Smooth Drug Development summarizes results of 2017

Smooth Drug Development would like to wish you a Merry Christmas and a Happy New Year and present the annual summary of our achievements for 2017.

2017 was a remarkable year, which has brought many opportunities, changes, and challenges. Smooth Drug Development put all circumstances to good use, and enhanced its position in the clinical research market in Russia and the CIS.

In 2017, we strengthened Smooth Drug Development presence in the CIS and the European market, and enhanced its quality management systems. Company specialists participated in over 10 international conferences and took part in educational seminars organized by regulatory bodies, in several specialized industry events our specialists presented as speakers.

Smooth Drug Development is an ISO 9001 and 22301 certified company, which provides a full range of clinical services for the pharmaceutical and biotechnology industry including management of phase I-IV clinical trials and bioequivalence studies as well as post-registration activities in Russia, the CIS, the Baltic States and Germany.

In 2017, we increased our staff, extended office spaces, and enhanced international presence. In the past year, our company held up to 40 projects simultaneously, which facilitated significant growth of our operational departments. Our St. Petersburg office has extended, and now occupies the two upper floors of the “Ligov” business center, while our Moscow office has moved to the highest acting European skyscraper, the Federation Tower of Moscow City. We also significantly extended operations in Germany and hired personnel in the USA.

In 2017, we renewed our ISO 9001:2015 certificate in Quality Management System. Also, we obtained ISO 22301:2012 certificate in Business Continuity Management System. Compliance has been audited and confirmed by the European inspection and certification company EUROCERT S.A.

Business Continuity Management certification is another proof of Smooth Drug Development leadership in providing quality and reliable clinical trials services. It demonstrates company's ability to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from any type of disruptive incident for our business and during a clinical trial.

Smooth is about to be certified according to ISO 27001:2013 Information security management systems in 2018. We care about quality and security of our services and do our best to get international recognition of our achievements.

In the course of 2017, we have been advancing our ePRO solutions. We successfully set up the operation of electronic diaries, and published an article on the efficacy of Smooth ePRO utilization in clinical research. If you are interested in learning unequivocal advantages of Smooth ePRO, please, follow this link.

Drug Registration and Post-Registration Services

In 2017, the authorities of the countries of the Eurasian Economic Union (EEU) enforced new PVG (Pharmacovigilance) regulations, which effected drug regulation in Russia and the CIS. Our company formed a PVG unit within our Scientific department, which is trained to provide a wide spectrum of services in accordance with the new requirements. Smooth PVG unit effectively supports projects of our international partners in Russia and has already demonstrated good results during several audits of big international companies.

# of prepared documents packages: 40
# of CTDs:12
# of opened sites: 500+
# of enrolled patients: 8000+
# of completed projects: 30+
# of signed clinical trial contracts: 46
# of critical audit findings: 0
# of studies on time or before schedule: 100 %
# of ongoing projects: 50+
# of new staff members: 45+
# of international events: 10
Revenue growth: 40 %