Go ahead for PASSPORT-HF by ethics committee
The ethics committee has evaluated the clinical investigation plan and has provided favourable opinion for the PASSPORT-HF study without further requirements.
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Let our team help you turn your idea into a successful study.
Kick-off
Regardless of how much you have already developed your idea or whether it is still in the initial planning stages, we sit down with you and work together to develop your idea. You contribute your expertise and we use our experience to guide you.
Your concept
We work together with you to turn your idea into the concept for your study. In collaboration with you, we define the scientific, methodical and statistic requirements for the study protocol and plan a schedule for the study that can be reliably implemented.
We work together to establish criteria for patient safety. We discuss what data is necessary for your study and develop the right case report form for you with our EBogen software. This means that you obtain clear and valid data for your research.
Monte Carlo
We determine the expected duration of the study according to your requirements. We work with the study centres to establish the realistic number of patients you can expect for your study.
Using the Monte Carlo simulation, we use a number of different possible study scenarios to calculate the number of patients that can be reliably expected over the course of your study on a statistical basis.
You receive a model that illustrates patient inclusion and also takes into account the deviations that can occur in any study.
Budget and financing
We will use your concept as the basis for creating a transparent and viable time and cost schedule that can be used to win over potential donors. If you wish, we would be happy to help you with this.
Services
Feasibility studies
Submission to ethics committees
Disease Register
Medical Devices Act (MPG) Sections 20-23a
Randomisation concepts
Observational Studies
Non-interventional studies
Budget Estimates
MPG Section 23b
Interventional Studies
Post Authorisation Safety Study
Federal Institute for Drugs and Medical Devices (BfArM) & Paul Ehrlich Institute (PEI)
Observation plans
Study Protocols
Comparative studies of strategies
Synopses
MPA (Medicinal Products Act)
Federal Office for Radiation Protection (Bundesamt für Strahlenschutz)
News
First COVID-19 Registry in Rhineland-Palatinate, Germany
Supported by the Ministry of Social Affairs, Labour, Health and Demography of Rhineland-Palatinate, IHF GmbH manages the COVID-19-Registry Rhineland-Palatinate, which was launched this weekend. Registry for Rhineland-Palatinate for the documentation...
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Benefit assessment of an innovative medical device: A study commissioned by the Federal Joint Committee (G-BA)
Commissioned by the Federal Joint Committee (G-BA), IHF GmbH is running one of the first studies on benefit assessment of a medical device in accordance with the directive § 137e Social Security Code Book V (SGB V).
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