Finding the right solutions is our business. When it comes to regulatory matters, you can benefit from Ethicare’s experience and outstanding expertise. We are proud of our Regulatory Consulting services and are ready to assist you in creating and following a strategy for success. Ethicare’s team of scientific, regulatory, clinical and biostatical professionals possess the experience, insight and knowledge necessary to help you reach strategic milestones.
Do it right the first time!
This is a routine of the Ethicare experienced clinical trial submission team. The team provides regulatory compliant quality application dossiers for the conduct of a clinical trial to be submitted to the competent authorities and the applicable ethics committees. The team is dedicated to ensuring the completeness and accuracy of your submitted information and of the necessary supportive documentation for the demonstration of quality, safety and efficacy of your investigational medicinal product or medical device and the conduct of your planned trial.
Of course, we can also assist you with any amendments to your trial as well as inform all necessary parties about the end of the clinical trial.
The Ethicare team supports you with negotiations and answering questions from competent authorities and ethics committees concerning your clinical trial project.
Ethicare’s consultant statisticians understand the balance between clinical science, sound methodology and financial constraints and can determine a statistical concept for your clinical trial that is suitable for all questions you wish to answer. We can help you avoid needless complexity, errors and excessive cost.
Armed with a high level of competence, the best available and independent scientific knowledge, independence and total transparency, Ethicare will stand by you and support your research.
Our common goal in clinical research is the protection and safeguard of trial subjects’ rights, safety and well-being. Benefit from Ethicare’s expertise in protocol design, patient information and informed consent processes that promote fast reviews by ethical and regulatory bodies.