Expertise
- The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3)1 modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration are mandatory at the same time. We can be contracted for those reporting activities.
- The EMA has prepared this eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to- face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The submission of data on medicines by marketing-authorisation holders is a legal requirement from Article 57(2) of Regulation (EC) No. 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012. We can be contracted for those submission activities.
- We have conducted a total of 9 clinical trials.
- High quality of projects conducted by us has been confirmed in more than 8 audits performed by Sponsors in the sites monitored by us, as well as during inspections with final reports showing no significant findings.
- We have a unique experience in conducting medical device trials.
- A phase III clinical trial in the end-stage renal disease (dialysis patients) conducted in 5 sites, including about 50 patients. The study was initially scheduled for 12 sites and 110 patients, however, due to recruitment problems in other regions, the recruitment commitment increased twofold owing to our engagement and determination, which eventually gave us 1/4 of region’s recruitment.
- Non – interventional project - a study of 15 sites and 120 patients.
- Two projects in haematology, phase III trials, reaching respectively 50% and 35% of the region’s recruitment.
- A study of phase II in oncology (breast cancer), in which we achieved 90% of planned recruitment.
- We planned and successfully conducted a non-interventional medical device study of 122 patients, providing full support to our partner; from the protocol design, throughout supervision and monitoring of the project to the final report, fully embracing very strict time lines.
