REGULATORY COMPLIANCE
We are aware that our work affects the demanding regulatory compliance of a clinical trial and we are committed to adhere strictly to all relevant compliance requirements, from FDA and EMA guidance for Good Clinical Practice (GCP) to EU-GDPR legislation for data protection. Our documented SOPs are designed with compliance requirements in mind and our team is trained to ensure compliance in all aspects of our work.
STANDARDS
Applying technical and organizational industry standards has always been one of our most fundamental work principles. We can provide clinical trial data following the CDISC family of standards, from CDASH for data collection to SDTM for tabulations and ADAM for analysis. We prepare our statistical reports from SAPs to CSRs following the ICH E3 guidelines and our clinical data management SOPs implement the SCDM guidelines. We are implementing an ISO/IEC 27001 system for information security.
QUALITY
Our SOPs are part of an integrated ISO9001 certified Quality Management System which has been specifically designed for the quality requirements of clinical research, covering Cloud Software Services and clinical data management work, statistical analysis and statistical programming and software development, with particular emphasis on risk management.
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Gregory Farmakis, Captain
Our business model is simple. You don't merely buy our cloud software or statistical services. You recruit a team of engineers and statisticians that become members of your own clinical trial team and share your commitment to the success of your trial.
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Maria Glossioti, Software Team Leader and IT Manager
A good software engineer is not somebody which is merely excellent in technology and software skills. A good software engineer has an in-depth understanding of the work the users are doing with our systems, their problems and their constraints. This is the culture of our team of software engineers.
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Anais Santourian, Statistics Team Leader
When our statisticians are doing analysis work and statistical programming, we are aware that our data concern real patients and have a deep feeling of responsibility. Statistics is a science and an art and can be very hard work. One cannot do it responsibly without commitment and passion.
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Sonia Chalkidou, Data Management Team Leader
Data management for clinical trials isn’t just about following SOPs, writing plans or validating data. It is primarily about working with CRO’s and sponsors to help them ensure the success of a trial at every simple single task, identifying risks early and solving problems. And this requires constant and close every-day communication with our clients.
