Smooth Drug Development, next generation e-CRO in Europe and Asia

Biotechnology ResearchDelaware, United States51-200 Employees

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:
-EAEA Region
-Europe
-Latvia
-Lithuania
-Estonia
-Serbia
-Slovakia
-Hungary
-Germany
-Spain
-Turkiye 
-India
-Pakistan
-China

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 or cd@smoothdd.com to learn more about Smooth Drug Development capabilities.

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