Advanced methods of case number calculation
Case number planning, which is calculated to match the study design, is an important success factor for precise study results. Our colleague Christiane Lober has studied the methods.
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Your team is always there for you
You can do clinical research alongside your day-to-day clinical work.
Your project starts
We work with you to produce all the relevant documentation that needs to be submitted for the required testing procedures.
We support you and, if you wish, we can manage your communications with ethics committees and the relevant national competent authority (e.g. BfArM in Germany) for you.
Your team is ready
Your team brings together specialists who have a thorough understanding of the details and generalists who are good at keeping an eye on the big picture.
Your team combines lots of talent, experience and knowledge. When everyone works together, the study will be a success.
Everything under control
Our project managers guide your study for you. They manage your research every day. They maintain an overview of the big picture and notice any unexpected events. Even when everything has been carefully planned, things doesn’t always go according to plan. Your team will be prompt and flexible in discussing the measures that are necessary to get your study back on track with you.
You will receive status reports from us and interim results that document the successful progress of your study.
Clinics - the pillars of your research
We maintain contact with the study centres for the entire duration of your study. We take care of the contracts, remuneration and all the formalities.
We monitor patient inclusion, chase things up and provide that bit of encouragement if the number of participants is lower than expected.
Our monitors are there for you at the study centres. They train the staff at the study centres and help the study assistants to gain an understanding of the specific requirements of your study. They make the centres aware of the details of your study and the quality of your data.
Patients are the key to success
Up to five years after inclusion, we telephone patients to collect data for your study and provide you with information about the long-term success of a treatment.
At 95 per cent, our follow-up rate is far above average. Our patient service employees are helpful to the patients. They ask the patients questions in an empathetic and precise manner and this allows them to obtain results for long-term observation within the scope of your study.
Services
Centre support
Centre contracts
Steering Committee meetings
Site qualification
Risk-based monitoring
CEC Clinical Events Committee
DSMB
Investigator meetings
Status reports
Remote monitoring
On-site monitoring
Site allocation
Remuneration
Monte Carlo simulations
Project Initiation
Project Management Plan (PMP)
Safety Management Plans
Monitoring plans
News
We say THANK YOU for the good cooperation in 2019.
"Medicine should not only give years to life, but also life to the years." Georg Christoph Lichtenberg
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First milestone in five months
The study protocol has been released and submitted to the Ethics Committee. The first trial phase of PASSPORT-HF is almost completed.
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