Smooth Drug Development in United States

E-mail:info@smoothdd.com

Web:https://smoothdd.com/

Phone:+13026600614

Address:

  • 2711 Centerville Road, Suite 400 Wilmington, DE, USA, 19808

Other Smooth Drug Development's locations around the world

About Smooth Drug Development

Smooth Drug Development offers a full range of clinical development services in Europe and Asia (Baltic States, Belarus, Bulgaria, Hungary, Germany, Moldova, Russia, Serbia, Spain, Slovakia, India, Kazakhstan, Uzbekistan). 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 stand alone services and conduct of the entire study from start to finish. All these activities are included in scope of our ISO 9001, ISO 27001, ISO 22301 certifications and performed in strict accordance with the requirements of our quality management system, local and international regulations. 

Smooth Drug Development uses the most advanced electronic solutions in clinical trials which help to perform studies quicker and with smaller resources. We use a self-developed Clinical Trials Management System (CTMS), which is an essential set of tools to effectively plan, manage and track clinical trials: eDC / eSource / IWRS eTMF / eISF ePRO Learning / QMS Personal Folder Clinical Monitoring Smooth CTMS is validated and is compliant with FDA CFR 21 Part 11 requirements. The system is also compliant with relevant standards, which are essential when it comes to striving for good practices (GxP).

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