tecurat GmbH – Knowledge of the industry for the industry
We will show you how to utilize the information from prior clinical applications in the early stages of development to maximize the overall benefit for the patient.
We give you tips on how to take your medical devices in the field more into account in post-market surveillance planning, and how to score successfully in risk management.
We are ready to help you find the right study design for your clinical trial, and support you with the necessary documentation requirements in your role as a sponsor.
Your innovative product is already being planned, but an opinion of clinical experts is still pending?
You need orientation for clinical trials, PMCF or the right strategy for your post-market surveillance reports?
The application of quality & risk management in the context of clinical trials is still foreign to you for the time being?
Are you not yet familiar with these topics in connection with clinical data or do you have other concerns in terms of clinical affairs? Then make an appointment with us.
Much more
The field of clinical affairs encompasses so much more than the consideration of the regulatory requirement of a clinical evaluation & trial.
Medical expertise
Already with the emergence of the first product idea, you as a manufacturer should always consider your medical device from the perspective of the risk-benefit analysis of your future patient population. Thus, clinical expertise comes into play for the first time with the definition of the intended purpose. Even if the intended purpose is usually formulated unspecifically and rather vaguely, a sufficient medical understanding of the respective indication is indispensable.
Clinical benefit
The decisive factor for the approval and placing on the market of your product is the scientifi-cally valid proof of a clinical benefit with a balanced risk/benefit ratio for the patient.
Ethics and Standards
Every direct patient contact as well as scientific examination on humans must be carried out in strict compliance with the ethical & clinic-related regulations.
The massive cornerstone of any medical inter-vention. These likewise include the product-related stand-ards of quality & risk management.
Feedback & suggestions for improvement
And even after the marketentry of your medical device, the cooperation & voice of the clinical experts is relevant – for example in planned PMCF studies, or the risk assessment after safety feedback from the field, when it is neces-sary to assess and control patient impairments through risk-minimizing measures.
We convene medical expert committees with you to discuss all emerging questions about risks and benefits for the patient.
We prepare the clinical evaluation with the associated accompanying documents for you and determine all available sources of information.
We stand ready to show you how risk man-agement also applies to your clinical trials, taking into account the applicable standards.
We train you on the ethical & normative standards which have the highest priority in the execution & planning of your clinical trial.
We accompany you in setting up your PMCF study for your existing products and support communication between stakeholders.
Together with you, we develop a concept on how to proactively generate clinical data with your medical devices already at the customer's premises.
We are happy to be there for you
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!
+49 331 600 87 640
+49 331 600 87 640
