SIBAmed GmbH & Co KG is a dedicated clinical research site which specialises in Phase II-IV Clinical Studies. Conveniently located in central Leipzig, Germany, a city of 600.000 people, it is near the train station and is easily accessible by public transport. On site parking is also available.
Our team is passionate about clinical research, innovation, and delivering high quality results, while putting our patients first. SIBAmed’s patient-centered-care approach ensures we build a long-lasting rapport with our patients.
As a member of SIGAL SMS Sites Network we join a large community of investigators in Germany.
With over 30 years of combined experience, the team at SIBAmed are committed to providing quality care with a patient centered approach. Our investigators have experience in various indications such as general medicine, cardiovascular, metabolic, orthopedic, women health, hepatology, immunology, and vaccination to name a few. Our highly trained and experienced staff also pride themselves on working efficiently and providing individualized care to our patients.
All of our staff members are GCP certified and partake in regular CPR and First Aid courses. Our study coordinators are also IATA certified.
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SIBAmed study center is fully equipped for the optimal conduction of clinical trials and offering comfortable surroundings for patients, staff and monitors:
- 2 Examination rooms
- 2 Laboratories
- Meeting room
- Monitoring room
- refrigerated centrifuge
- -20°C (= -4°F) freezer
- Dedicated refrigerator for study medication
- Locked storage cabinet for study medication
- secured high speed internet access
- On-site parking
- Good public transport connections
SIBAmed is specialized in clinical trials which can be conducted on an out-patient basis in various indications. An extended subject database and cooperation with external partners for specialist examinations, allows SIBAmed to also expand their area of therapeutic expertise.
- General medicine
- Cardiovascular Disease
- Metabolic disease (Diabetes, Hypercholesterolemia)
- Immunization and Vaccination
- Pediatrics including infants
Our commitment to Quality
At SIBAmed, we understand the importance of providing quality data in a timely manner. Our highly skilled and experienced staff provide clean data with no compromise on patient care. We offer a quick turn-around in data entry time and conduct regular internal checks comparing source data with the EDC. Our team also understands that the right type of patient needs to be recruited to ensure compliance and retention in the study. Our dedication to finding these patients and building rapport leads to high quality data.
Our Standard Operating Procedures (SOPs) and templates have been developed to follow the ICH/GCP and EU Regulations principals. All staff are trained on the SOPs, and they are reviewed on a regular basis. The SOPs are strictly adhered too and ensure our processes are streamlined and efficient.
Internal Audits conducting every two years, support us in the further improvement of the quality and adaptation for the new requests and regulations, if applicable. Furthermore, we recognise the sponsors’ audits as a way to learn and improve.
Recruitment-Diversity is key
The first stage of patient recruitment at SIBAmed starts internally with the extensive databank of patients with varying indications who are willing to participate in clinical trials. The database has been growing organically and we know every patient personally. This individual care is key to the successful recruitment and retention of patients.
We use a modern clinical trial management system (CTMS) to manage the recruitment of the studies and the study specific life of each patient. A quarterly newsletter favors an ongoing relationship with our patients.
Diversity in recruitment sources and ideas are key to a successful recruitment. Together with SIGAL SMS an individual recruitment plan is put together for each particular study. The individual specific study requirements will be taken in consideration. The plan is quickly adjusted as needed depending on the response. This ensures that SIBAmed is able to meet their recruitment goals.
We use a mix of traditional and innovative ways to recruit patients, depending on the indication. For example:
- Partnering with specialists and GPs in and around Leipzig for referrals
- Direct recruitment advertising in newspapers, public transportation, posters
- Online advertising including Social Media in various forms, using online portals
- Organizing information events together with our partnering physicians
- Offering the option of a virtual of telephone consultation to our patients
- Organizing information events about clinical studies
- Quarterly Newsletter to our database patients
As you can see, innovative recruitment leads to successful trials and the achievement of objectives. You can find our success stories here.
Technology – We have a view to the future
SIBAmed recognises that digitalisation is the future of clinical trials and it does not stop at medical study centres. In Germany, we are very progressive as we use the digital possibilities for our studies.
Our site is a trailblazer in Germany having fully implemented a CTMS – Clinical Trial Management System – a system that meets EU privacy and data protection standards and provides all the tools that a study centre needs to conduct clinical trials efficiently. From start-up through to the recruitment to the ongoing phase and the close out, the CTMS has streamlined all our processes and made it easier to track patients and recruitment campaigns, overview retention and keep the team up-to-date with the click of a button.
We are happy to announce that we have also implemented Electronic-source (E-Source). This offers advantages not only to the site but also the sponsors and CROs. CRAs can access digital subject binders for data verification. The web application is specifically built for remote and risk-based monitoring, making it easy-to-use from wherever the CRA is located. E-Source also ensures higher quality data at the site and less room for transaction errors. The system fulfills all specific requirements for the electronic source data systems, according to eSRA.
Our plans to continue in the digitalisation is to implement E-Docs for regulatory binders. Keep checking our website for updates!
SCRS (Society of Clinical Research Sites)
SCRS is an organization which represents the needs of clinical research sites globally. They have over 9000 members in 47 countries.
Unify the voice of the global clinical research site community for site sustainability.
SCRS is an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.
SIBAmed has been an active member since 2017. We regularly attend their summits and engage in the various site advocacy groups. We are proud to be a part of this family and to give a voice to clinical trial site and patients worldwide.
For more Information about SCRS, you can check out their website.
SIGAL Site Management &Support (SIGAL SMS) – Together we are stronger!
SIBAmed is proud to be part of the SIGAL SMS Network.
The team at SIGAL SMS supports our site in everything from feasibility and start-up, to contract management, recruitment support and development, and finally project management. Furthermore, we join a network of over 25 practicing doctors, practice owners and specialists across Germany in the common goal of increasing professionalism, awareness and access of clinical trials.
For more Information about Sigal SMS, you can check out their website.
image source: stock.adobe.com // @fizkes