| Title | Address | Description |
|---|---|---|
LMU | GESCHWISTER SCHOLL PLATZ 1, 80539 München, |
|
Fundació Clínic per a la Recerca Biomèdica | Carrer del Rosselló, 149, 08036 Barcelona, Spanien |
|
Helmholtz-Zentrum für Infektionsforschung GmbH (HZI) | Ingolstädter Landstraße 1, 85764 Oberschleißheim, Deutschland |
|
Helmholtz Munich | Inhoffenstraße 7, 38124 Braunschweig, Deutschland |  |
Medizinische Hochschule Hannover | Carl-Neuberg-Straße 1, 30625 Hannover, Deutschland |
|
NIMR-Mbeya Medizinisches Forschungszentrum | Hospital Hill Rd, Mbeya, Tansania |
|
Technische Universität München | Arcisstraße 21, 80333 München, Deutschland |
|
UNIVERSITY COLLEGE LONDON (UCL) | GOWER STREET, WC1E 6BT London |
|
Klinikum Rechts der Isar der Technischen Universität München | Hörsaal A, Klinikum rechts der Isar, Ismaninger Str. 22, 81675 München, Deutschland |
|
UKE Hamburg Eppendorf | Martinistraße 52, 20251 Hamburg, Deutschland |  |
Azienda Ospedaliero- Universitaria di Parma | Str. dell'Università, 12, 43121 Parma PR, Italien |  |
Universitätsklinikum Leipzig | Ritterstraße 26, 04109 Leipzig, Deutschland |  |
Barts Health NHS Trust | Co-operative Bank Plc, 9 Prescot St, Whitechapel, London E1 8AZ, Vereinigtes Königreich |
|
Royal Free London NHS Foundation Trust | Pond St, Hampstead, London NW3 2QG, Vereinigtes Königreich | |
PNO Innovation GmbH | Oskar-von-Miller-Ring 29, 80333 München, Germany |
|
SocraTec R&D GmbH | Im Setzling 35, 61440 Oberursel (Taunus), Deutschland |  |
Universitätsklinikum Frankfurt | Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Deutschland |
|
SocraTec R&D GmbH
General Information
SocraTec R&D GmbH is a full-service contract research organisation (CRO), professionally conducting clinical studies since 1998. They operate their own state-of-the-art Clinical Pharmacology Units (CPUs) dedicated to clinical conduct of early phase trials in healthy subjects and patients. The SocraTec R&D team, based in three locations in Germany, is specialized in clinical research solutions in early and late phase drug development. They provide the full range of clinical research services to the pharmaceutical, biotechnology, and medical device industries and manage and conduct clinical studies from the first application in humans, through proof-of-concept in the patient population, to efficacy studies in the late stages of clinical testing.
Services include scientific consultancy by leading experts for study design development, scientific advice and expert statements, clinical conduct of studies phase I-IV, quality assurance, monitoring, data management, biostatistics and pharmacokinetics, medical writing and pharmacovigilance.
To date, SocraTec has conducted several hundred Phase I trials, including first-in-human and vaccination studies, as well as studies assessing bioavailability (how drugs are absorbed and used by the body) with various dosage forms and delivery methods, such as tablets, injections, and transdermal patches. Their expertise covers clinical testing of small molecules as well as biologics.
With their substantial expertise in conducting both national and international trials, SocraTec R&D is committed to supporting the TherVacB project and advancing innovative treatments for hepatitis B.
SocraTec R&D GmbH
Headquarters
Im Setzling 35
61440 Oberursel
Germany
link
Role in TherVacB
SocraTec R&D plays a vital role in the TherVacB project by managing and executing the clinical trial. They oversee the clinical trial management and monitoring, ensuring professional organization and conduct of the trial through on-site visits that confirm data accuracy and compliance. Additionally, the project management group of SocraTec R&D manages regulatory submissions and approvals in both the EU and UK, ensuring all submissions meet legal and ethical standards. The team coordinates the clinical project by facilitating collaboration, tracking progress, and addressing challenges. Moreover, SocraTec R&D is in charge of reporting, which includes writing the Clinical Study Report and preparing a layperson summary to make the results accessible to both professional researchers and the public.
Project Staff
André Warnke
Managing Director
He is a pharmacist with extensive expertise in clinical research and trial management. André Warnke joined SocraTec R&D in 2004 as a project manager, playing a key role in expanding the company’s clinical trial portfolio. In 2012, he became a management board member and managing director. His expertise spans trial design, conduct, monitoring, and reporting, with a focus on respiratory diseases, ophthalmology, gynaecology, oncology, pain management and nephrology.
Maria Anschütz
Head of clinical project management
She is a pharmacist and clinical research expert with extensive experience in early-phase trials. Maria Anschütz leads the department of project management for clinical trials at SocraTec R&D, ensuring compliance and high-quality execution. With a strong background in regulatory processes, she oversees trial conduct, documentation, and reporting. For the TherVacB project, she is responsible for project management, regulatory and coordinating trial execution with her team of project managers and assistants.
Sarah Spriestersbach
Head of clinical monitoring
She is a pharmacist with expertise in clinical trial management and monitoring. Sarah Spriestersbach joined SocraTec R&D in 2021 and became head of the monitoring division in 2022, overseeing the team of monitors. She has experience with mono- and multicentre trials, medical device studies, and virtual trials. For the TherVacB project, she contributes her expertise in project management and monitoring to ensure high-quality trial execution.