dinox GmbH

Tanja Rautenberg, Medical Director at dinox, sent the article 'Kids of Working Mums Grow into Happy Adults' by Kathleen McGinn to our colleague Aranka Bene, who works as a study coordinator, and asked her: "Aranka, as a working mum, I recommend you to read this article I stumbled across on LinkedIn.”   After reading the article, Aranka responded with the following:   "I read the article and was personally touched by it, because as a working mother of two children at dinox, I have experienced how important a supportive working environment is to fulfil exactly these points. The flexibility at dinox allows me to successfully balance work and family life. My children benefit enormously from this: they develop self-confidence, strength and a modern understanding of gender roles. At dinox, we work in a respectful and collegial community that supports working parents. Our research in women's health is not only professionally fulfilling, but also personally meaningful. My children look to me as a role model, showing them that women can be successful and independent while learning the importance of women's health. Experience has taught me that working mothers make a valuable contribution to both the world of work and the world of family".   Thank you Aranka for choosing dinox GmbH as your employer after the birth of your first child and for being such a dedicated part of our dinox family ever since! Behind every company there is a network of employees and behind every employee there is a network of families 💞 - it is important to us to always keep this in mind.

Since our Dutch colleagues 🧡 joined the Berlin team in 2017, we have had the tradition of Toastie Monday. The start of a new week is much easier when you celebrate it with a colourful meal together. The leftovers often last for days. That's why it was a good idea for us to switch from the original Toastie Friday to Toastie Monday. Although a little energy boost at the end of the working week was also nice. Do you have a special Team-Lunch-Day? Have a great new week everyone!

We have been waiting for this news: the new Medical Research Act (Medizinforschungsgesetz) is now in force!    Above all, we are pleased about all the innovations that will speed up the authorisation and implementation of clinical trials in Germany, such as ▶ Specialisation of ethics committees ▶ shorter approval periods for monocentric studies ▶ single-gate approach for trial notification procedure under radiation protection law ▶ Binding standard contract clauses In close cooperation with Europe, we can thus bring the European Regulation EU 536/2014 to life. However, we also see personal opportunities, because after the approval of a new drug, there is room for price negotiations if at least five per cent of all study participants in the approval studies took part in German study centres. We see this as recognition of our high quality standards in Germany. We are therefore starting the new week and the second half of the year with great prospects.

the pearls of contraception? The Pearl Index is a calculation method used to describe the effectiveness of contraceptives. It has nothing to do with pearls, but is derived from the inventor of this calculation method, Raymond Pearl. He made a name for himself with this method, a name which is still used today for studies which determine the contraceptive effectiveness of a new contraceptive: a Pearl Index Study. Well done! and our recent pearl index study? well done as well!

As promised, here are some more insights into a Pearl Index study that we conducted with inne: inne MINILAB Effectiveness Study for Contraceptive Use   For dinox, this was a unique clinical study outside of our usual product range, but absolutely in line with our passion: Clinical research for women and, as in this case, their needs in terms of safe contraception!   We conducted the study with 300 committed women from all over Germany from April 2022 to May 2023. We thank all participants for their contribution to this success! The results are currently only available as a lay summary on our website (https://lnkd.in/dtxkA8X3) and are therefore in the German language.   It is a scientific standard to describe the contraceptive effectiveness of a product using the Pearl Index. This analyses how many women out of 100 who use a contraceptive method for 1 year become pregnant during that year. The Pearl Index is calculated on the one hand for typical use (typische Anwendung), which includes all pregnancies, even if the method was used incorrectly. On the other hand, perfect use (perfekte Anwendung) is taken into account, i.e. only those pregnancies are included in which no application error occurred. The results for the MINILAB are excellent, even compared with other contraceptive methods. However, our study only looked at a total of 113 woman-years, which corresponds to 1467 menstrual cycles. A Pearl Index study with a hormonal contraceptive usually uses 10,000 menstrual cycles (1).   (1) https://lnkd.in/dDaaYc8C

ANYTHING NEW NEEDED? dinox has specialized in conducting clinical trials in the fertile population for 30 years. During this time, many hormonal contraceptives have been developed in collaboration with our in-house dinox experts Christine Klipping and Ingrid Duijkers who have developed the most appropriate study designs. In addition, the whole dinox team sometimes likes to think outside the box. Therefore, we were very interested in conducting a clinical trial without hormonal treatment, but with a medical contraceptive device. Stay tuned! You or the women around you may be wondering: do we need new hormonal or hormone-free contraceptive? The answer could be yes! There is still room for improvement across the contraceptive spectrum. We are excited to see what the future holds.   If you are planning a women's health study or would like to brainstorm about future women's health studies, please contact us via LinkedIn or email to discuss how dinox can help you design and conduct your upcoming study. https://lnkd.in/e6fwXXH9

The 5th edition of the „Leitfaden Klinische Prüfungen von Arzneimitteln und Medizinprodukte“/ "Guide to Clinical Trials for Medicinal Products and Medical Devices" has arrived at dinox. We are pleased to be able to use this revised and expanded edition as a reference and to re-evaluate our established operational management for the preparation, implementation and evaluation of our projects. The field of clinical trials is very broad and we are specialized in outpatient clinical trials of phases I to III. The whole dinox team is looking forward to browsing through the book and not only getting a confirmation of the existing knowledge, but also to think outside the box.

We very much enjoyed attending the AGAH e. V. annual meeting last week. As usual, it was an inspiring event with great presentations, great speakers and interesting topics. In the session on digitalisation in clinical development, our Medical Director Tanja Rautenberg had the opportunity to present our experience with a virtual clinical trial together with Annika Dax and Stephan Herrmann from SocraTec R&D/SocraMetrics and Martin Coenen from the University Hospital in Bonn. Our CEO Christine Klipping presented the inclusion of women of childbearing age and healthy volunteers with a high BMI in clinical trials, which led to a lively discussion. And of course it was very nice to see colleagues from other companies again and we are looking forward to the next AGAH meeting!  

Today, on World Health Day, we would like to draw attention to the fact that around 20% of women in Germany are affected by hair loss.¹ This number increases with the first symptoms of the menopause, as hair loss is one of the most common symptoms, along with hot flushes and sweating. The psychosocial impact of hair loss is underestimated and the quality of life of those affected is severely compromised.² Hair is associated with femininity, beauty and identity. Lack of hair, on the other hand, is associated with disease and, historically, with humiliation and oppression.¹ This contributes to the fact that women are more likely than men to be stigmatised and that women increasingly try to hide their hair loss.² Dinox wants to make an active contribution to helping women affected. We are currently recruiting women with female pattern hair loss for a 6-month outpatient study in Berlin. Please visit our website at www.dinox.de ¹https://lnkd.in/d_gzSs4t ²Maximilian Christian Schielein, Linda Tizek, Stefanie Ziehfreund, Rachel Sommer, Tilo Biedermann, Alexander Zink: Stigmatisierung durch Haarausfall – eine systematische Literaturübersicht, JDDG: Journal der Deutschen Dermatologischen Gesellschaft, Volume 18, Issue 12, Dezember 2020, Seite 1357-1369

Easter time - everything revolves around Easter eggs.   At dinox, we deal with "eggs" all year round, namely female egg cells. Females are born with approximately 1-2 million of their own egg cells, which remain dormant in the ovaries until puberty. Then, with the help of complex hormonal regulation, the eggs are brought to maturity step by step, cycle by cycle. At ovulation, the mature egg leaves the ovary and is ready to be fertilised. A new life is on its way. Whenever you enjoy or work with eggs at Easter time, remember this miracle of fertility - hidden in the female body. Happy Easter to all!