Services

Services and solutions offering

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.

 

How can we  help you?

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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.

Contact us for other document types not listed.

Investigator’s Brochure (IB)

The Investigator’s Brochure (IB) is a comprehensive document summarizing the body of information about an investigational medicinal product (or study drug) obtained during drug development. The IB is a document of critical importance throughout the drug development process and is at least annually updated with new information as it becomes available. The document provides the clinical investigator and others involved in clinical studies all information to facilitate their understanding of the rationale for the study and their compliance with key features of the study protocol (e.g. dose, dose frequency, methods of administration and safety monitoring). The IB therefore compiles all data relevant to studies of the investigational product in subjects gathered during preclinical and other clinical studies.

For medical devices, the IB contains the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Updates to the IB, generated when new relevant information becomes available, should be provided to the investigators in a timely manner. Requirements for the IB are detailed in Annex XV (Chapter II, Section 2) of the Medical Devices Regulation (2017/745).

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.

 

Contact us to discuss your needs!

Great things in business are never done by one person.
They’re done by a team of people.

Steve Jobs

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