ClinStat GmbH
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Cologne, DE
ClinStat is an independent contract research organization (CRO) located in Cologne as headquarter and Berlin, Germany. Since our foundation ten years ago, we act as a supporting partner for pharmaceutical companies, hospital facilities, manufacturers of medicinal products as well as health insurance providers and other medically-oriented institutions.
We offer services for pre-clinical studies, clinical studies of phases I-IV, post-marketing studies and observational studies in pharmaceutical research. Additionally, we act as an experienced partner for epidemiological studies, studies in health services research/public health as well as studies concerning health economics. For some pharmaceutical companies, we have a special position as preferred CRO.
The cornerstone of success at ClinStat is our highly qualified team, which has a broad scientific background and profound knowledge in clinical research. We work according to the current international quality standards and guidelines and have the competence and capability to integrate the client-specific needs.
Selected Publications
Beyer-Westendorf J., Ebertz F., Förster K., Gelbricht V., Michalski F., Köhler C., Werth S., Endiq H., Pannach S., Tittl L., Sahin K., Daschkow K., Weiss N. Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2015, 113(6), 1247-1257
Beyer-Westendorf J., Förster K., Ebertz F., Gelbricht V., Schreier T., Göbelt M., Michalski F., Endiq H., Sahin K., Tittl L., Weiss N. Drug persistence with rivaroxaban therapy in atrial fibrillation patients - results from the Dresden non-interventional oral anticoagulation registry. Europace 2015, 17(4), 530-538
Domröse, C.M., Keyver-Paik, M.-D., Lorenzen, H., Kuhn, W.C., Mallmann, M.R., 2016. Development of obstetrical and gynecological journals, 2007 to 2013: a trend analysis. Arch Gynecol Obstet 293, 383–389. doi:10.1007/s00404-015-3818-7
Hecker J., Marten S., Keller L., Helmert S., Michalski F., Werth S., Sahin K., Tittl L., Beyer-Westendorf J. Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2016, 115(5), 939-949.
Hohnloser SH., Cappato R., Ezekowitz MD., Evers T., Sahin K., Meng IL., van Eickels M., Camm AJ. Patient-reported treatment satisfaction and budged impact with rivaroxaban vs. standard therapy in elective cardioversion of atrial fibrillation: a post hoc analysis of the X-VeRT trial. Europace 2016, 18(2), 184-190.
Kooistra HA., Gebel M., Sahin K., Lensing WL., Meijer K.
Independent predictors of poor vitamin K antagonist control in venous thromboembolism patients: data from the Einstein-DVT and PE studies. Thromb Haemost 2015, 114(6), 1136-1143.
Michalski F., Tittl L., Werth S., Hänsel U., Pannach S., Sahin K., Weiss N. Beyer-Westendorf J. Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants. Results from the Dresden NOAC registry. Thromb Haemost 2015, 114(5), 1076-1084.
Pintea, B., Kandenwein, J.A., Lorenzen, H., Blume, C., Daher, F., Kristof, R.A., 2016. Differences in clinical presentation, intraoperative findings and outcome between petroclival and lateral posterior pyramid meningioma. Clinical Neurology and Neurosurgery 141, 122–128. doi:10.1016/j.clineuro.2016.01.012
Sauerbruch, T., Mengel, M., Dollinger, M., Zipprich, A., Rössle, M., Panther, E., Wiest, R., Caca, K., Hoffmeister, A., Lutz, H., Schoo, R., Lorenzen, H., Trebicka, J., Appenrodt, B., Schepke, M., Fimmers, R., 2015. Prevention of Rebleeding From Esophageal Varices in Patients With Cirrhosis Receiving Small-Diameter Stents Versus Hemodynamically Controlled Medical Therapy. Gastroenterology 149, 660–668.e1. doi:10.1053/j.gastro.2015.05.011
Clinstat's experienced professional programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays. The statistical programming team is committed to deliver customized, fully validated deliverables. Our Statistical Programmers bring high-level education, good experience, and technical knowledge. With high-level professionals leading our programming team and expertise throughout the department, our programming staff is equipped to completely support the requirements of any project.
Our clinical statistics programming team members participate in annual programming conferences and workshops. The team members attend also external SAS training courses and conferences.
For any phase of drug development, our statistical programmer offer comprehensive services
including:
Health economics addresses issues related to limitations in the allocation of health and healthcare resources. Limitations implies, that payers had to make choices among multiple, different interventions to get the best way of available funding. In this context demonstrating value for money is different. Does your drug or device improve clinical outcomes enough to justify the funds spent, compared with alternative uses of the same money?
ClinStats health economics and outcomes research services help you to perform:
ClinStat offers the complete range of statistical services. Our industry-experienced biostatisticians in collaboration with our clinical SAS programmers deliver high-quality products. Biostatistician at ClinStat with their expertise in special indications and profound understanding of ICH-GCP guidelines and regulatory requirements insure best quality work over all stages of clinical development.
Our services include:
Statistical software
As a client-oriented institute for clinical research and statistics, ClinStat offers our clients tailored solutions in nearly all important therapeutic areas. Our highly qualified data managers adhere strictly to international and national quality standards from the beginning of the project until the end.
Superb data management is an important factor in clinical research. With the planning, creation, validation and documentation of the study database, we ensure that complete, correct and reliable electronic data collection is possible. To ensure integrity and validity, we implement quality assurance and quality control measures.
Our services cover:
Medical writing and the preparation of research-relevant documents must meet regulatory and clinical requirements. We ensure this through diligent planning of studies, accurate reporting, a well-documented approval process as well as constant monitoring and review.
All facts must be depicted and presented in a precise, clear and comprehensive manner. With our know-how and comprehensive resources, our team will prepare all study-specific documents and presentations for you. You can either take advantage of individual services included in our range of services or our complete medical writing service. We will work closely with you, taking company and study-specific needs into account, and we will always keep you up-to-date.
We support you with the preparation of:
Regulatory Affairs Services
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