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.

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​.

Sample Size

Sample size calculations are needed to determine how many subjects should be enrolled in the clinical study. The statistician starts from a list of assumptions such as the required levels of the type-I and type-II errors, the study design, and the size of the treatment effect with some estimate of its variability. It is not just a calculation, but rather an in-depth team discussion about these assumptions. Especially the assumed treatment effect requires team input. Typically the statistician will perform a whole series of calculations, including what-if scenarios to find out how sensitive the calculations are to the assumptions made.

Sample size calculations are not an exact science. Formulae and computerized systems are used for the calculations, but always there are uncertainties and strong assumptions. It is in these circumstances that the statistician will present more than just sets of numbers, but will trigger the necessary discussions to find out how realistic the assumptions actually are. This is crucial. It unfortunately happens that a clinical study turn out inconclusive simply because of unrealistic assumptions.

The Emtex statistician has over 25 years of experience in sample size discussions.

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!

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Customer testimonial:

 

“Experienced and proactive medical writers. The writers exchange and update each other across documents and projects so that they use the latest processes, ways of working and company preferences. I’m impressed by their consistent quality and attention to detail.”

Associate Director Medical Writing

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