Our history
Company name Smooth Drug Development reflects our main principle – to provide a constant and continuous development of pharmaceutical products for our Clients*.
Key milestones:
2004
The company originates from a multidisciplinary investigational site based on clinics of St. Petersburg State Pediatric Medical Academy.
The company originates from a multidisciplinary investigational site based on clinics of St. Petersburg State Pediatric Medical Academy.
2007
A new investigational site is organized at St. Petersburg City Mariinsky hospital.
A new investigational site is organized at St. Petersburg City Mariinsky hospital.
2008
Several investigational sites are joined to a Site Management Organization named SMOoth Clinical Trials.
Several investigational sites are joined to a Site Management Organization named SMOoth Clinical Trials.
2010
The first Phase I and bioequivalence unit opened at St. City Mariinsky hospital.
The first Phase I and bioequivalence unit opened at St. City Mariinsky hospital.
2011
The company expands its services and starts working as a Contract Research Organization in bioequivalence and non-inferiority trials with generic products.
The company expands its services and starts working as a Contract Research Organization in bioequivalence and non-inferiority trials with generic products.
2012
The second Phase I and bioequivalence unit opened at St. Petersburg City Hospital №26.
The second Phase I and bioequivalence unit opened at St. Petersburg City Hospital №26.
2013
The company expands to a full-service Contract Research Organization under the new brand of Smooth Drug Development.
The company expands to a full-service Contract Research Organization under the new brand of Smooth Drug Development.
2014
The first specialized pharmacological center in Russia BioEq® is opened, which acquires businesses of Phase I and bioequivalence units at the Mariinsky Hospital and City Hospital №26. Smooth Drug Development and BioEq® become independent partners.
The first specialized pharmacological center in Russia BioEq® is opened, which acquires businesses of Phase I and bioequivalence units at the Mariinsky Hospital and City Hospital №26. Smooth Drug Development and BioEq® become independent partners.
2016
Smooth Drug Development expands into Estonia, Latvia, Lithuania, and Germany and adds new post-registration services:
Smooth Drug Development expands into Estonia, Latvia, Lithuania, and Germany and adds new post-registration services:
- Risk management programs
- Patient registries
- Patient support programs
- Pharmacovigilance:
- PVG Qualified Person
- Adverse event management
- Safety database services
- Global and local literature database search strategy and review
- Individual case reporting
- Aggregate report management
- Signal management
What is more, to enable comprehensive and consistent data within complex and long studies, in 2016 we started the of use e-diaries. Smooth team have designed electronic diaries to engage patients to submit time-sensitive health information while they go about their daily routines. Smooth uses specially designed Tablet or Mobile phone devices for instant data capture and transfer to a centralized data center.
2018
Smooth Drug Development expands into Hungary, Serbia, Slovakia and Croatia.
Smooth Drug Development expands into Hungary, Serbia, Slovakia and Croatia.
2019
The company becomes one of the centers of collective use of Skolkovo.
The company becomes one of the centers of collective use of Skolkovo.
Currently, the company provides a full range of CRO services for the pharmaceutical and biotech industry in the following areas:
- Consulting center
- Pre-clinical research
- Clinical trials
- Drug registration
- Pharmacovigilance
- Post-marketing surveillance
- Training center
*Smooth – even and uninterrupted in flow or flight (Merriam-Webster Dictionary).