Good Clinical Data Management Practices The Society for Clinical Data Management released the revised Data Management Plan (DMP) of the Good Clinical Data Management Practices (GCDMP©). The aim of the revision was to synthesize an evidence-based best practice for data management in clinical studies based on literature research as well as practical experience. Given the importance of [...]
Alzheimer's & Brain Awareness Month This month we want to continue to take time to have conversations and spread awareness about the brain and the some of the diseases that affect millions around the globe. For starters, did you know that Alzheimer’s is the only leaading cause of death that cannot be prevented, cured or even slowed at [...]
Get eCRF data with InSIGHT CTMS’ new flexible data import We are proud to announce a new feature for importing external data into our clinical trial management software, InSIGHT. Information, such as subject recruitment data from any Electronic Case Report Form, can now be continuously imported into InSIGHT in any desired time interval. This new addition [...]
Collaboration without limits with our InSIGHT During this difficult time due to the COVID-19 pandemic, SCOPE is taking the necessary safety precautions to safeguard the well-being of trial participants, site teams, and our employees. As our employees have shifted to a home-based working environment, SCOPE’s successful business contingency plan is in large part due to our CTMS [...]
SCOPE is now a member of the BioRN Network SCOPE International AG is proud to announce the membership with BioRN, the science and industry cluster of the Rhine-Main-Neckar region around Heidelberg, one of Germany’s strongest biotech hubs. BioRN is a non-profit network fostering health innovations and serving its members by creating a rich translational ecosystem as [...]
Promising development for clinical studies in Romania The National Agency for Medicines and Medical Devices of Romania (NAMMDR) is established by reorganization of the former National Agency for Medicines and Medical Devices (NAMMD). By strengthening the status of national competent authority in the field of human medicine and medical devices, while operating with an ethical and [...]
FDA Approval for oral contraceptive – teamwork to success SCOPE International AG announces that The US Food and Drug Administration (FDA) has approved the new drug application (NDA) of an oral contraceptive for pregnancy prevention that was developed by one of our clients. SCOPE played a major role throughout the developmental process. The entirety of this [...]
SCOPE International announces successful FDA inspection SCOPE International AG is proud to announce that its subsidiary in the United States, SCOPE International USA, Inc., was successfully inspected by the US Food and Drug Administration in June 2019. The outcome of this FDA inspection is the most recent example of the high-quality results produced by the SCOPE [...]
Spotlight on our Biostatistic expertsand strategic consulting team SCOPE International AG is pleased to announce the appointment of Björn Boße as new head of biostatistics. Together with Dr. Klaus Junge as Senior Biostatisticial Advisor SCOPE International offers an exceptional expertise in biostatistics. Björn and Klaus have both more than 20 years of experience in the pharmaceutical [...]
Adam Braithwaite appointed to the Business Development Team for the US SCOPE International AG is pleased to announce the appointment of Adam Braithwaite as the key contact for Business Development in the US. Adam will join the SCOPE BD team as part of its North American subsidiary, SCOPE International USA, based in Pittsburgh, PA. In his [...]
