During this difficult time due to the COVID-19 pandemic, SCOPE is taking the necessary safety precautions to safeguard the well-bring 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 system, InSIGHT, a centralized cloud-based environment which allows for remote access and thereby location independent working. Our teams continue to be available and provide the level of quality and collaboration our sponsors and partners have come to expect.
Pavla Rozmarová, Regional Office Director for SCOPE International Czech Republic, recently engaged with Pharma Boardroom to speak about the shifting clinical landscape in the Czech Republic. Positioned in a life sciences hotbed in Prague, the office has embraced new technologies and forward thinking that will allow them to stay in the forefront of the evolving clinical industry in the Czech Republic and the CEE region.
NewsSCOPE about the Czech clinical research landscape
We are excited to announce that SCOPE will be will be attending and exhibiting at the Outsourcing in Clinical Trials DACH 2019 in Munich, Germany from October 9-10. We welcome you to visit us at Booth #9 to learn more about our company and our experience.
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 well as promoting, representing and connecting the regional innovation stakeholders.
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 civic sense to ensure that all Romanian patients have access to innovative treatments, the new direction of the Agency will focus on the following aspects:
NewsPromising development for clinical studies in Romania
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 endeavor involved 10 years of collaboration with the sponsor over 8 projects using 250 clinical sites where 5000 subjects were enrolled. SCOPE conducted dose finding studies, multiple phase II trials, and the phase III program in both Europe and the US.
NewsFDA Approval for oral contraceptive – teamwork to success
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 team. Our clients can focus on the science of product development, while trusting SCOPE to follow the regulations and remain inspection ready at all times. Since the foundation of SCOPE in the year 2000, the company has successfully completed multiple FDA, EMA, and BfArM company inspections, along with countless inspections of sites that were a part of SCOPE clinical trials.
NewsScope International announces successful FDA inspection
We are excited to announce that SCOPE will be participating in the 9th annual Outsourcing in Clinical Trials Europe 2019 in Milan, Italy. Our Head of Biostatistics will give a talk titled „Efficiency through Quality by Design – How QbD will help in defining your outsourcing strategy”.