Smooth Drug Development offers a full range of clinical development services in Russia, CIS, Baltic States and Central and Eastern Europe.
It includes project management, planning, medical writing, obtaining of regulatory and ethics approvals, vendor management, logistics, clinical monitoring, pharmacovigilance, data management, quality assurance and control, biostatistics and preparation of the final study report. We offer both individual services and conduct of the entire study from start to finish.
All these activities are included in scope of our ISO 9001 certification and performed in strict accordance with the requirements of our quality management system, local and international regulations.
The main document for any set of our services is a Contract between Smooth and the Customer. It includes the distribution of responsibilities between our company and the Sponsor, the budget and project schedule. We respect the time and money of our Clients, so at planning and conduct of trials we adhere to the principle of changeless budget and milestones, unless requested by the Customer. Most of our contracts are fixed-price with milestone payments. That is why we have an obvious interest to achieve milestones in time, and when it is possible – ahead of schedule.
We are well aware that the timing of study determine the terms of further product registration, which connected to the production schedule and launch, marketing activities and fulfillment of the budgetary policy of our Clients. When we plan a project, we try to use all our experience to determine the realistic time and cost of the study, in order to avoid unfavorable changes in the future.
Any study is a complex organizational process that involves many parties and, therefore, implies organizational risks. In cases when our company is responsible for all or most aspects of the study, we take most risks, with the exception of force majeure. This means that in case of such risks, our company will take necessary corrective measures, and the time and cost of the study for the Client will remain unchanged.
Our professionals have experience in different types of clinical trials in different nosologies. Study team is always built based on the experience of our employees for a particular study. If necessary, we are able to attract additional qualified personnel to conduct larger trials.
We provide the following services in clinical trials:
- Project management
- Medical writing
- Feasibility and site selection
- Regulatory support
- Data management
- Logistics and storage
- Clinical monitoring
- Investigator support
- Medical monitoring
- Bioanalytical laboratory
- Central laboratory
- Biomedical statistics
- Clinical study report
- GCP audit
Smooth Drug Development, a leading CRO in Russia, CIS and Central Eastern Europe, provides a full range of services for clinical trials since 2011.