Das CTC North spricht auf dem secuTrial®-Anwendertreffen & Symposium am 27. & 28. Mai 2021.
Unsere Kolleginnen Noelia, Aylin und Nicole berichten über erste Erfahrungen bei der Durchführung von Covid-19 Studien mit secuTrial®.
Mit Ende der Übergangsfrist für die europäische Medizinprodukteverordnung und dem nationalen Medizinproduktedurchführungsgesetz am 26. Mai 2021 steigen die Anforderungen für Hersteller immens.
Für die Generierung hochwertiger Daten ist das CTC North ein kompetenter und erfahrener Partner in allen Phasen der klinischen Prüfungen und Studien.
Wir werden voraussichtlich im Juni einen Online MPG-Ergänzungskurs anbieten. Den finalen Termin geben wir schnellstmöglich bekannt.
Sie können sich gerne bereits jetzt per E-Mail beim Team Training Coordination vormerken lassen:
Hier geht es zur Pressemitteilung des Universitätsklinikums Hamburg-Eppendorf:
BOSTON and DURHAM, N.C. – Nov. 23, 2020 — Parexel, a leading provider of solutions to accelerate the development and delivery of innovative therapies to improve world health, from clinical through commercialization, today announced a strategic partnership between its Early Phase Clinical Unit (EPCU) in Berlin, Germany and Clinical Trial Center (CTC) North, a full-service CRO located at the University Medical Center Hamburg-Eppendorf (UKE).
The strategic collaboration supports the high demand for and continuation of Early Phase clinical studies during the COVID-19 pandemic, enabling the optimal use of resources and providing additional bed capacity for healthy volunteers and patients ensuring early phase research can continue. One central point of the collaboration will be the roll-out and implementation of Parexel’s eSource system ClinBaseTM at CTC North to drive efficiency and collaboration.
“We’re delighted about the CTC North partnership, which leverages broad expertise across both partners to provide a unique solution for Clinical Pharmacology research in healthy volunteers and patients,” said Dr. Sandra Stark, Head of the Berlin EPCU & Interim Head, Global EPCUs. “The use of ClinBase as the eSource system will support trials from a data perspective resulting in minimal timelines for post-clinical services.”
Multiple ongoing and recently awarded studies are being conducted at CTC North as well as biosimilar, COVID-19, food effect and bioavailability studies, among others. CTC North and its Clinical Pharmacology Unit have partnered with UKE for more than 10 years, primarily in the conduct of vaccine development and first-in-human trials.
“We’re pleased to have the opportunity to partner with Parexel’s Berlin EPCU after collaborating together for many years,” said Ralf Freese, Medical Director and Vice President of BVMA (Federal Association of Contract Research Organizations). “Under one roof, we’re combining Parexel’s ‘excellence’ with CTC North’s access to one of Europe´s most modern clinics at UKE providing access to specialists from all fields of medicine.”
In addition to its Berlin EPCU, Parexel’s Early Phase clinical development presence includes EPCUs in Baltimore and Los Angeles (USA) and London (United Kingdom), providing access to more than 300 beds and 35+ patient populations. This global network enables customers to run Phase I trials from multiple locations simultaneously with integrated technology to make decisions in real-time. During the COVID-19 pandemic, Parexel has adapted its Early Phase facilities and processes to mitigate viral transmission risks. Each of the company’s units can support COVID-19- related product development and flexible capacity models and decentralized clinical trial processes have been introduced where possible to help advance Early Phase programs in support of COVID-19 therapies.
Parexel supports the development of innovative new medicines to improve the health of patients. We provide services to help life science and biopharmaceutical clients everywhere transform scientific discoveries into new treatments. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned
by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.
About CTC North
CTC North is an independent full-service CRO located at the University Medical Center Hamburg-Eppendorf (UKE). Its objective is to guarantee the professional conduct of clinical trials in accordance with ICH-GCP, the German Drug Law (AMG) and the German Medical Device Law (MPG) within a university environment. CTC North provides professional services in all aspects of clinical trials and offers complete clinical trial management complying with regulatory guidelines valid worldwide and the highest quality assurance standards. It acts as an advisor to investigators and scientists and provides a variety of support services related to conducting clinical trials. CTC North has extensive experience with the coordination of multicenter clinical trials, with a focus on studies with non-commercial sponsors (IITs). The following services are provided: Project management, regulatory services, medical writing, safety monitoring, monitoring, data management, and statistics.
Hier geht es zum Interview mit Prof. Marylyn Addo (UKE) und Dr. Saskia Borregaard (CTC North).