Comprehensive quality management has always been a part of Invisio Clinical Studies Consulting’s DNA. In August 2021, the Mannheim-based clinical research organization went one step further and became certified according to the DIN ISO 9001:2015 Quality Management Standard. The initiative to achieve this accomplishment came from Managing Director Florian Schnabel. In explaining his motivation to become certified, he said: “One goal was to further professionalize internal and external processes. We were also looking for a way to demonstrate to our business partners that we meet internationally comparable quality standards. With this certification, potential clients now immediately know whether our way of working and operating meets their requirements. This reduces their workload and saves them time.” Dr. Christina Gehbauer, Clinical Project Manager, internally supervised the process, and Alina Varaksin, Management Assistant, supported her throughout the entire process. Moreover, Invisio brought in an external consultant in order to be as well prepared as possible for the audit. The external consultant examined existing processes and documents, identified potential for improvement, and prepared the team for the Dekra’s official audit by submitting the team to a trial audit.
Invisio is implementing a comprehensive set of measures
In regard to the certification process, Christina Gehbauer said: “We were able to build upon our existing quality management system. It was very helpful that we were already working with controlled documents and a predefined folder structure, and that we documented all the duties and responsibilities for the trials in a comprehensible way.” Gehbauer explained that the ISO certification has revealed potential to Invisio that it now wants to exploit by taking various measures. These included, among others, writing an Invisio quality management manual, creating clearer and more precise project-specific documents, and establishing centralized evaluation systems. “In order to be in the position to evaluate customer feedback in an even more targeted manner after completing a project, we are now documenting feedback from our customers via a standardized online questionnaire,” the project manager explained. In addition to the aforementioned improvements, an annual management review has also been implemented. “In combination with evaluations and risk analyses, this regular review makes it clear what went well and where we must take action. By doing so, we can continuously improve, further develop our offering, and be able to respond to potential challenges in time,” emphasized Florian Schnabel. Another plus point for him is that the management review reveals strategic perspectives and enables business decisions to be based on transparent processes and to be made in a reflective manner.
Schnabel and Gehbauer agree: Good quality management systems help them meet their responsibility to their customers and keep their promises. They explained that “for this reason, we would also like to become recertified when the time comes. In 2022 and 2023, there will be surveillance audits for which we will have to prove that we have achieved our goals and are constantly developing and improving. In 2024, the reaudit will follow.”
When the Bionnale 2021 opens its virtual doors on May 12, Invisio Clinical Studies Consulting and its digital booth will be there as well. “We look forward to inspirational lectures and having fruitful discussions with interesting companies”, says Florian Schnabel, Managing Director of the Mannheim-based study service provider, about their participation. He thinks that the new format is a good alternative for him and his team to make new contacts and deepen existing ones, despite the corona pandemic. As Invisio has continued to expand its international activities in recent years, Florian Schnabel would like to expand his professional network in other EU countries as well. “We are specifically looking for partners for European projects so that we can grow even faster outside of Germany and benefit from synergistic effects,” he explains. His target group includes sponsors and representatives from the pharmaceutical, medical technology and biotechnology industries within the European Union.
Florian Schnabel has assumed a dual role at the Bionnale. Together with his team, at the event he will present Invisio, as well as the companies ClinCoach, ClinGenius and ClinMatch from Münster in North Rhine-Westphalia. He is part of the management team of these start-ups that were founded in 2020, which see themselves as platform companies. They operate in partnership with Invisio and are working together for a digital study world.
It is precisely knowledge deficits in the important basic research area of good clinical practice that have a direct negative impact on the entire course of studies.
GCP courses and certificates are constant companions to our work, whether through our own Flying Study Nurses or other business contacts. That is why we have become acquainted with numerous providers and approaches over the past few years – but none of them has completely convinced us. With ClinCoach, we have finally been able to implement our ideas of an innovative and effective GCP course that offers clients and study personnel many advantages,” says Invisio CEO Florian Schnabel.
ClinCoach, the innovative e-learning platform for clinical studies, and the Mannheim-based study provider were also able to inspire industry expert and GCP expert Dr. Wolfgang Eglmeier for this exciting project. In this way, a completely online Good Clinical Practice course was developed in close cooperation, which has already been certified by TransCelerate BioPharma and is currently submitted to the German Medical Association for approval of continuing education credits.
“After an extensive search, we found a serious partner who, despite the current shortage of PPE material, was able to supply us with a large number of FFP2 and surgical masks,” explains Florian Schnabel, managing director of the Mannheim based study service provider. “We had the quality of the mask material additionally tested by the Institute for Occupational Safety and Health of the German Social Accident Insurance; its quality was confirmed. Even during this sensitive time, the protective masks enable us to maintain internal safety standards and provide our Invisio Flying Study Nurses, patients, and business partners with high-quality equipment.” In order to equally relieve both the study participants and the medical staff in the trial centers, Invisio is reorganizing patient care. Schnabel: “As far as possible, our goal is to care for patients at home and to offer them the best possible care while there. This reduces their travel considerations, and they are less exposed to the risk of infection.” The adjustment has already been completed in many projects. Nevertheless, clinic-based care is also continuing. “This applies in particular to trial centers to which we still have unlimited access. Here, we adapt our approach to the individual conditions on site,” says the managing director.
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“For the past year and a half, we have noticed that the demand for flying study nurses as well as for expert help in the implementation of clinical study projects has increased throughout Europe. To be able to meet these customer requirements, we have taken the next step and expanded our network to include international partners. Our goal is to increase the number of phase 1 to 4 clinical studies in the countries within the European Union,” Invisio CEO Florian Schnabel commented. For the coming year, the Mannheim-based study service provider expects to support 60 to 100 study centers across the EU in clinical study projects.
In which countries can Invisio implement clinical study projects?
Invisio is already regularly active in Germany, Austria and Switzerland. In addition to the DACH region, the company can also manage projects in Belgium, the Netherlands, Luxembourg, France, Spain, Portugal, Italy, Croatia, Hungary, the Czech Republic, Slovakia, Poland, Finland, Sweden, Denmark, the United Kingdom and Ireland.
What services does Invisio offer outside Germany?
The focus is on project management and supervision of clinical multi-center studies in phases 1 to 4. In other words, Invisio implements parallel international study projects in different European countries. The Invisio Flying Study Nurses work closely with the trial centers and the Principal Investigator (PI) on site and support them in implementing the study procedures and requirements in accordance with GCP/ICH guidelines, as well as in handling the projects on schedule and with rapid patient recruitment. Furthermore, they are actively involved in optimizing patient recruitment.
How does Invisio ensure the quality of its services abroad?
Invisio has transferred its internal structures and guidelines to all countries in which it is active in order to meet its own quality and safety requirements. This includes, as a matter of principle, only employing trained study assistants who – regardless of their location – are bound by the same internal guidelines and Standard Operating Procedures (SOPs). In addition, Invisio prepares project-specific SOPs and draws up concrete work instructions with the respective sponsors in advance, which prepare the Invisio Flying Study Nurses in the best possible way for the required activities and also include solution proposals for unexpected situations. As a rule, sponsors involve a Clinical Research Organisation (CRO) as a supervisory body, which provides early warning of potential challenges.
In order to make the cooperation in the trial centers and the care of the patients as smooth as possible and to avoid misunderstandings, all Invisio Flying Study Nurses will speak the respective national language fluently or at native language level.
How does Invisio position itself to create the additional workload?
Internally, Invisio is broad enough to cope with the tasks of daily business. For individual tasks, the core team nevertheless works together with external partners. These include project managers who, if required, support the realization of clinical studies in other European countries. In these cases Invisio makes sure that the employees have the appropriate language skills. In addition, Invisio cooperates with several internationally active consulting firms which assist the company in the search for suitable specialists.
Dear Business Partners,
In the truest sense, 2019 was an eventful year for Invisio Clinical Studies Consulting. We have been able to increase our pool of Invisio Flying Study Nurses from 93 study assistants to 127 employees compared to the previous year. This growth has also enabled us to more than double the number of trial centers managed by us and our Invisio Flying Study Nurses from 28 in 2018 to 67 in 2019.
This fall, we expanded Invisio’s range of services to include the systematic recruitment of study participants to thus hone our profile as a solution provider for the implementation of clinical trial projects. The target group of the new service are sponsors and CROs. We support them in ensuring projects run smoothly, and adhere to the time schedule and budget plans for clinical trials. Notwithstanding this change, our core tasks continue to be the placement of Invisio Flying Study Nurses and the project management of multicenter clinical trials.
The withdrawal of Christine Duwe-Kraatz from the Invisio management team in 2019 also heralded a change in personnel. Duwe-Kraatz will continue to support the company as a consulting partner in the future and will also be responsible for individual customer projects. The team at the company’s headquarters in Mannheim was strategically expanded to ensure the transition went smoothly. Together, we moved into our new business premises in the second half of the year and also expanded them.
Strengthened by the positive experiences from 2019, we have already taken the first preparatory steps to make 2020 an equally exciting financial year for Invisio. A major milestone will be the ongoing internationalization of the company. Following on from various projects in the DACH region, we plan to align our capacities such that we can be active in the future from France through Sweden to Hungary and Italy. We look forward to your continued support and would like to take this opportunity to express our thanks for the trust you have placed in us in the past.
But the Advent season does not just offer an opportunity for entrepreneurial retrospectives and outlooks, it also invites you to think of other people. We have done this and decided for the first time not to send Christmas cards but instead to support the aid organization World Vision instead. Invisio has sponsored three children – one girl from Thailand and one from Burundi, and a boy from Zimbabwe. We hope that this annual donation will make a contribution to improving their future prospects in the long term.
I wish you and your families a Merry Christmas, restful holidays and a good start into a successful new year.
With best wishes, Florian Schnabel
After more than 25 years in clinical research and around ten years dual leadership of Invisio, Christine Duwe-Kraatz has retired from the management of the Mannheim-based study service provider. She still supports the company as a consulting partner and in this capacity is responsible for various customers and projects. “We are delighted that Christine DuweKraatz will continue to contribute her knowledge and experience. Her gradual exit from the day-to-day business enables us to design the transition optimally and avoid any bumps along
the way,” explains Invisio managing director Florian Schnabel. It is also positive that a permanent study nurse in Mannheim recently took over some of Duwe-Kraatz’s areas of responsibility – both for new and ongoing projects.
Since September 2019, Alina Varaksin has also joined the team as assistant to the management. She supports Florian Schnabel in day-to-day business and project management and is the contact person for clients and study nurses.
Alina Varaksin studied health management in Mannheim and successfully completed her bachelor’s degree in 2017. Prior to joining Invisio, she worked as a management assistant with a focus on sales support.
„Wir freuen uns auf die Teilnahme am Bundeskongress der Studienassistenten und auf interessante Gespräche mit Fachkollegen“, sagt Florian Schnabel, Geschäftsführer von Invisio Clinical Studies Consulting. Ausgerichtet wird die zweitägige Veranstaltung Anfang November vom Bundesverband der Study Nurses / Studienassistenten in der klinischen Forschung e.V. (BUVEBA), in dessen Vorstand Florian Schnabel Mitglied ist. Darüber hinaus engagiert sich der 34-Jährige bei BUVEBA als zweiter Schriftführer und ist Teil der Arbeitsgruppen Datenschutz DSGVO sowie Fort- Weiterbildung / Ausbildung.
Netzwerken bei buntem Veranstaltungsprogramm
Geht es nach dem Unternehmer, bietet das Branchentreffen eine gute Gelegenheit, bestehende Verbindungen zu intensivieren und gleichzeitig neue Kontakte zu knüpfen. „Mit dem steten Wachstum von Invisio erhöht sich unser Bedarf an ausgebildeten medizinischen Fachkräften. Daher freuen wir uns darauf, in Bayreuth mit neuen Flying Study Nurses ins Gespräch zu kommen“, erklärt Schnabel.
Neben dem Netzwerkcharakter des Branchentreffens schätzt der Geschäftsführer auch das vielfältige Veranstaltungsprogramm. Es werden verschiedene Vorträge zu Themen aus der klinischen Forschung angeboten, ebenso wie ein GCP-Refresher-Kurs. Zudem wird während der Mitgliederversammlung der neue BUVEBA-Vorstand gewählt.
“Invisio Clinical Studies Consulting carries out national and international clinical studies with the support of more than 100 trained study assistants, and we would like to ensure they have the best-possible coverage while performing their tasks,” says Managing Director Florian Schnabel. Invisio went searching, therefore, for a partner who was able to offer them company and professional liability insurance specifically tailored to the work of study assistants, and they found it in a large international insurance company. “Together,” Florian Schnabel explains, “we have created a product that provides study assistants with the most comprehensive basic insurance possible. It covers three cases annually: personal injury, material damage and financial losses. The insured amount adds up to a lump sum of three million euros a year.” If the study assistants take out such a contract, the study services provider assumes responsibility for the ensuing costs. The insurance applies personally to each Invisio Flying Study Nurse. This means that they are also insured if a claim occurs while working on projects for other clients.
Protection of private assets
Why did the Mannheim-based company take this step? “Invisio itself is insured against a wide range of damage and losses,” says Schnabel. “However, our insurance does not cover our Invisio Flying Study Nurses in all cases, as they are often not our permanent employees. This means that they, as well as other self-employed persons, run the risk of being personally liable for any damages that occur during their daily work if they do not have appropriate insurance cover. We would like to counteract this.” When it comes to liability issues, he adds, it is also a big advantage for sponsors and CROs if both Invisio as a company and every Invisio Flying Study Nurse is personally insured.
From the company’s perspective, it is important that study assistants are protected against both property damage and personal injury. It is always possible for minor mishaps to occur during the hustle and bustle of everyday life – with high subsequent costs. Even Invisio Flying Study Nurses are not immune to accidentally spilling coffee on a laptop keyboard while working in the test center or clumsily knocking over a valuable floor vase in the hallway during a patient visit. “Another classic example is the loss of keys or key cards”, says Florian Schnabel. “If the entire locking system of a study center needs to be replaced, the invoice can easily amount to several thousand euros. It can hurt a lot to have to pay these amounts from private assets.”.
Educational work necessary
Designing the contents of the insurance in detail was a time-consuming process – especially as the job description of the Flying Study Nurse is relatively unknown. Florian Schnabel needed to talk to many insurers to find and design the right insurance for his needs, and in some cases quite a lot of educational work was required. “Working together with our current partner, we were able to create a product to meet the needs of this modern profession from our point of view”, says the Managing Director, stating that the company and professional liability insurance was well received.