Germany is repeatedly number 2 worldwide in the number of clinical trials initiated by industry. Well over 500 studies are initiated in Germany every year. The front-runner is Berlin, almost 50% of the studies in Germany are conducted at medical institutions. Special attention is paid to the Charité, which is one of the 5 best hospitals in the world. The majority of the studies are conducted internationally and confirm the outstanding cooperation with research partners and clinicians e.g. in China. In addition to the research landscape, Germany is also an established innovation location. In 2018, > 47,000 patents were registered. MEDIACC helps to make ideas available to patients through clinical studies by initiating studies for internationally operating partners. We are proud to do our part.
Today is the first World Patient Safety Day worldwide. In order to protect the safety and the best interests of patients in clinical studies, we implement the highest ethical standards and the appropriate regulations in all our studies. This is how we gain the trust of our customers and patients, even when conducting clinical studies with children. Recently, MEDIACC submitted a comprehensive ethical application for a study with an innovative medical device with professional athletes. By carefully choosing the endpoints and intensively training the study centres we can make sure that the study conduct will be performed according to the highest safety standards.
Since its foundation in 2013, MEDIACC has been continuously growing. During our successful work on preclinical and clinical studies, including observational studies and the reimbursement of medical apps, we were able to welcome new employees and thus slowly exceeded our old office capacity. We, furthermore, expanded our sphere of activity. As of August 26, 2019, our base is located at
– very close to our old location, right in the middle between the underground stations Berliner Straße and Güntzelstraße.
Immediately on the first day after the move, MEDIACC resumed its work. Our service for you in the new environment will not only remain at the same superior level, but will even improve from now on! Having been committed to excellence for many years, MEDIACC will continue to assist you with all questions and problems related to the ever-growing healthcare market.
We look forward to welcoming you at our new place of action!
MEDIACC is well prepared for the implemementation of the European Medical Device Regulation (MDR 2017/745) for Clinical Evaluations, Clinical Studies, Post-Market Clinical Collow-up (PMCF) and Post-Market Surveillance (PMS).
Time flies for manufacturer of medical devices and developers of medical apps. The EU MDR 2017/745 will be applicable on May 26th 2020. Transitional arrangements are put into place by the Notified Bodies. However, for medical devices requiring Clinical Studies, the MDR is binding in case last patient / last visit is not finished by this date.
MEDIACC’s employees now received the certificate on Clinical Evaluation and Clinical Studies according to EU MDR 2017/745 by Germany’s first and only designated Notified Body for EU MDR, TÜV Süd. As certified partner on the side of our clients, we make sure to striktly comply with international standards such as the Declaration of Helsinki, Good Clinical Practice (GCP) and ISO 14155:2011 as well as implement necessary changes as mandated by the new regulation to protect patients’ rights and safety and increase medical device effectiveness in the EU market.
An interesting feature in our view is that the Medical Device Regulation contains words such as “Safety”, “Clinical Data”, “Clinical Evaluation” and “Post Marketing Surveillance” are at least seven time more often than in the Medical Device Directive (MDD 93/42/EEC).
Data of 31 patients have been used in an international paediatric clinical evaluation for an innovative assistive medical device to show improved clinical outcome (94% of users) when used in addition to standard therapy. Thanks to the proficient cooperation with our university partners and clinical experts, quality of data was first-rate due to meticulous attention to details and expert knowledge. In short time, results could be published in a highly ranked free full-text peer-review journal to change therapeutic perspective for people with physical disabilities.
Our special thanks go to our patients and their families who gave their consent for their data being used – thank you!
The Berlin University Alliance, including the Charité, has won the Excellence Initiative for top university research. The German government will provide an additional 200 million Euros over the next few years to support excellent university facilities for outstanding research projects.
We congratulate all stakeholders and our cooperation partners on this great success. The funding will enable to further develop the cooperating university locations and Berlin as a top international science location.
The proof of safety and efficacy of innovative specific biopharmaceuticals according to the specifications of the Chinese National Medical Products Administration (NMPA, Chinese: 国家药品监督管理局) are subject to the requirements for clinical trials according to the regulations of the German Medicines Act and approval by the European Medicines Agency (EMA) before they can be transferred to the European market. The exact analysis of the existing work was subject of intensive and harmonious discussions before the conception of a clinical trial in Europe can begin.
We were invited to enable excellent scientific experts to start their clinical studies in Europe in 2 spin-offs from a very renowned Chinese university and supported them with the first operative project phases.
Of the new drugs coming onto the market, one in four costs more than € 100,000 per year.
The analysis of the benefit assessment according to the Drug Market Restructuring Act (AMNOG) has been in place since 2011. The fifth AMNOG Report from 2019 discusses the extent to which the high annual therapy costs of newly approved active substances can be further taken over by the insured community. In addition to data on survival chances, pharmaceutical companies are required to present high-quality data on patients‘ quality of life for all indications in order to assess the additional benefit.
This ongoing development of the benefit assessment by the authorities, G-BA and IQWiG, related to this endpoint calls for the design and conduct of clinical trials with precisely fitting and objective endpoints. This is one of our main strengths.
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