emovis by FutureMeds is the site networks’ first dedicated research site in Germany. The emovis team is experienced, well-equipped, and determined to consistently deliver: reliability, efficiency, and quality. In clinical research, these words have a serious impact on patient experience and a multi-million-dollar meaning for Sponsors and CROs.
The Berlin-based emovis has been a reliable, versatile service provider for phase Ib-IV clinical trials since its establishment in 2001. Their experienced team recruited more than 9,000 patients, reaching promised recruitment numbers in 90% of over 250 trials in 120 indications across 14 therapeutic areas. emovis also successfully passed more than 30 audits in the last 5 years.
The emovis dedicated research site team will continue their success story under the FutureMeds umbrella and remain on mission to contribute to medical progress while keeping the well-being of the study participants a top priority.
History and Experience
emovis was set up by Dr Bettina Bergtholdt, a nationally and internationally recognised clinical research professional. Although, at the outset, the site was small, consisting of only a few rooms, the core ethos, the values and the focus of the team put the company on a strong growth trajectory. emovis, now spreading across 4 floors, worked with over 100 clients in over 250 trials.
Led by Ninon Armbrust, Site Director, a former qualified nurse with operating theatre experience and ongoing business administration education, the emovis team can deliver highly complex protocols and efficiently recruit high numbers of patients in a short period of time.
The site's primary focus has been CNS and mental health; they have already conducted over 50 depression studies. Besides CNS, Emovis has a proven track record of delivering studies in the following therapeutic areas: Allergy / Immunology, Cardiovascular Diseases, Endocrinology and Metabolism, Gastroenterology, Infectious Diseases, Rheumatology, Orthopedics, Pain, Urology, Dermatology, Pulmonology, and Vaccination.
Facilities and Infrastructure
The site, which is well-known and trusted by patients, is not a run-of-the-mill research site. The interior design and decoration aim to create a sense of safety and calmness. This is especially true for the combined Sleep Labs and Early Phase Unit.
On the ground floor, the team usually conducts high-recruiting projects. The 1st floor is the administrative heart of the operation. It houses the study coordinator, project manager, site director offices, and also the monitoring room for the CRAs.
The 2nd floor is home to emovis' outpatient study site. This floor is dedicated to phase 2-4 studies and has six doctor rooms and three laboratory rooms.
Sheltered from distractions, the Early Phase Unit and the Sleep Lab, with 3 inpatient rooms, are situated on the 4th floor.
Sleep Lab
The state-of-the-art, fully equipped rooms with video-monitoring and polysomnographic measuring stations can be used to monitor three patients or participants at the same time. The diagnostic procedures include:
Electroencephalography (EEG)
Nasal respiratory airflow (NAF)
Thoracic respiratory motion (THO)
Abdominal respiratory motion (ABD)
Electrocardiogram (EKG)
Blood pressure (RR)
Arterial oxygen saturation test via finger sensor (pulse oximetry)
Body temperature
Electromyogram (EMG) – Recording muscle movement in the legs and masticatory muscle
Electrooculography (EOG) – recording eye movement
Sound recording
Video recording
Offering both study site capabilities and a sleep lab guarantees efficiency: most examinations can be performed at the site without the need for the patients to leave.
Early Phase Unit
The Early Phase Unit is dedicated to Phase Ib studies. These are usually conducted with healthy participants to test new treatment methods. To shorten the path from the first-time human trial to proof of concept as much as possible, emovis offers the valuable combination of competence and dedication, as well as the ability to recruit a large number of patients with quality, care, and speed.
Clinical Team and Expertise
Under the leadership of Ninon Armbrust, 6 Investigators (2 Physicians, 2 General Medicine Specialists, 2 Specialists in Neurology), 8 Research Nurses, 2 Psychologists, 3 Project Managers, 2 Receptionists, and 1 Assistant are responsible for delivering the best trial outcomes for patients and clients.
emovis’ internal investigators are highly qualified and have a strong track record of establishing and maintaining high patient retention and engagement throughout the course of trials. The site also cooperates with external licensed doctors to cover medical specialisations to meet study-specific needs. These include but are not limited to General Medicine, Dermatology, Gynecology, Otorhinolaryngology, Gastroenterology, and Psychiatry.
emovis’ 4 Administrative Study Nurses and 4 Lab Study Nurses have biology, biotechnology, chemistry, and medical backgrounds. They focus on the successful initiation, planning, execution, and smooth delivery of studies, as well as trial close-out visits.
“When I became director, my biggest goal was to foster a great team spirit. The team has grown a lot, and we've become very close. It's really important to me that people can develop freely in my department and that everyone can use their strengths perfectly. I want every employee to enjoy coming to work.”
- Ninon Armbrust, Site Director at emovis by FutureMeds
Population Profile, Patient Pool
emovis’ database has over 28,000 active contacts in the patient database. Approximately 33% (9,200) of contacts live within a 6-mile radius of the clinic. Moreover, about 62.5% of the contacts (17,500) have subscribed to the newsletter to receive regular updates about trials.
By building their reputation and strong brand awareness and using effective localised patient recruitment methods, the team can reach patients who are likely to meet the requirements of a given protocol in a short period of time.
“We have the advantage of having a city of millions with high diversity. This gives us access to all patient groups. Another benefit is that our site in Berlin's heart is centrally accessible.”
- Ninon Armbrust, Site Director at emovis by FutureMeds
Quality and Compliance
The highly qualified team lives for quality. And this is not just a motivational statement within the team. Their professional approach is underscored by over 250 successful trial deliveries, 3 successful inspections, and 30+ successful audits. In 2013, Emovis passed an FDA inspection with no major or critical findings.
Moreover, in 2016, the dedicated study site received the Clinical Research Site Award from INC Research.
It goes without saying that trials at emovis are conducted strictly in accordance with IATA and ICH/GCP guidelines.
As Quality Assurance is a top priority for emovis, the site readily invests in regular training and process revision to improve operational efficiency and quality. Ninon Armbrust receives weekly updates on the quality of the individual projects from my project managers, reviews existing SOPs annually, and holds non-negotiable brief but impactful retrospective sessions at the end of each departmental meeting to reinforce the latest SOPs and keep everyone up-to-date.
“Usually, it is very hard in the daily operation of any business to review how the procedures within SOPs perform and keep everyone up to date regarding the improvements. So we dedicate the last 10 or 15 minutes of every department meeting for retrospective sessions to discuss what we can improve.”
- Ninon Armbrust, Site Director at emovis by FutureMeds
In addition to the thorough training, regular internal audits and random quality control checks are performed at the site. Audits initiated by the BVMA and sponsors are also carried out regularly to ensure that all emovis processes and procedures are up to code.
Thanks to the QA sessions, trainings, audits, and SOPs, emovis can
Guarantee patient safety at all times.
Ensure accurate and timely data collection and data documentation.
Recruit within the forecasted time window and budget.
Provide solutions to occasional sponsor and CRO logistical challenges.
Communicated proactively predictable "issues" in the area of protocols and eCRFs.
Recent Success Stories
Borderline personality disorder study:
The study commenced patient enrolment in mid-2022 and saw a remarkable interest.
Over 1,000 people reached out within the first six months.
The success can be attributed to both emovis' highly efficient recruitment tactics, the team's commitment and dedication to advancing BPD treatments, and the demand for new BPD treatment options.
TDAP vaccine trial phase 1:
emovis was commissioned to conduct a vaccination study on tetanus, diphtheria, and pertussis, for which a blinded and an unblinded team had to be assembled.
These two teams recruited 152 patients in less than 2 weeks.
To cope with high-recruitment numbers, emovis kept open the study site even on weekends.
TDAP vaccine trial phase 2 (6 months after phase 1):
emovis only had 2-3 weeks for recruitment, and forecasts suggested 150 patients could be recruited within that time window.
However, the site director knew more could be done, so with a colleague, they looked at how to utilise the staff and rooms best.
As a result, the team managed to randomise 351 patients within 2 ½ weeks without any quality issues.
Influenza study:
Patient recruitment was capped at 70 for each site participating in the trial.
emovis hit the recruitment cap within 2 weeks.
Due to performance issues of other European sites, the Sponsor granted the remaining recruitment rights to emovis.
Although emovis' trial pipeline was full by that time, the team found a way to enrol another 30 patients within a week.
Insomnia Study:
The emovis team enrolled 239 patients in the study within one year using 3 beds only.
The operational aspect of the trial is a testament to the team's organisational, project management skills and the streamlined SOPs.
Due to their performance, emovis became the top-performing German site and was ranked among the top 10 globally.
Patients were satisfied, and the following audit had no major or critical findings.
Covid Trial Unit:
Despite initial disruption due to COVID-19, emovis identified a new opportunity in clinical research and initiated a COVID Trial Unit in the summer of 2020.
The process of setting up the COVID Trial Unit was complex, ensuring compliance with various guidelines and working closely with governmental bodies.
emovis successfully launched the COVID Trial Unit at the beginning of 2021, initiating work on the first projects that included over 1000 interested people contacting the site.
Conclusion
emovis is a Dedicated Research Site with
An established patient database,
Strong regional experience,
High levels of patient recruitment capability, and
A reputation for producing high-quality data. The latter is underscored by over 30 Sponsor audits and 1 FDA inspection.
Similarly to other FutureMeds sites, emovis provides fully integrated services throughout a growing range of therapeutic areas to support the development of drugs and treatments that transform healthcare. emovis also offers a fully equipped Sleep lab, Early Phase Trial unit. On top of this, due to their experience in conducting hybrid trials and DCT and homecare expertise, the team can greatly accelerate study delivery.
About FutureMeds
FutureMeds is the 1st European DCT Site Network, offering high traditional and DCT readiness across the whole network and home nursing solutions in 16 countries.
FutureMeds’ Dedicated Research Site teams strive to accelerate study timelines, streamline processes, lower costs and improve data quality to help speed up drug development and patient access to new treatments.
Through acquisitions and a strategic focus on patient experience, FutureMeds has developed large, qualified patient pools across Europe that enable faster patient enrolment, stronger retention and more accurate results.
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