CRS Berlin is housed in the top floor of an appealing building located in the heart of Berlin. Owing to the complex floor plan and an intelligent access control system in-house and outpatient clinical trial activities can be spatially separated, allowing the simultaneous conduct of several studies without interference.

CRS Berlin and its Outstanding Expertise

A major scope of the CRS Berlin unit is the conduct of early phase clinical trials in the area of women’s health, including postmenopausal women. This especially covers first-in-human (FiH) and long-term outpatient studies with challenging pharmacokinetic (PK) / pharmacodynamic (PD) designs including a broad spectrum of medicine administration routes (oral, dermal, subcutaneous, intravenous, intravaginal, intrauterine). It also covers early phase clinical trials with special populations such as women with endometriosis or polycystic ovary syndrome (PCOS). A plurality of established as well as experimental gynecological methods are applied by board certified gynecologist at our site, e.g., standard gynecological examinations, transvaginal ultrasound, vaginal cytology, endometrial biopsy, Insler and Hoogland scores – these are just some examples illustrating the techniques in command of CRS Berlin.

Outpatient studies with women of childbearing potential can be conducted either cycle-dependent or with a synchronizing cycle intervention preceding the treatment phase, which is leading to more grouped treatment schedules.

Infrastructure & Location

CRS-Berlin is housed in the top floor of an appealing building on the brink of the Bayer site in Berlin. A separate entrance, an automatic access control system and an independent technical infrastructure guarantees for a strict segregation from the circumjacent Bayer facilities.

Network of Expertise

• Healthy Volunteers
• Women‘s Health
• Men‘s Health
• Early Research Unit in Berlin

Owing to the specialised layout of CRS-Berlin, in-house and outpatient clinical trial activities can be spatially separated allowing several studies to be run simultaneously without cross-interference. This CPU contains 20 intensive care beds, each equipped with an ECG, SpO2 and vital signs monitoring system, a computerised ECG device, as well as 8 convenient double rooms (i.e. 16 beds). CRS-Berlin also comprises several examination rooms, a gynaecological unit with two examination chairs, state-of-the-art ultrasound equipment and various laboratories for immediate blood and urine processing. On-site gynaecological examinations, including Isler- and Hoogland scoring, endometrial biopsies and transvaginal ultrasounds (TVUS), are just a few selected examples illustrating the benefits of working with CRS-Berlin.

Dr Sybille Baumann, a board member certified in clinical pharmacology and anaesthesiology, is the medical director of CRS-Berlin. Dr. Baumann is an experienced Clinician and Clinical Pharmacologist with more than 25 years’ extensive experience in over 350 clinical drug studies as co- and principal investigator. A highly dedicated team of 30 qualified clinic employees and 15 Freelancers contributes to the successful conduct of trials.

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