Invisio visits DACH Symposium 2022

After Berlin and Leipzig, the next stop for Invisio: Salzburg. Invisio’s Chief Executive Officer Florian Schnabel and Clinical Project Manager Dr. Christina Gehbauer will be visiting the DACH Symposium on Clinical Trials in the Austrian city from May 30–31. Invisio is supporting the thee-country congress as a roll-up sponsor.
What is Florian Schnabel looking forward to most? The professional input of the speakers and the personal exchanges. “We’ve had many video conferences over the past two years. That was a good alternative for staying in contact with business partners in a way that complied with Covid-19 restrictions. But now we’re pleased that we can have fruitful discussions in person and on site once again.” The CEO would like to lead these discussions with sponsors and players from the medical technology, biotechnology, and pharmacy sectors, among others. But also with study staffs and clinical research associates. “Not only have we successfully survived the coronavirus pandemic,” says Florian Schnabel, “but we’ve actually grown throughout Europe, and we plan on continuing this growth. The DACH Symposium offers us the chance to find exciting collaborators for interesting projects.”
In Salzburg, Florian Schnabel will also be spreading the word on the start-up ClinCoach, which he cofounded. Its portfolio includes digital training for clinical staff (including GCP online courses), standardized self-teaching offers, and custom-fit online courses for pharmaceutical customers.

Will you be in Salzburg too at the end of May? Then we’ll look forward to hearing from you.
If you would like to learn more about Invisio and its services, please feel free to make an appointment in advance with Florian Schnabel and/or Dr. Christina Gehbauer.

To do so, please write an email to info@invisio.eu
or call the following number +49 (0)621 / 180 685 940

Invisio trade show appearances May 2022

Invisio is kicking off the trade show season with an appearance in Berlin. On May 11, the Mannheim-based clinical study consultancy will have a booth at Bionnale 2022, scheduled to be held in the venues of Urania Berlin. After being physically at the trade show, Invisio is also going to take part in the event virtually. Registered visitors will have the opportunity to navigate through the company’s digital booth and find out more about its services. As in 2019 and 2021, Invisio is continuing its support for Bionnale in 2022 as a Gold Sponsor. On May 12 and 13, the Invisio team will be heading to Leipzig for the 16th Symposium of DVMD (Professional Association for Documentation and Information Management in Healthcare). Similarly, Invisio is a sponsor of this event and is providing the conference bags for visitors.

“It is great that in-person industry events can take place once again after going through two years of the coronavirus pandemic and having mostly virtual meetups. We look forward to seeing many familiar faces in person and having interesting conversations,” says Florian Schnabel. His goal: expanding his own network and finding potential partners for new business activities in EU countries outside Germany. In particular, he has set his sights on sponsors and representatives from the pharmaceutical, medical technology and biotechnology industries as well as study nurses and clinical research associates. “Invisio has grown all across Europe in the past years. And we want to stay on this track. That is why we are looking for companies and professionals to work with us on challenging projects,” explains Florian Schnabel.

During the two events, Florian Schnabel will give information about the services of ClinCoach. The start-up from Münster in North Rhine-Westphalia offers advanced digital training for clinical professionals, such as online GCP courses. Besides standard self-learning programs developed by ClinCoach, the company also provides study-specific online courses for clients from the pharmaceutical industry. Florian Schnabel is part of ClinCoach’s founding team.
Take advantage of this opportunity and book an appointment to talk to us!

Are you going to be at the events in Berlin and/or Leipzig and would like to find out more about Invisio?
You can arrange an appointment in advance with Florian Schnabel, Dr. Christina Gehbauer or Alina Varaksin.
Please send an email to info@invisio.eu
or call us at +49 (0)621 / 180 685 940

Invisio wishes you a Merry Christmas

Dear business partners,
The turn of the year is approaching rapidly and I would like to take this opportunity to thank you for the good and trusting cooperation in recent months. Together, we have succeeded in initiating new clinical studies and advancing ongoing projects. The fact that Invisio Clinical Studies Consulting was able to maintain its daily business at all times even in the second year of the coronavirus pandemic and did not have to resort to short-time work at any time makes me look positively into the future. This was possible because we have remained true to our solution-oriented way of working: On the one hand, we flexibly completed organizational and administrative tasks working in home offices during the lockdown. On the other hand, we had already expanded our homecare offer at the beginning of the coronavirus pandemic and looked after study participants at home. We were able to fall back on these structures and thus reduce the number of visits to study centers, thereby relieving some of the pressure for clinics.

For Invisio, 2021 was all about internal development: With Dr. Christina Gehbauer, we have expanded our team to include a Clinical Project Manager who has taken over the project management of international study projects and EU-wide multicenter studies. As a contact person for the international market, she is also working to strengthen our position abroad. In addition, we have dealt intensively with the topic of quality management and improved our processes. In the summer we passed the audit based on the quality management standard DIN ISO 9001:2015. In order to further expand our network, we have broken new ground and gained experience with virtual trade fairs for the first time as a sponsor and participant of Bionnale 2021.

There are two major topics on our agenda for the coming financial year. On the one hand, we would like to further develop the international market with new projects in the European Union and the DACH region. On the other hand, we plan to expand our portfolio and counter the issue of a shortage of skilled workers with our own training and further education courses.

Finally, I would like to mention that we are still not sending Christmas cards and are instead supporting a social project. As a result of the flood disaster in the Ahr Valley, Katholische KiTa gGmbH Koblenz has launched a fundraising campaign for five damaged daycare facilities and employees affected by the flood, in which we will participate.

Together with the entire Invisio team, I wish you happy holidays and a good start to a healthy and happy New Year. We look forward to supporting you in your study projects in 2022 as well!

Ihr Florian Schnabel

Invisio – Now DIN ISO 9001:2015 Certified

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.”

Invisio team represented at Bionnale 2021

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.

Invisio goes Good Clinical Practice: Learn effectively online for practical application

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.

Part II: Introduction of Invisio Flying Study Nurses before and after a project begins

In the second part of the article series Clinical Studies with Flying Study Nurses, he explains how the services of the Mannheim-based study service provider differ before and after the start of the project.

“Study assistants work flexibly and can therefore enter clinical studies at any time,” says Florian Schnabel, Managing Director of Invisio Clinical Studies Consulting. The core business of the Mannheim-based study service provider includes placing trained Flying Study Nurses in national and international phase 1 to phase 4 clinical studies. Nevertheless, Schnabel recommends planning the use of Flying Study Nurses at an early stage and not only bringing them on board once the implementation process is lagging — or even at a stillstand. “The earlier professional Flying Study Nurses relieve the medical staff and take over the coordination of the study on site, the sooner they can start the project and/or work through open issues,” explains the Managing Director. From his point of view, the cooperation of external study staff offers further advantages such as: compliance with international quality standards; a higher patient recruitment rate; minimization of the risk of unscheduled costs due to delays in the flow of the project; no downtime due to the use of substitute personnel; intensive patient care; the control of the study by a central on-site contact person.

Invisio services before the project starts

Florian Schnabel sums up the services Invisio provides when the company is involved before the project starts as follows: “From our network with German and European trial sites, we suggest the ones with the most promising recruitment rates to our clients. Then, within a few days, we put together a team of Invisio Flying Study Nurses to oversee the sites.” In addition, Invisio plans the assignments and travel of external study personnel in consultation with the trial sites and supports them in implementing the requirements for data protection and confidentiality.
In order to avoid overlapping work and misunderstandings, Invisio defines the responsibilities in the project in advance with its customers. Together with them, it develops project-specific work instructions and workflows/SOPs according to which the Invisio Flying Study Nurses are trained. The training sessions take place either directly at the trial site, at the respective sponsor’s, or at Invisio in Mannheim.
In addition, the study service provider accompanies the onboarding process of the Invisio Flying Study Nurses in the trial sites and, in consultation with the sponsor, prepares patient care at home. “For example, we ensure that even in such cases, our study assistants are equipped with the necessary protective gear such as gowns, disinfectants, and masks. We also provide practical solutions for the transport and storage of medicines as well as the logistics and processing of samples,” says Florian Schnabel.

Invisio services after the project starts

In general, Invisio also places study staff if the projects have already started. “In these cases, we also take over the recruiting and resource planning, familiarize the Invisio Flying Study Nurses with the specifications and procedures at the trial site, and coordinate with them,” explains Florian Schnabel. “At the customer’s request, we can also analyze how economically the participating sites are working with regard to the study project and, if necessary, make recommendations to achieve optimization potential.”

Invisio Corona Update II

“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.

Would you like to have the participants of your study cared for at home?

We are always available to answer your questions. Please feel free to contact us.

Invisio Corona-Update I

Dear business partners,
Even in these challenging times, Invisio Clinical Studies Consulting is by your side as a professional partner. In order to continue to provide you with the best possible support for your clinical trial projects, we have adapted our working methods to the requirements of the corona pandemic wherever necessary and useful.

One of our primary goals is to make it as comfortable as possible for patients to participate in your clinical trial and to minimize additional burdens — such as the risk of infection, travel times, postponements, or delays in the trial process. To ensure that we succeed in this, the Invisio Flying Study Nurses are  increasingly looking after trial participants at home. With this step, we limit visits to trial centers to a minimum while simultaneously relieving their doctors and medical staff.

How do we approach this? In order to protect both the trial participants and our staff with all available means, we have decided on new measures. This also includes that our Invisio Flying Study Nurses clarify by telephone before the home visit how the respective person feels and whether they have possible corona symptoms. On the ground, the trial assistants take on various tasks which they also carry out independently at the sites. These include: bandage replacement, (picture) documentation of the wound development, blood collection, collection of vital signs, and a query about adverse events (AE/SAEs). They also promptly notify the sponsor and the relevant authorities where required. The trial medication will continue to be administered under medical supervision at the trial center.

Keep well.
Florian Schnabel

Clinical Studies with Flying Study Nurses – Part 1: How sponsors can benefit

The following article answers this question. It is the first text in a series of essays that will deal in loose succession with various aspects of the cooperation between Flying Study Nurses and sponsors/clinics.

They work flexibly and on a project-by-project basis; they can implement study projects from start to finish or help with select areas: As external service providers, Flying Study Nurses contribute significantly to the success of clinical study projects. They are often employed in cases where there is no clinical research department in a trial center (or not yet), or when the permanent on-site staff needs active assistance. Florian Schnabel, managing director of Invisio Clinical Studies Consulting, advises sponsors not to regard the additional use of Flying Study Nurses as a pure expense factor per se.

Time saved offers economic advantages

The work carried out by these trained study assistants brings with it economic advantages which quickly amortise the personnel costs incurred. Schnabel cites careful yet fast patient recruitment as one reason for this, as it also leads to fewer screening failures and more included study participants. In addition, the patients cared for by Flying Study Nurses are generally more reliable when it comes to sticking with studies. Florian Schnabel: “Our experience has shown that those involved feel more comfortable and satisfied with their personal care situation with a direct contact person.” The fact that study assistants also act as permanent contact persons for all other project participants and authorities facilitates communication and makes it more transparent.

The managing director of the Mannheim-based study service provider sees further positive aspects in the time savings and smoother project progress. Clinical studies supervised by Flying Study Nurses have often been able to reach important milestones ahead of schedule and were therefore usually completed more quickly. The audits also went according to plan. “By setting up a professional GCP / ICH infrastructure in trial centers, study assistants reduce the number of monitoring by CROs and there are fewer follow-up queries. Since the Flying Study Nurses are specifically trained in advance and work exactly according to protocol, their susceptibility to errors is also reduced,” says Schnabel, whose company supports sponsors as a partner in the search for Flying Study Nurses by arranging and coordinating their services.

Cooperation at an early stage recommended

The point at which Invisio enters a project depends on the respective request by the sponsor. For Florian Schnabel, the best time is before the project has even started – because the earlier Invisio is involved, the sooner the company can make its contribution. In doing so, he is alluding in particular to the collaborative selection of study centers. “We are closely networked with physicians internationally and, thanks to our many years of experience, we know which trial centers are reliable and have good past recruitment figures. When selecting the test centers, we draw on this wealth of knowledge and can thus estimate potential recruitment frequencies in advance,” Schnabel explains. In addition, Invisio cooperates with flying study nurses throughout Europe who are well acquainted with the local conditions and can assess which indicators can be fulfilled at which study centers. A second important point, in his view, is the early coordination of the Flying Study Nurses. This is because finding the right specialists and training them according to the protocol requires an average of one to two weeks’ advance notice.

Unverbindliches Beratungsgespräch vereinbaren

Schedule a consultation

X
X