how we can meet the specific requirements and needs of your company.
Over the years, we have gained extensive experience in the presentation and interpretation of data into well-structured, clear scientific documents. Emtex has contributed to several successful submission dossiers. We can support your company in the preparation of the documentation needed to speed up the development processes on the way to regulatory submission and approval. An overview of the most common regulatory medical writing services is provided here.
Clinical Study Report (including narratives) (CSR)
The Clinical Study Report (CSR) is a crucial document in the drug development and regulatory submission process. It is an integrated report of a clinical study of any therapeutic, prophylactic or diagnostic agent in which the clinical and statistical description, presentations and analyses of the study are provided in a single report, incorporating tables and figures into the main text of the report and in appendices. In essence, it compiles all results of a clinical study. To ensure prompt delivery of high-quality CSRs, a medical writer needs to both understand regulatory requirements and have the ability to decode the many aspects of the project knowledgebase.
For human pharmaceuticals, CSRs should be compliant with the International Council on Harmonization (ICH) E3 Guideline: Structure and Content of Clinical Study Reports. Following this guideline, a CSR should contain narratives for deaths, serious adverse events, discontinuations from study drug and other adverse events of interest.
A narrative can be defined as a summary or synopsis of the event that has occurred to a subject participating in the clinical study. The narrative must mention the subject ID of the patient, ethnicity and medical history of the patient, the reason why the study treatment was given to the subject, a detailed version of the medical event that has occurred, what action was taken after the event, a description if the event is related to the study drug or otherwise and a list of all vital signs of the subject. If there is any other notion considered important by the Principal Investigator or delegate, it should be mentioned in the narrative as well.
We offer research & insights services for customers who want to dive deeper into specific domains of their choice or who want to get a better understanding of their data through statistics, graphics or dashboards.
Data collection can occur via our Online Panel Survey or Life Focus Groups, which allows to gather further insights and generate new ideas based on direct feedback.
Data can be analyzed and transformed into graphics or dashboards to aid in the interpretation and communication. Statistical expertise & support is available to ensure the best possible results.
We can provide media & communications services fitted to your audience (general or professional) in the desired format such as written, audiovisual, oral or online materials and many others. An overview of the most common media & communication services:
Our professionals have developed several training sessions for medical writers. We can also offer tailored courses for medical writers adapted to your specific training needs. It can take place in our facilities, your company, other location, or even online. Our trainers are professionals with sufficient experience in the field.