Cooperation with DREHM Pharma
Clinical studies and more…
No matter whether a new drug or medical device is to be established on the market or its efficacy and safety are to be kept in mind – evidence-based knowledge of the clinical data situation is the basis for responsible decisions in the health industry.
This requires not only broad theoretical knowledge, but also experience in dealing with everyday problems and stumbling blocks. Sounds like an overwhelming challenge? Not with the right partners at your side!
Through our cooperation with DREHM Pharma, based in Vienna and its dedicated team of experienced specialists, we can offer you tailor-made support and solutions for all requirements.
In the following areas CW-Research & Management and DREHM Pharma offer bundled competence from a single source:
Approval and market introduction
Even the best registration documents must be backed up with high-quality clinical data. Our partnership offers the best basis for a successful launch. We will be happy to help you prepare the necessary documentation for a successful approval procedure and a sustainable market launch.
Clinical drug and medical device studies
Efficient and reliable study management, from planning through execution to completion, is essential for success. We support you in study planning, preparation of study-specific documents as well as study monitoring and evaluation – from Phase I to Phase IV.
Non-Interventional Studies (NIS)
Outstanding quality in planning and execution is decisive for the significance of the results. You will receive complete support from us, from communication with the authorities and the ethics committee, through concept development and distribution of the study documents, to printing and publication.
Marketing / Scientific Positioning
Optimal preparation for market launch is a prerequisite for successful product establishment.
Based on the clinical data, we can enable an appealing scientific positioning of the product so that you can create advertising with recognition value for doctors, pharmacists and patients. We are happy to assist you with these measures as well as with all marketing-relevant topics.
Data management and biometrics
Good and reproducible results from statistical evaluations can only be achieved with a solid and high-quality database. Biometrics creates groundbreaking statistical correlations.
We offer support in the field of data collection and processing and work with you to develop an efficient concept for database creation and quality assurance.
Whether in a scientific publication or in presentations for the general public – the comprehensible communication of scientific facts can be decisive for the success of a product. We are happy to supervise all related processes, from data review and statistical evaluation to communication with publishers and reviewers. Also here, quality is always the main focus of our actions.
Continuous monitoring of the clinical data situation
Even after approval, our cooperation enables us to continuously improve the efficacy and safety of your products. With our expertise in conducting Phase IV studies as well as systematic literature research and case processing, we offer you high-quality all-round support.
Even before a drug is launched on the market, it is essential to record and report adverse drug reactions accurately and in a timely manner. Even after that, we provide a proven vigilance system with all necessary structures and resources of all kinds, such as a QPPV and 24-hour availability for adverse reaction reports.