Clinical Research: Generation and compilation of clinical data through GCP-standard compliant Clinical Trials.
Clinical data are a prerequisite for marketing authorisation
Clinical research is essential basic biomedical research performed to improve medical treatment and is thus also a prerequisite for approval. Therefore, clinical trials must be carried out with subjects to test and scientifically prove the efficacy and safety of medicinal products, medical devices and other treatment methods.
Strict regulations ensure the subject’s health
Preliminary trials are performed to prove that the health risk to which participants will be exposed is low and is outweighed by potential benefits. Before these trials may commence, a positive evaluation by the responsible ethics committee and approval by the federal authorities (BfArM or Paul Ehrlich Institute) are required. Clinical research is subject to numerous national and international regulations, according to which all trials must be conducted. These include the AMG (Medicines Act), MPG (Medical Devices Act) and the Declaration of Helsinki, GCP (Good Clinical Practice). A multinational research team including a range of experience and perspectives is beneficial, particularly as projects often involve several countries, each of which have different regulations which must be taken into account. In these cases, the European Clinical Research Infrastructure Network (ECRIN) provides support.
During clinical trials, the credibility and comprehensibility of all findings, observations and conclusions are critical. After all studies have been completed, an application for marketing authorisation is submitted to the competent regulatory authority.
In summary, the term clinical trial refers to any investigation conducted in humans to investigate or demonstrate clinical, pharmacological and/or other pharmacodynamic effects of investigational medicinal products and/or to determine any adverse reaction to investigational medicinal products and/or to investigate the absorption, distribution, metabolism and excretion of investigational medicinal products, to ascertain their safety and/or efficacy.
This includes clinical trials conducted in one or more investigational sites in one or more countries.
Generation and compilation of clinical data through GCP-standard compliant Clinical Trials:
There is currently no satisfactory therapy available for a large number of diseases. Drugs and medical devices are tested in clinical trials for their efficacy and safety. However, since the cost-benefit analysis of innovation is also of importance in addition to these medical aspects, a pharmacoeconomic evaluation is also relevant at this stage.
We have many years of experience in coordinating and conducting phase I-IV clinical trials in various therapeutic areas.
Mediconomics takes care of your clinical study entirely or in parts.
For instance: application, project management, monitoring, statistics and preparation of the final report.
Our multinational team assists you throughout study design and conduct, ensuring the highest quality data are obtained. Furthermore, we are specialists in the supervision of essential post-marketing studies, including PASS and NIS. In addition, we are proud to be listed in the BIOCOM directory and work closely with the Research Association of Drug Manufacturers (FAH) and the Institute of Clinical Research.
Our clinical research services include:
- Design development
- Application process
- Project management
- Site management
- Regulatory support
- Preparation of the final report
FAQ – frequently asked questions
What are the benefits of collaborating with Mediconomics in clinical research?
Mediconomics provides access to extensive expertise, infrastructure and resources required to conduct clinical trials. We can assist with study design, participant recruitment, data management, regulatory requirements and much more.
What clinical trial phases can Mediconomics cover?
We can cover all phases (Phase I-IV) of clinical trials, including planning, execution, monitoring, data analysis and reporting. According to the requirements of the respective studies, it is also possible to support only certain areas, such as project management or monitoring.
Can Mediconomics assist with regulatory processes related to clinical trials?
Yes, we can also support you with submitting approval applications and regulatory procedures around clinical trials. We hold extensive expertise in the regulatory area (cf. Regulatory Affairs).