As early as 2010, the EU Regulation No. 1235/2010 kicked off a reorientation in drug safety. The aim was and is to create more transparency with standardized approval procedures and to provide faster and better information about drug safety. This November, the transitional period for the new version of the pan-European database ends. From November 22, 2017, all individual safety reports must be stored electronically in the EudraVigilance database. For this purpose, the EMA provides the reporting tool “EVWEB”, which may only be used by specially trained and accredited specialist staff. Entries are made in the new E2B (R3) format.
Concentrated Knowhow for Pharmacovigilance
SSS International Clinical Research reacts to this new regulation and strengthens its competence in the pharmacovigilance area. For ten years, an experienced team of pharmacologists, biologists and physicians have been established at the Romanian site in Timisoara. In addition to local clinical trials for clients in the pharmaceutical and biotechnology industries, drug safety responsibilities have been pooled for years at this site. The new European standards required additional measures to qualify and accredit the technical staff. “During the last months, we completed the comprehensive training curriculum recommended by the EMA and are now in the best possible position. In addition, we have accredited our EMA staff to EudraVigilance, so we can continue to provide our clients with expert and comprehensive support in the area of drug safety.” reports Dr. Dan Sabou, Managing Director Romania, SSS International Clinical Research.
Other regulations of clinical research are also under continuous development. Dr. Michael Sigmund, owner and Managing Director of the German parent company of SSS, has been observing the changes in the regulatory environment for years: “In order to keep up with the demands, a constant and up-to-date training of our employees is of the utmost importance. Developing and bundling competencies is essential to us in order to provide our customers with reliable, complete and compliant services. Our specialized team in Romania has a key role to play for the pharmacovigilance services we offer.”
Founded in 1993 and with about 50 employees today, SSS works with biotech, medtech, diagnostics and pharmaceutical companies throughout Europe as a clinical contract research institute (CRO). In 2009, the 1997 DIN EN ISO certification has been expanded to DIN ISO EN 9001. This ensures smooth, efficient and rule-consistent conduct of the contracted clinical studies. SSS provides a full spectrum service from medical and statistical planning, study submission and approval process at Regulatory Authorities and Ethic Committees, performance of full monitoring service up to the biometric assessment and the study report generation.
The special flexibility of the innovative and IT-process-driven company continues to convince corporations as well as medium-sized enterprises. The company headquarters is located in Germering near Munich with further locations in Poland and Romania. SSS is a member of the Federal Association of Contract Research Organizations (BVMA) and the business association of the German Biotechnology Industry, BIO Deutschland.
SSS International Clinical Research GmbH
Landsberger Straße 23/25
82110 Germering
Telefon: +49 (89) 8006500
Telefax: +49 (89) 800650555
http://www.cro-sss.de
Telefon: +49 (89) 800650-0
E-Mail: presse@cro-sss.com