The Clinical Development team develops new therapeutic strategies for the treatment of diseases, especially in indications with a high medical need. The experts of this team understand the importance of clinical investigations for the effective introduction and acceptance of new therapies. They manage and monitor all medical aspects of MorphoSys’s compounds in clinical trials, including the development of study protocols and reports. They also assess the potential development of an area of research.
Clinical development expertise
The department for Drug Safety and Pharmacovigilance is responsible for the collection, detection, assessment, monitoring and prevention of adverse events in clinical trials which are sponsored by MorphoSys. Adverse events are unwanted effects which may be caused by taking a drug. Drug-related side effects can be mild, such as a stomach ache or drowsiness, and go away after you stop taking the drug. Others can be more serious or even life-threatening. Through a concise and rapid exchange of safety information among all parties, our safety and surveillance experts identify potential hazards associated with pharmaceutical products and minimize the risk for patients when taking part in a clinical trial.
The Regulatory Affairs team manages all aspects of MorphoSys’s proprietary development programs that are relevant for their admission to clinical trials in the EU and US. They develop the approval strategy for our compounds with a focus on expedited programs and are responsible for its implementation in all proprietary development programs. Furthermore, this team has comprehensive knowledge of the interpretation and implementation of relevant policies and increasingly complex registration requirements.
The Quality Assurance department is responsible for the implementation, oversight and continuous improvement of a quality management system covering relevant aspects of good clinical practice (GCP), good manufacturing practice (GMP) and good laboratory practice (GLP). Quality Assurance provides advice and support for the quality management system that is in place, ensuring compliance with applicable laws, regulations and guidelines as well as a constant high quality for the whole development process.