pl | en search About company Registration of medicinal products Product development Clinical tests job Experience contact Pre-registration service Conducting the registration process Post -registration services Registration of medicinal products Assessment of registration dossier. Assessment of manufacturing sites and manufacturers' documentation Product development Organizing and monitoring clinical trials. Certification and batch release Clinical tests The company is entered in the register of entrepreneurs kept by the District Court for the capital city of Warsaw in Warsaw, XIII Commercial Division of the National Court Register under the number: 0000514366, NIP: 1132716724, REGON: 141381910. Copyright © Health-Med. Design and execution: Bull Design

pl | en search About company Registration of medicinal products Product development Clinical tests job Experience contact Clinical trials Organizing and monitoring clinical trials. Certification and batch release Clinical trials Organizing and monitoring clinical trials Home / Clinical trials / Organizing and monitoring clinical trials We offer comprehensive services including preparation for clinical trials, including preparation of a detailed schedule of the trial, monitoring of clinical trials, and verification of the analytical and statistical part of the trial. We take care to comply with high-quality services in accordance with the applicable GCP and GLP standards. We offer: comprehensive analysis of the study design, including: determination of the number of patients necessary to obtain the appropriate test power, selection of endpoints, hypothesis assumptions, statistical plan; preparation of documentation: Study Protocol, Investigator's Brochure, Information for the volunteer, Informed consent form and CRF (Case Report Form); preparation or completion of study documentation to be submitted to the Central Register of Clinical Trials (CEBK) in order to obtain consent to commence a clinical trial and to the Bioethics Committee (KB) in order to obtain a positive opinion on the study; monitoring of clinical trials according to the latest standards and guidelines; conducting audits of centers in terms of compliance with all requirements: applicable law, GCP principles, standard operating procedures; preparation of the Final Report on the study in a format compliant with the requirements of ICH E3. back to top | print version Pre-registration service Conducting the registration process Post -registration services Registration of medicinal products Assessment of registration dossier. Assessment of manufacturing sites and manufacturers' documentation Product development Organizing and monitoring clinical trials. Certification and batch release Clinical tests The company is entered in the register of entrepreneurs kept by the District Court for the capital city of Warsaw in Warsaw, XIII Commercial Division of the National Court Register under the number: 0000514366, NIP: 1132716724, REGON: 141381910. Copyright © Health-Med. Design and execution: Bull Design