Published on Wednesday December 28, 2016
Smooth Drug Development: 2016 summary
Smooth Drug Development would like to take the opportunity to wish you a Merry Christmas and a Happy New Year, as well as provide you with the summary of the 2016 results.
2016 was a year of influential events and intense changes – both in the pharmaceutical industry as well as in the world. New challenges, however, conduce further development and fresh ideas.
2016 has become a productive year for Smooth Drug Development. In 2016, we have broadened a spectrum of our services and identified new ways to improve clinical trials.
To enable comprehensive and consistent data within complex and long studies, this year we have started the of use e-diaries. The use of electronic diaries is supported by scientific research, which shows that memory recall of an event is often unreliable and laden with inaccuracies, further supporting the use of e-PRO versus traditional paper 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.
Drug registration and post-registration services
We have started to provide a wide spectrum of drug registration and post-registration services, which include:
- Risk management programs
- Patient registries
- Patient support programs
The highly awaited new document regulating the PVG principles in Russia and the Eurasian Economic Union (EEU) will be enforced soon. We were ready to adopt the new Pharmacovigilance (PVG) regulations in Russia and CIS. Our company is ready to provide a wide spectrum of services in accordance with the new requirements:
- 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
2016 in figures
# of eCRF fields programmed
60 000 fields
# of queries processed
26 286 queries
# of opened sites
# of enrolled patients
# of completed projects
130+ within 4 years
# of ongoing projects
# of critical audit findings
# of studies completed on time
# of employees
40% since 2015