CRS Kiel is conducting clinical trials across all trial designs dedicated to human pharmacological and clinical research. A focus here is on small to mid-sized clinical trials and challenging pharmacokinetic (PK) and pharmacodynamic (PD) assessments with renally and hepatically impaired patients in mild to severe disease stages and with elderly patients.
Since the early 1990s, CRS Kiel has hosted clinical trials for patients with renal and hepatic impairment under the supervision of Dr Atef Halabi, Managing & Medical Director. Thus, the CRS Kiel staff is highly experienced and familiar with this particular patient population and is continuously trained in this. It also has gained extensive knowledge regarding the potential risks that may occur for trial participants. An internist, an anaesthesiologist, and a dermatologist, all well experienced, are also available on-site.
All this facilitates complete diagnostics, recruitment, medical care, treatment with trial medication, and co-medication of particular vulnerable patients. Overall, the unit is one of the top recruiters worldwide for patients suffering from hepatic and renal insufficiency. More than 90 percent of CRS Kiel clinical trials dealt with such vulnerable patients. However, the staff is also familiar with healthy test subjects.
The CRS Kiel unit is equipped with all necessary devices and – of course – with a sophisticated telemetric system, which enables the continuous monitoring of all trial participants and the observation of the entire clinic.
In most trials only one or two trial participants are hospitalized in one room. Two separate rooms are reserved for medical examinations. And a CRS own in-house pharmacy, supervised by a pharmacist, allows the regular storage and dispensation of trial medication.
Furthermore, CRS Kiel maintains a longstanding and successful cooperation with a local medical lab as a preferred partner, specialized for the support of clinical trials. Its analytical quality is regularly certified and it is accredited by the German health authorities.
This local cooperation secures a reliable and rapid turnaround of laboratory results, most of which will be supplied within six hours, facilitating screening and review of inclusion/exclusion criteria, as well as close safety monitoring of trial participants.
Besides, an in-house medical lab for blood and urine processing is also a proprietary part of CRS Kiel. Beyond that, the unit is just as experienced with other central labs located worldwide.
The CRS Kiel unit for early phase clinical research is directly adjacent to the Kiel University Hospital. The unit resides in a mid-sized town house (300 square meters); its design and spacial arrangement provide a welcoming environment and create a good atmosphere for all clinical trial participants, mainly in-patients and members of vulnerable patient populations.
Kiel is located in northern Germany on the coast of the Baltic Sea, about 100 kilometers north of the Free and Hanseatic City of Hamburg. With approximately 250,000 inhabitants, Kiel is one of the 30 biggest cities in Germany and the capital of the German Federal State of Schleswig-Holstein.