CRS Mannheim is the largest of all CRS units with, at its core, a clinic with three distinct wards of twelve high-care beds each, plus a total of 50 long-term stay beds, all separated over two main floors. Together with its multifunctional rooms, its separate 800 sqm outpatient area and its large garden, this CRS unit is well set to be the most versatile unit in response to ever challenging trial designs.
The hospital-like unit of CRS Mannheim looks back onto a long-standing track record having carried out the entire spectrum of phase I and phase II clinical trial challenges, while always adhering to the highest quality standards. This covers a vast range of trials, from first-in-human (FiH) (in the areas of, e.g., cardiovascular, central nervous system, dermatology, acute respiratory distress syndrome – ARDS, pain – including narcotics) to selected proof-of-concept (PoC) (phase IIa) trials.
Exceptional CRS expertise lies in cardiometabolic trials (clinical research on obesity, diabetes, metabolic and cardiovascular diseases) with a broad spectrum of clinical methods for the pharmacodynamic (PD) assessment of investigational products.
Historically, today’s clinic of the CRS Mannheim unit once housed the pediatric department of Mannheim´s University Hospital. Today, the CRS clinic is capable of conducting large-scale trials such as QTc/cardiac safety (more than 200 subjects) and long-term trials (overnight stays up to 56 days). Whatever your trial aims at, CRS recruits suitable patients or healthy volunteers.
The CRS Mannheim unit also contains relevant laboratories (blood and urine processing, laminar flow hood), six examination rooms, and a central cardiovascular monitoring unit. And the hospital-like unit has its own minimal invasive operating theatre.
One of CSR Mannheim unit’s USPs is its proximity (500 meter distance) to a small-scale contract manufacturer for solids, semi-solids and sterile liquids, licensed according to § 13 AMG (Arzneimittelgesetz – German Medical Law). From EU drug import to packaging and labeling, over investigational medicinal product (IMP) reconstitutions under specific conditions – all can be provided according to the latest standards.
Additional CRS services, such as Clinical Data Management (CDM), Medical Writing, Quality Assurance, and Clinical Trial Supply Management (CTSM), are also located at our premises in Mannheim.
Moreover, CRS Mannheim offers – based on its particular drug development expertise – consultancy in drafting best development roadmaps and corresponding development budgeting.
Efficiently transforming challenging trial protocols into incontestable clinical evidence within a safe environment and in line with the applicable Good x Practice (GxP) standards – this is CRS Mannheim’s core competence. For this, the unit relies on its versatile and volunteer friendly setting.
The CRS Mannheim unit is situated in the center of Mannheim, three kilometers away from the main railway station and 500 meters from the Mannheim University Hospital. A tram stop in front of the CRS building makes CRS Mannheim easily accessible for healthy volunteers and patients.
Mannheim is located in the center of the Rhine-Neckar metropolitan area with a population of approximately 2.4 million people. With its surrounding major cities, such as Frankfurt, half hour north, Ludwigshafen and Heidelberg, both nearby, the Rhine-Neckar area is one of Germany’s driving economic centers, home to global companies. Also, this area is one of the most dynamic bio-pharmaceutical research hubs in Europe with famous companies and research institutes such as the German Cancer Research Centre (Deutsches Krebsforschungszentrum – DKFZ) and the renowned university hospitals of Heidelberg and Mannheim.
Thus, it is virtually inconceivable that there might be a restriction to the type of trial to be performed in the expert hands of CRS Mannheim. Clinical trials with particular challenges, such as, e.g., first-in-human (FiH) trials, trials on QTc, on lung function, and on narcotics/opioids, are regularly performed at highest quality standards.
The CRS team is familiar and at ease with performing trials on drug-drug and food-drug interaction, on bioequivalence (BE) and bioavailability (BA), especially with high numbers of 200 volunteers or more. In terms of patient access, the specialty of CRS Mannheim is clinical research on cardiometabolic diseases for which the unit relies upon a large and readily-available patient collective.
The Medical Director CRS Mannheim, Dr Dr Armin Schultz, has worked in clinical pharmacology for 25 years and is the author of several publications in this field. Sponsors from biotech to established pharma players, from global operating corporations to small and medium-sized enterprise (SME), they all benefit from his considerable expertise, which he gained in more than 500 executed trials, supported by a motivated and professional team of clinical experts in their fields.