November 2020

#covid-19

Clinical Studies in Times of Covid-19

Different procedure, same offer

The rising incidence rates everywhere are a good reason to let you know about our current study capacities. The good news first: We continue to perform studies and can offer nearly all study types provided in the past. There are only a few cases in which we have suspended studies, such as those examining halitosis, because there is no way to reconcile these procedures with our hygiene concept.

But at the same time, we are far away from normal, pre-pandemic operation. The hygiene and protective measures that we have implemented have too great an impact on the way in which we conduct our studies.
Social distancing is a good example of the restrictions with which we are dealing. Before the pandemic, there was no limit on how many people could be in an exam room. We were able to organize work flows such that e.g. multiple stations were set up in one room, allowing several test persons to be examined at the same time. Our safety and hygiene concept specifies that, in the current situation, only a certain number of people can be in a room at the same time, the limit being a factor of the size of the room. Depending on the type of study, contact restrictions may force changes to the usual study procedures.

Before the pandemic, our test persons benefited from sharing their experiences with others taking part in the study. But now they have to comply with social distancing rules. So we plan our studies such that contact between test persons is minimized. This impacts scheduling and, consequently, how long it takes to complete a study.

These are just two examples of the changes to the current procedures and performance of studies implemented as a result of our hygiene concept. The intention is to protect the health of our employees and test persons while still ensuring that studies can continue. Despite all the changes we have been forced to implement as a result of the pandemic, we are still able to offer our customers a wide range of studies.

You can find a summary of our hygiene concept on our website. Go to the FAQ section for answers to relevant questions related to the topic of “Studies and Covid-19.

Covid-19 Measurements

#virtualtour

Visit proDERM

Virtual tour of our ‘Solaris’ unit

Business travel is more difficult in times of Covid-19 and is reduced to a necessary minimum for security reasons. Hence, many of our customers are not able to get a personal impression of our examination rooms. Therefore proDERM comes to you.

From now on, we will provide you with a virtual tour of our examination units. At the beginning, we will guide you through our ‘Solaris’ unit, which is dedicated to conducting studies on the topics of tolerability, pollution, sun protection, as well as antiperspirants and deodorants. We plan to continue the virtual tour in the other units. As soon as this is completed, we will inform you accordingly. We look forward to welcoming you.

#medicaldevices

Risk classification of medical devices

proDERM guideline improves transparency in the set of MDR rules

On May 26, 2021, Regulation (EU) 2017/745 on medical devices (Medical Device Regulation, MDR) comes into force simultaneously in all EU member states. This will result in significant changes with regard to the market approval of medical devices. Among other things, the MDR changes the allocation of a medical device to a risk class with new or changed regulations.

We have prepared a guideline that is intended to support manufacturers in assigning medical devices to a risk class. It is a translation of the rather non-transparent set of rules (Annex VIII of the MDR) into a simplified form, on the basis of which a category-specific classification can be made.

You can access the guide via the following link.

Risk Classes of Medical Devices – the proDERM Guide

#recruitment

Opening of the proDERM InfoPoint

Test phase runs until April 2021

On November 2, 2020, we opened a new information center for study participants at our main location in the shopping center in Schenefeld on a trial basis: the proDERM InfoPoint. The shopping center is frequented by approximately 20,000 visitors daily and we would like to find out to what extent the increased presence due to the InfoPoint is helpful for successful recruitment of study participants.

The test phase is scheduled for 6 months. We have rented a space directly at the main entrance of the shopping center and equipped it with two information areas and a dedicated room for interviews with new subjects. Volunteers can register for future studies directly on site, taking into account defined inclusion criteria, or, if suitable, be recruited for current projects.

After our units Luna, Sirius and Solaris, the InfoPoint is already the fourth area within the shopping center where we recruit test persons or conduct studies. You can have a look at our floor plan below:

#quality

Compliance with required standards

Confirmed by audits of DNV-GL and BVMA

Two independent audits were conducted at proDERM in September. On the one hand, the audits focused on the recertification of our management system according to ISO 9001:2015 by DNV-GL, a globally operating certification company. On the other hand, we were re-audited by the German Federal Association of Medical Contract Research Institutes (BVMA) with regard to compliance with the quality standards required by the association.
The main topic of the DNV-GL audit was the process of ‘report generation, dispatch and invoicing’. We were attested a high level of process control. The management system as a whole was considered effective and compliant with the standards. Therefore, the certificate issued to us, which confirms compliance with the requirements of ISO 9001:2015, remains valid.

The BVMA re-audit focused on the implementation of ICH GCP (R2) in general. A special focus was placed on risk management, quality management and data management.
Overall, the auditor’s report attests us a good organization and management. Although potentials for further optimization were identified in a few areas, we are pleased to report that, despite all the entrepreneurial dynamism, compliance with the GCP requirements for the conduct of clinical trials was independently confirmed.

#publication, #raman

Water and collagen in aging skin

New publication shows surprising results

In the field of cosmetics, scientific attention is mainly paid to the epidermis. Accordingly, there are a lot of studies on the epidermis, but comparatively few in vivo studies on the dermis. However, the dermis plays a key role in the youthful appearance of the skin, as the condition of the proteins, collagen and elastin it contains directly affects whether the skin is smooth or wrinkled.

Using Raman spectroscopy, we have studied both intrinsic and extrinsic skin aging processes, such as the well-known “photoaging” and the associated changes in collagen, using dermal water content intraindividually and in vivo.

These studies have yielded some surprising results, which we recently published in a paper in the Skin Research & Technology. You can access the publication via the Wiley Online Library.

In this context we would also like to congratulate Ghaith Kourbaj. Ghaith completed this work as part of his master’s degree with us and was awarded a prize by the SOFW.

#webinar, #dermalsafety

Phase 1 Studies for Evaluating the Dermal Safety of Topical Products

proDERM Webinar on November 19

This Webinar will provide an overview of required local tolerance studies. This includes methodological details as well as regulatory requirements.

While the local tolerance should be a prime concern for developing topical products successfully, this aspect is often neglected or addressed (too) late in the drug/medical device development. This webinar will provide a concise yet complete overview about required dermal safety studies and the respective protocol outlines, to evaluate cumulative irritation, contact sensitization, phototoxicity and photoallergy.

The webinar will take approximately 60 minutes and will end with a Q&A session. It will cover the following topics:

  • Concerns in testing of topical products
  • Guidelines
  • Objectives of dernal safety testing
  • Patch test systems
  • Clinical grading and scoring
  • Photographic scales
  • Interpretation of data
  • Cumulative Irritation Potential
  • Contact Sensitization
  • Phototoxicity