“Clinical Operations” at proDERM – What exactly is that and why should we talk about it? What distinguishes single-center from multi-center studies and how does this affect the organization and structure of proDERM? This update and those to follow will reveal the answers to these questions.
Our “Clinical Operations” department handles GCP studies with pharmaceuticals and medical devices. This is actually not new: We have been conducting such studies since 1995. But evolving conditions and the changing needs of our customers over the last two years have induced us to expand and restructure this area in view of being able to conduct multi-center studies.
One part of what we offer is the performance of single-center testing in the Clinical Research Unit at our headquarters in Schenefeld. When the study specifications require it, our team conducts multi-center studies that include an existing network of qualified testing centers throughout Germany, Austria and Switzerland.
The patients themselves are often the deciding factor when choosing the right scenario: When studies involve patients with acute diseases, we prefer to work with our network of external testing centers. Clinical studies of healthy test persons are generally best performed as single-center studies involving our Clinical Research Unit in Schenefeld.
This high degree of flexibility and adaptability is possible only when all of the organizational requirements are met to clearly differentiate the tasks allocated to the CRO from those of the Clinical Research Unit (Site). Our recent reorganization has made this possible: The “Clinical Operations” team operates as a self-sufficient CRO, managing and controlling proDERM’s own Clinical Research Unit (Site) and collaborating with other external testing centers when appropriate.
In the following ‘Update’ we would like to present our multi-center network of qualified study sites in more detail to you. Today we would like to focus on the introduction of our team:
Director Clinical Operations
In his 20+ occupational years in life sciences industry and CRO industry, Bernd held various positions such as Director Customer Relations, Director Clinical Operations, Senior Clinical Project Manager and Clinical Research Associate (CRA). He has successfully established Clinical Operation Teams and Clinical Project Management and he supervised CRAs as well as vendors in an international setting. He managed several multinational dermatological trials (i.e.: 1000 patients, 60 sites in Germany, Poland, UK) multicenter clinical trials phase II – IV – IMP (topical and systemic treatments – eg. Biologics TNF alpha inhibitor). Since 2018, Bernd works for proDERM, currently leading our Clinical Operations Team.
Head Project Management Clinical Operations
Angela has 10+ years of experience in contract research and life sciences industry. She started her career in 2007 as a Clinical Research Associate at proDERM before stepping into Project Management of clinical studies. As Head of Project Management Clinical Operations, she now oversees the overall management activities of the division. She has received trainings in a diverse range of topics such as GDPR in clinical studies, GCP, MDR, Non-interventional trials and more.
Lead Clinical Research Associate
David comes with 7+ years of experience as Clinical Research Associate (CRA) in different contract research organizations. He joined our team in 2019 and has been our Lead CRA since then. In this role his responsibility is to ensure qualification of staff and trial sites in multi-center settings. He is dedicated to quality and lives this mission in his daily cooperation with the sites to guarantee subject’s safety and data integrity for an excellent trial conduct.
Carolin is one of our newest team members. After receiving her Ph.D. at the University Clinic Eppendorf Hamburg, Carolin held several positions in medicinal research/medicinal industry. She has received additional trainings in ICH-GCP and MPG and she now supports the team as Project Manager.
Clinical Trial Assistant
Jana has held several research and scientist positions before joining proDERM in 2019. She has complemented her biochemical Ph.D. with further trainings in Project Management, Clinical Research and ICH-GCP. Jana knows exactly how to use these skills in her position as Clinical Trial Assistant.
Due to the technological advancements in photography, today even the most challenging cosmetic claims and product effects can be successfully examined and proven on the basis of photographic images and image analysis. In this webinar, we would like to immerse you in the world of claim support studies based on imaging methods. You will get an insight into the photography systems available at proDERM and the analysis options in claim support. In addition to commercially available systems, we will also demonstrate proDERM in-house developments. The webinar is hosted by Dr. Gunja Springmann, Head of Business Development, and Dr. Matthias Seise, specialist in image analysis; Head of Development and Technical Services.
The main focus will be to discuss imaging procedures and image analysis related to the the support of facial claims, hair care claims as well as other skin care claims. We plan to discuss the following:
Hair Care Claims:
Head Development and Technical Services
Head Business Development
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The claims support of oral care products is characterized by a number of special features. In this webinar we would like to present those features and our approaches for claims support solutions to you. Among other things, you should learn:
Business Development Manager
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Our seal “Dermatologically Approved” means that the products demonstrate particularly good skin compatibility. It can be licensed only if the results of the respective tests are at least “good.” This is a distinct differentiation from other “test seals” on the market. Our seal relaunch was followed quickly by the registration as an EU certification mark.
Per definition a certification mark is a mark that is “capable of distinguishing goods or services which are certified by the proprietor of the mark in respect of material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics, with the exception of geographical origin, from goods and services which are not so certified.” (Article 83(1) EUTMR).
Thus the ‘certification mark’ has been created explicitly for seals which now – in case they are registered as such – are protected when affixed to third-party (licensee) products. Before entering into or renewing a license agreement it might be useful for product developers to check trademark registers [i.e. eSearch plus] in order to get to know as to whether a seal is a certification mark or not. proDERM’s seal “Dermatologically Approved” can be found here.
Learn more about our quality seal ‘Dematologically Approved’. The brochure informs you about the concept of the seal and the requirements for licensing.
“A Dermonutrient Containing Special Collagen Peptides Improves Skin Structure and Function: A Randomized, Placebo-Controlled, Triple-Blind Trial Using Confocal Laser Scanning Microscopy on the Cosmetic Effects and Tolerance of a Drinkable Collagen Supplement” – this is the title of our publication that appeared in the most recent edition of the “Journal of Medicinal Food” as an Open Access article.
The aim of the study was to determine the cosmetic effects on skin quality of a food supplement enriched with collagen peptides. The study was designed to include the following key data:
Abstract der Publikation:
The purpose of this randomized, placebo-controlled, triple-blind trial on 60 healthy female volunteers was to assess the cosmetic effects on skin quality of a food supplement containing special collagen peptides together with acerola extract, vitamin C, vitamin E, biotin, and zinc after an intake of 12 weeks (Elasten®, QUIRIS Healthcare, Germany). To reduce assessment bias maximally and increase the accuracy and objectivity of the outcomes, the trial design was triple blinded in a manner that neither the subjects nor the person administering the products nor the person who assessed the primary outcomes knew which subjects had received the test product and which had received the placebo. The expert grader assessing the confocal laser scanning microscopy images was additionally blinded regarding the time when the image was taken (on days 1 or 85). The objective, blinded, and validated image analyses using confocal laser scanning microscopy showed a significant improvement of the collagen structure of facial skin (primary endpoint) after intake of the test product, while no improvements were found after intake of the placebo. The proven positive nutritional effect on the collagen structure was fully consistent with positive subjective evaluations of relevant skin parameters such as elasticity, crinkliness/wrinkliness, and evenness in different body areas such as face, hands, décolleté, neck, backside, legs, and belly, all serving as secondary endpoints. The test product was found to be safe and very well tolerated. A cosmetically relevant improvement of the facial skin was demonstrated after administration of the collagen supplement.
Where you can meet us in 2020
Please find below an outlook on our 2020 congress and trade fair participations. If you are planning to visit one of these events, we would be very happy to meet you there. You are welcome to make an appointment with us in advance. Please send an email to our Business Development Manager Ms. Kathrin Friedrichsen. Below you will find a complete overview of the business event participations currently planned.