Core business of MedicalSyn is the development and operation of medical EDC-systems as well as associated eCRF and database solutions. The databases and registry systems developed and operated by MedicalSyn currently document more than 6,000 patients in national and international projects. The Center for Clinical Neurosciences of the University Hospital Carl Gustav Carus at TU Dresden and the Carl Gustav Carus Management GmbH c/o University Hospital Dresden commissioned MedicalSyn with the technical operation and support of the MSDS3D system. In addition, MedicalSyn has long-term experience in development and operation of tablet-based survey systems for medical-clinical care situations as well as in clinical trials.
MedicalSyn is characterized by a long history of developing and operating clinical eHealth solutions to sustainably support the use of digital technologies for prevention, diagnosis, treatments and healthcare monitoring. The shift from paper documentation to user-friendly electronic acquisition tools provides the ability to simplify clinical practice for patients, physicians and healthcare professionals. With the help of automated calculations, faster availability of results can be achieved and the threshold for the systematic application of established examination methods can be lowered. Suitable computer-aided systems for disease management and monitoring of patients can dynamically display individual patient histories and represent them consistently over many years.
MedicalSyn offers services in the sector of data management. These services include all processes of collection, management and use of medical data from clinical trials as well as medical-clinical care projects. To provide the best possible data quality and a valid database for the evaluation, the individual service areas of data management result in:
- Preparation, implementation, execution and monitoring of data management in clinical trials and medical-clinical care projects
- Creation and review of essential documents
- Data cleaning in terms of query management
- Survey Management
- Coding according to MedDRA and WHO-DD standard
- Contribution towards the continuous improvement of data management processes in accordance with applicable guidelines and standards.
MedicalSyn offers pharmacovigilance services with the objective of supporting risk management during the use of pharmaceuticals. The services of safety management include, among others:
- Preparation and / or review of study-specific documents (Safety [Management] plan, [S]AE-registrations etc.)
- Electronic / digital acquisition of (S)AE messages
- Automatic sending of (S)AE messages in formats specified by the sponsor (e.g. E2B)
- Data screening on safety-relevant aspects within specified deadlines
- Generation of safety listings according to the requirements of the client
- Coding of adverse events according to MedDRA