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 adds new post-registration services:
Smooth Drug Development 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.
Today
Currently, the company provides a full range of CRO services for the pharmaceutical and biotech industry in the following areas:
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
Currently, the company performs local, regional and international studies in Russia, CIS and Baltic States.
*Smooth – even and uninterrupted in flow or flight (Merriam-Webster Dictionary).