Smooth Drug Development offers a full range of clinical trial, drug registration and post-marketing services, including consulting, development of registration strategy, conduct of clinical studies and pharmacovigilance in Europe and Asia. We cover wide geography: -Russia -Ukraine -Belarus -Kazakhstan -Latvia -Lithuania -Estonia -Serbia -Slovakia -Hungary -Germany -Spain Our company implemented the principle of "one stop service" when all activities from planning to product registration are performed consistently under the control of a team of professionals. According to the requirements of ISO 9001:2015, in case of outsourcing of vendors we manage their activities as our ones and are fully responsible for the results. Our Clients are leading pharmaceutical, biotech and R&D companies located in Europe, US, CIS and Asia-Pacific region. We offer drug development services: -Consulting center -Pre-clinical research -Clinical trials -ePRO -eTMF/eISF -Drug registration -Post-marketing surveillance -Pharmacovigilance -Training center We are experts in clinical services: -Project management -Medical writing -Feasibility and site selection -Regulatory support -Data management -Logistics and storage -Clinical monitoring -Medical monitoring -Pharmacovigilance -Bioanalytical and central laboratories -Biomedical statistics -Clinical study report -GCP audit Smooth Drug Development has unique IT solutions for clinical trials which help to speed up clinical trials processes and daily activities. Smooth CTMS includes the following modules: -EDC/eSource/IWRS -eTMF/eISF -ePRO -Learning / QMS -Personal Folder -Clinical Monitoring Smooth Drug Development has been ISO certified: -ISO 9001:2015 Quality Management Systems -ISO 27001:2013 Information Security Management Systems -ISO 22301:2019 Business Continuity Management Systems Please contact us at bd@smoothdd.com to learn more about Smooth Drug Development capabilities.
