To reach more patients across Europe, we're now a part of
The Borderline Personality Study: Oryzon has contracted emovis to be one of the sites in Oryzon’s sponsored clinical trial PORTICO testing Vafidemstat, the first ever epigenetic drug to specifically treat Borderline Personality Disorder (BPD). Given the severe negative effects for the disease, in combination with the lack of approved medicinal treatment options, emovis is excited and grateful to play its part in this study.
BPD affects around 2% of the population and its effects may be classed into four main areas; emotional instability (affective dysregulation), disturbed patterns of perception (cognitive distortions), impulsive behaviour and lastly intense, but unstable relationships with others.
BPD has severe negative and functionally debilitating impacts on those living with the disorder. About 60 - 70% of those diagnosed with BPD attempt suicide and around 20% of all female convicts are reported to have the disorder. Moreover, the disorder is one of the most expensive to manage for health care systems.
While psychotherapy has shown some effects in the treatment of BPD, no singular medication has been developed or approved to specifically treat BPD. Instead, off-label drugs, like antidepressants and mood stabilizers, that may help with symptoms or co-occurring problems, such as depression, anxiety and impulsiveness, are being used.
Given these limitations, emovis,contracted by Oryzon, is now testing the novel substance Vafidemstat (ORY-2001), an oral CNS optimised LSD1 inhibitor specifically for the treatment of BPD.
emovis commenced online recruitment in June 2022 with the help of Facebook and Google Ads as well as posters on subways and commuter trains. Our recruitment data shows that 1,577 interested people contacted us as a result of our marketing efforts(about 50 people per week), illustrating the high demand for BPD treatment options.
To further cater to the needs of this patient population, emovis Patient Contact Service and Study Site staff received special training to manage interested participants and patients. emovis was able to grant 419 participants a consultation appointment, of which 44 could be screened and 29 randomized patients were enrolled in the study so far.
PORTICO study is currently in its final phases and emovis is excited about the potential treatment success Vafidemstat could offer.
About emovis:
Founded in 2001 in Berlin, emovis specializes in clinical trials. In addition to the well-known study site in Berlin, the portfolio includes numerous other services related to clinical studies.
emovis has a Quality Management System second to none. In the last 5 years emovis has successfully passed 30+ audits and 3 inspections were performed at our study site between 2013 and 2022 by FDA and LaGeSo.
For more information about our Dedicated Study Site, visit us on: www.emovis.de/en/services/dedicated-study-site/
To speak to a representative, please contact us on feasibility@emovis.de
emovis GmbH
Wilmersdorfer Straße 79
10629 Berlin
Tel.: +49 - (0)30 439 741 610
info@emovis.de
www.emovis.de
Decentralized Clinical Trial services all under one roof: emovis has developed and successfully applied DCT services for clinical trial clients.
Patients are increasingly facing constraints that prevent them from participating in clinical trials. Whether its severe illness or time constraints, participating in a clinical trial is just not always possible for patients. Enabling and promoting patient participation is key for any successful study and this is where DCTs could help.
The company emovis has been known for many years as a Dedicated Study Site service provider in the field of clinical trials and has developed a suite of successful services for conducting Decentralized Clinical Trials. These services encompass a multitude of decentralized elements, such as the Homecare Visits service, that can aid in the conduct of clinical trials. emovis has been offering hybrid DCT services for over a decade now and more services are being made available by the DCT Task Force.
The DCT services offered by emovis include Virtual Study Site, Network Investigators, Digital Patient Recruitment, Brick & Mortar Sites, Supply and Device Management, Local Healthcare Providers as well as Homecare Visits. DCT solutions function as a customizable toolbox for clinical trials. They are tailored made for each individual trial and may be implemented as hybrid or full decentralized.
In order to guarantee the highest level of service possible, the emovis DCT Task Force complies to the regulations outlined by the European Medicines Agency as well as national agencies and will carefully evaluate the study’s needs to assess which DCT elements may be applied. With this successful approach, the emovis DCT Task Force can support the decentralization of clinical trials in the most efficient and safest manner possible.
About emovis:
Founded in 2001 in Berlin, emovis specializes in clinical trials. In addition to the well-known study site in Berlin, the portfolio includes numerous other services related to clinical studies.
As an experienced service provider in the field of clinical trials, emovis has been awarded several prestigious prizes, such as the Clinical Research Site Award and the Innovation DEN Award. emovis is active in over 16 European countries and DCT services are available internationally.
Since its foundation, more than 9,000 patients have participated in studies conducted by emovis. More information about the DCT Task Force can be found here: https://www.emovis.de/en/services/decentralized-clinical-trials/ and contact may be made here: feasibility@emovis.de
emovis GmbH
Wilmersdorfer Straße 79
10629 Berlin
Tel.: +49 - (0)30 439 741 610
info@emovis.de
www.emovis.de
On February 6, 2023, a severe earthquake occurred, which caused great damage in the Turkish-Syrian border region. According to current estimates, thousands of people on both sides died and more than tens of thousands of victims were injured, some of them seriously.
Helpers on the ground urgently need support to assist the many victims. We at emovis also made our contribution and supported the organization "Médecins Sans Frontières". Through emovis and its employees, a total of 430 € could be donated.
The website's new features make it easier for Homecare providers to get started with us and expand the Homecare Visits (HCV) network via targeted recruitment.
For over 10 years, emovis has been known as the leading Homecare Visits provider for clinical trials through its Homecare Visits service. Emovis is now represented in 16 European countries and are continuously working to expand their prime market position. In order to support study sites, CROs and sponsors, the aim now is to make it easier for interested Homecare providers to get started and to expand their own networks. For this reason, the new website was created.
The new website’s major new feature, is the provision of detailed information about the entire Homecare Visits service. This gives prospective homecare providers the opportunity to obtain detailed information about this occupational field and all associated activities in advance. This form of transparent presentation reduces potential uncertainties on the part of applicants and enables a realistic assessment of the requirements and expectations of the future job. It also helps interested candidates to apply for a job as a Homecare provider in a well-founded and informed manner.
Prior to the introduction of new content to the website, suitable Homecare provider were recruited exclusively via various external application portals and networks. From now on however, future job advertisements will also be published on the new website. At the same time, an online questionnaire was designed, which allows applicants to present their details and qualifications for the position in a structured, simple format. Additionally, the use of targeted questions in the online questionnaire offers emovis the opportunity to obtain relevant information about potential applicants in advance. Factors such as willingness to travel and professional experience can be assessed in order to make an informed decision with regard to hiring suitable candidates. The use of such a tool enables emovis to optimize the selection process and identify qualified applicants in a targeted manner.
More content and features are set to be added to the website in the future. Currently, the content is available in German and English. Due to the Europe-wide presence, plans for multilingual content to address and reach potential applicants based in other geographical areas, are in place.
The Homecare Visits section is growing steadily and now has 1.100 Homecare providers in its database.
The new website and all information about the service can be found here: www.emovis-homecarevisits.com/ueber-uns/emovis
A press release by the VFA (German Association of Research-Based Pharmaceutical Companies) stated that Germany is falling behind as a location for clinical drug studies. A realignment is necessary to fight its way from 6th place to 2nd place, which the country previously held in 2016. This will require changes in various places, such as more expeditious contract negotiations.
In a joint press release issued at the beginning of this week, Germany’s leading associations and institutions of clinical research commented on the functional problems of the EU portal CTIS and the resulting consequences for clinical research in Europe.
Clinical research study participants and employees make an important contribution to the development of new treatment methods.
A functioning submission and approval portal is a prerequisite for maintaining the attractiveness of Europe as a location for clinical trials.
As a BVMA member, emovis supports the joint statement of:
Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK).
Federal Association of Pharmaceutical Manufacturers e.V. (BAH)
Federal Association of Medical Contract Research Organizations (BVMA)
Federal Association of the Pharmaceutical Industry (BPI)
German University Medicine e.V.
KKS Network e.V. Network of Coordination Centers for Clinical Studies
Association of Research-Based Pharmaceutical Companies (vfa)
Marketing and patient search from a single source: emovis has developed and successfully applied an all-round service for clinical trial clients.
Berlin - Anyone planning a clinical trial faces numerous challenges, as the search for the ideal study participants often proves to be an enormously time and cost-intensive factor. Suitable and motivated patients must be found in a timely manner and to achieve this, the appropriate activities must be initiated.
Emovis is known as a service provider in the field of clinical studies and has developed a successful service for efficient patient recruitment, including marketing measures and telephone consultation, in the entire DACH region from its 20 plus years of experience - the Patient Access Group.
The recruitment measures start at the planning stage. That’s because emovis already involves its study physicians here and asks them for their feedback. An individual recruitment and advertising strategy is developed for each study, tailored to the respective indication and target group. Multi-channel marketing approaches are used to ensure that the patient population is targeted across print, online, social media and audio channels. Through an extensive database of potential study participants, emovis regularly informs potential participants about current study projects by sending out newsletters. This is just another promising way emovis finds motivated participants.
In order to guarantee trust and commitment on initial contact, a telephone service is offered. This allows interested parties to find out more about the planned study through a conversation with us. Short communication channels to the study center’s team also enable comprehensive feedback as well as insights from the everyday life on the sites. Prompt communication and a high level of transparency in the implementation are further advantages for the recruitment process. With this successful approach, the emovis Patient Access Group can support other sites in German-speaking countries.
We are very pleased that our proposal was accepted and our CEO, Dr. Bettina Bergtholdt, was nominated for this year's Christine Pierre Clinical Trials Lifetime Achievement Award.
Why did we nominate her?
The award honors outstanding achievements by individuals in the field of clinical trials. Very fitting for our executive director! In 2001 Dr. Bettina Bergtholdt founded emovis with a vision: to create long-term solutions for clinical research that makes patients the focus. This is also in line with her motto: "we want everyone to feel like a private patient".
But Dr. Bettina Bergtholdt, doesn’t only score points with her patient-centric approach:
1. As a true entrepreneur, she comes up with innovative ideas to make clinical studies as successful as possible. Over the years, the company has developed from a small study site in Berlin into an international and competent service provider for clinical studies.
2. She supports our clients with her many years of experience, her innovative spirit, and her heartfelt honesty.
3. She inspires employees with her leadership style and corporate culture. As a founder during the turn of the millennium, she was a true pioneer of the modern working world, promoting flexible working hours and work locations. Individuality, personal responsibility, and professional self-realization are the basic building blocks on which our corporate culture is built.
These are all clear reasons for an award! Do you want to support us and give Dr. Bettina Bergtholdt your vote?
Cast your vote until the 10.10.2022 here: get.knect365.com/clinical-trials-europe/lifetime-achievement-award/vote-2022/
The 8th winner the of Clinical Trials Europe will be announced on 07.11.2022 in Amsterdam.
It was exactly 10 years ago that our Homecare Visits service was founded - and has been steadily gaining momentum since – this is an event worth celebrating! Homecare visits are a big topic, especially with regard to decentralized clinical studies - and not just since Corona. Our home visits are visits within the framework of clinical studies that, for various reasons, take place at the participants' homes instead of at the study site or in the clinic. The demand for home visits is high. We have been able to expand our service throughout Europe and are now represented in 16 countries. Our headquarters are in Berlin, Germany, from where our multicultural team manages our staff who are spread throughout Europe.
Read the staff interview with Annika Schuett (Director of Homecare Visits) and Carolina Martins (Homecare Trial Project Manager) Part 1 and Part 2 to learn more about the department's development, successes and goals.
Want to learn more about Homecare Visits? Read more here.
Before a new drug or medical device can be used to treat patients, its efficacy and safety are thoroughly tested in clinical trials.
The Förderverein zum Internationalen Tag der klinischen Forschung e.V. (represented by: Bayer AG, Charité Research Organization, dinox GmbH, emovis GmbH, kfgn - Site Operations & Services GmbH) and the Berlin State Office for Health and Social Affairs (LAGeSo) and the Paul-Ehrlich-Institut has invited to a free information event on May 17, 2022 at the Langenbeck-Virchow Haus in Berlin.
Visitors were able to learn in short presentations, for example, how the side effect is included in the package insert, what role the ethics committee plays, or where to find information on clinical trials.
Next year, this event will also take place in Berlin. We will keep you up to date! You can find more information at: https://klinische-forschung.org/.
We at emovis are very concerned about the current situation in Ukraine. The situation is highly explosive and gives us no peace, because many people are affected - including friends and relatives of our employees. Now we are supporting the Ukrainian population by sending medical care packages via "HWV Ärztebedarf".
Cohesion is especially important in this case, because only together we can make a contribution to help the people in and from Ukraine!
Translated with www.DeepL.com/Translator (free version)
The pandemic continues to keep us on our toes - infection rates are once again rising sharply. To counteract the pandemic, a new drug against Corona is currently being tested. In an interview on Radio Paradiso 98.2's program "Natürlich Gesund", Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures AG, and Renée Werner of emovis talk about the mode of action and possible applications of the new drug, as well as about the current course of the study in the company's own COVID Trial Unit at emovis - for which they are currently looking for participants who have tested positive.
You can listen to the german-speaking interview here: Radio Paradiso.
Last year the IKK BB Berlin company run had to be cancelled due to corona. This year, fortunately, it was able to take place - albeit, of course under the appropriate conditions.
On the evening of September 15th, the time had come: a 5.5-kilometer course was waiting to be mastered. Along with many other companies, emovis had once again sent a few employees into the race. They dressed up accordingly, of course, wearing our team name Staffelokokken on their chest!
The starting point was the Brandenburg Gate. From there, the race went in a circle along Ebertstraße, Tiergartenstraße, and Großer Stern then back to Straße des 17. Juni. The rainy weather did not dampen the mood – as you can see and hear in this video where you’ll see Mariella Brzoska.
Many thanks to all emovis runners for their participation - especially Daniel Schulz, who organized the whole thing so well!
Seven companies, one mission: to advance the education of clinical research: As of July 12, 2021, we and other companies (including BAYER AG and CHARITÉ RESEARCH ORGANISATION GmbH) "Förderverein zum Internationalen Tag der klinischen Forschung e.V." are a registered association. Read more in the following press release!
What is the best way to counter a pandemic? With combined forces! That is why we are pleased to announce that from now on emovis and CRS Clinical Research Services Mannheim GmbH will be jointly dedicated to COVID-19-specific projects:
In March 2021, emovis will be 20 years old, and rightly so: Various goals that we have achieved in the last two decades speak for themselves. By founding the company in March 2001, Dr. med. Bettina Bergtholdt set the ball rolling for all our successes.
In recent years, we have conducted more than 250 clinical studies, and in the process, gained experience with more than 120 different indications. In total, we have recruited more than 7,000 study participants and satisfied more than 100 clients to date.
We at emovis know no standstill: Since our foundation, we have grown steadily, so that we now have a wide range of services at our disposal. Join us in reviewing our biggest milestones so far:
In 2008, we established our sleep laboratory, a high-quality, medically equipped, as well as cozy examination place, where we monitor our patients' sleep. This was followed in 2012 by the establishment of our Homecare Visits service, which enables certain impaired patients to participate in clinical trials. With this new service we were able to successfully complete over 100 projects. In a cancer study, for example, we made 1,500 homecare visits within 20 months. In 2014, our CEO, Dr. med. Bergtholdt, founded the service camovis together with Ms. Kurth: The Flying Study Nurses support study centers that need highly qualified staff during peak periods. In 2018, we added our Early Phase Unit, with a focus on psychiatric indications. Two years later, in 2020, we founded our Patient Access Group, which allows us to recruit study participants quickly and efficiently throughout the DACH region. And now, in 2021, our latest achievement: the COVID Trial Unit – an innovative service that enables us to conduct safe clinical trials with covid-19 patients.
Among all the many clinical studies we have conducted so far, some proved to be particularly successful: In 2008, we were able to recruit 844 study participants within 8 months for a vaccination study against herpes zoster. In 2010, we enrolled 371 participants in 24 months for a smoking cessation study. In 2017, we succeeded in recruiting 239 patients within 15 months for a study on insomnia. In 2019, we were able to enroll 45 study participants for a study on genital herpes within 8 months, reaching 180 percent of our target. In 2020, we conducted a vaccination study on tetanus, diphtheria and pertussis: In phase II of the study, we were able to recruit 153 study participants within 4 weeks and achieved 153 percent of our target. In phase III, we enrolled 345 patients within 3 weeks and achieved 138 percent of our target.
Our successes, however, are not only evident in our study-related numbers but also in external assessments: In 2013, emovis was subjected to an FDA inspection. The result: absolutely no objections. In 2015, we received the DEN INNOVATION AWARD for our Homecare Visits service. In 2016, we received the Clinical Research Site Award. Of course, we are delighted to receive such awards – they drive us forward even more. However, grateful study participants whom we have been able to help in clinical trials have always been and will continue to be the main motivation for our work.
Our stone continues to roll – we look forward to the next 20 years of emovis!
Over 100 years ago a vaccine was developed as a protection against the respiratory disease tuberculosis. It is now being tested whether this vaccine can also help with Covid-19. An infection with the corona virus can have serious consequences for high-risk patients. With this vaccine the course of the disease can be alleviated. The advantage of this vaccine: The vaccine does not target the virus directly but rather the strengthening of the immune system. Therefore, the vaccine does not lose its effects even if the viral strain changes. First results of this study can be expected by summer 2021. We are proud to be involved in this fascinating project.
One thing becomes particularly clear in the times of COVID-19: how important clinical trials are.
Research institutes all over the world are conducting research on a vaccine to protect the population from the new virus. But regardless of the current situation, companies in the field of clinical research make an important contribution every day developing therapy options and the medications of the future.
In this press release from April 2020, BVMA comments on the relevance of the services of BVMA members and calls for the classification as being system relevant.
Patients participating simultaneously at different studies currently became a frequent problem in clinical trials. Mistakes and falsely results are the consequence. Therefore, many leading Research Centres in Germany joined the global database for Verified Clinical Trials (VCT). The objective is to prevent protocol violations, patients double participating and to ensure the data quality.
It is now easier to identify and prevent patients participating at different study sites at once. Without the usage of a tool such as VCT is the recognition of over registration in clinical trials nearly impossible. There are several research locations in the immediate vicinity. Therefore, becoming problematic when study participants visit several study sites at once. Verified Clinical Trials is used to prevent over registration to ensure the safety during the whole study period.
Our Executive Manager Dr. Bettina Bergtholdt: “The safety of our patients is the primary goal in all clinical trials. It is our aim, to offer innovative treatment possibilities and at the same time to ensure their safety. Joining the database of Verified Clinical Trials will definitely aid us to archive this goal.”
The benefits of in-home nursing in clinical trials are numerous and they differ between stakeholder sponsors, CROs, sites and patients. But at what point do you decide to include homecare in your project?
Direct-to-Patient projects are complex and require collaboration and planning. Deliveries must often be precisely timed to coincide with the patient's availability of nurse home visits. Immediate proof that temperature control has been maintained is required prior to administering medication. Patient samples are packages for delivery to testing labs.
All of this requires the highest level of training and professionalism, discover insights on home care visits in clinical trials as we take you through the journey from destination to enrolment.
Key Learning Points:
Agenda:
The event is free of charge, lunch and coffee will be served at the event. Ute Bertelsmann and Rebeca Gonzalez Vicedo of emovis GmbH and emovis Homecare Visits will be speakers at the seminar.
The benefits of in-home nursing in clinical trials are numerous and they differ between stakeholder sponsors, CROs, sites and patients. But at what point do you decide to include homecare in your project?
Direct-to-Patient projects are complex and require collaboration and planning. Deliveries must often be precisely timed to coincide with the patient's availability of nurse home visits. Immediate proof that temperature control has been maintained is required prior to administering medication. Patient samples are packages for delivery to testing labs.
All of this requires the highest level of training and professionalism, discover insights on home care visits in clinical trials as we take you through the journey from destination to enrolment.
Key Learning Points:
Agenda:
The event is free of charge, lunch and coffee will be served at the event. Ute Bertelsmann and Rebeca Gonzalez Vicedo of emovis GmbH and emovis Homecare Visits will be speakers at the seminar.
Sign up here
This year’s PCT Europe is held in Amsterdam from Nov. 28 – 29. emovis will be in attendance and Dr. Bettina Bergtholdt can be experienced within the framework of the congress multiple times with her expertise. 1st as a panelist on the panel "Recruitment from the perspective of an investigative Site – pitfalls and strategies" as well as in a workshop on Nov 27, addressing the topic "Briefing Day A: The Outsourcing and Partnering Forum".
emovis will not only attend the professional congress"Next Generation Nicotine Delivery Conference 2017" on Nov. 14 -15, you may encounter the Managing Director emovis-,Dr. Bettina Bergtholdt as a panelist. Together with Dr. Alexander (Sascha) Nussbaum from Philip Morris she will share her expertise in the subject "The role of clinical trials in driving the success of new nicotine products".
München, 23 November 2017. Prior to its 25th Symposium, the Federal Association of Contract Research Organisations (BVMA e.V.) in Germany announced the election of the new Executive Board. Martin Krauss was elected to serve as President. Martin Krauss is co-founder and Managing Director of FGK Clinical Research GmbH and has been a member of the Board before. Ralf Freese from CTC North GmbH & Co. KG was appointed Vice President. Also joining the Board is Dr Yvonne Rollinger, Managing Director of OmniComm Europe GmbH.
Dr Dagmar Chase, Managing Director of Clinrex GmbH, a Board member since 1993 and President since 2001, as well as Dr Michael Gierend, Managing Director of medicomp GmbH, Board member since 1997 and Vice President for 16 years, were no longer standing for re-election.
Dr Dagmar Chase about the new appointments: “The BVMA is an important stakeholder of clinical research in Germany. It was very important for us, the previous Board members, to have a smooth transition to the new executive leadership, and this can now be accomplished. A new generation will now take over leadership, but will still be supported by previous Board members who continue their membership in the association. The new Board with Martin Krauss as President is well-positioned and well-prepared to continue the Association’s successful work.”
“The new Board is looking forward to take on its duties and new challenges”, the new President Martin Krauss commented on his appointment. “Clinical research faces constant changes - digitalization is just one example - and new developments come up more and more frequently. A close cooperation and exchange of information between members, representatives from industry, regulatory bodies, ethics committees, and other stakeholders are essential to keep up with these growing demands. The BMVA will also focus in the future on keeping Germany attractive for clinical research and strengthening clinical research for the patient’s benefit. I would like to express gratitude to Dagmar Chase, who has been the BVMA’s president for many years, and has made the BVMA an important stakeholder.”
About BVMA:
The BVMA was founded in July 1991 as a representative body for CROs (Contract Research Organisations) based in German-speaking countries. The current 41 members are service providers in research and development of pharmaceuticals and medical devices. Throughout Germany, the BVMA represents about 4000 employees in clinical research. In the past years, the association has successfully strived to be represented in relevant regulatory bodies. As a co-founder and member of the European umbrella organisation (European CRO Federation, EUCROF), the BVMA also ensures its international position. The current President of the EUCROF, Dr Martine Dehlinger-Kremer, is a BVMA member. The BVMA is based in München, Germany.
BVMA symposium:
Every year in November, the BVMA organises a symposium, which became (with more than 300 participants) one of the most important conferences in clinical research. At the same time, the symposium has served for the last 25 years as an established platform for the exchange of information between stakeholders in this field.