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 & INFORMATION SECURITY
Our SOPs are part of an integrated ISO 9001 / ISO 27001 certified Quality and Information Security Management System which have been designed with GCP compliance in mind, specifically for the quality and information security 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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Agilis
An agile company
About Agilis
Agilis has been founded in 1998 with a strong commitment in technology and statistics. Since then we have developed innovative technological solutions for data intensive applications and provided in-depth statistics consulting to international organisations. Our involvement with technology and statistics for clinical trials started more than ten years ago out of academic research projects and since then clinical trials have become our primary business and the focus of our technological and scientific strategy. We have provided high quality services in dozens of countries in four continents, we have actively participated in international standardisation initiatives and we know how to become team members in the teams of our customers, rather than mere vendors or suppliers.
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Software
A skillful team of software engineers
About Software
When using our clinical trial technology, you are actually recruiting an agile team of skillful software engineers, rather than just a license to use a software application. Of course our applications, which you can use as cloud software services, are robust, validated and proven in demanding clinical trials. But we are always ready to adapt them to your very specific needs, develop new features and functionality for you or even to work with you for a new software tool. In setting up your trials on our platform or implementing a complex custom functionality, you will work directly with our software engineers who will implement and test everything in close cooperation with you. We do not provide mere “user support”. We know how to become your co-workers and share your commitment to the success of your trial.
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Statistics
A team of expert statisticians
About Statistics
Our team of highly qualified expert statisticians can provide you the reassurance of statistical robustness and quality from the inception stage of a clinical trial to its final conclusions. From study design, sample estimation and randomisation, to the preparation of statistical analysis plans, to final statistical reports according to ICH standards. Our statistical programmers can create validated programs for analysis, preparation of statistical reports and compilation of your ready for regulatory submission CDISC data files. And we love non-typical tasks such as exploratory data analysis or intelligent algorithms to help you extract real valuable information from your clinical trial data.
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Data Management
A committed team for data management
About Data Management
Using our own applications, we can help you accomplish data management tasks of a clinical trial, according to Data Management Plans and Data Validation Plans we prepare. We can help you with ad hoc custom reports and data extraction from the trials database, calculation of monitoring and risk indicators, and help you monitor the progress of your trial and identify risks and problematic cases and issues as early as possible. Our data management team have years of hands-on experience in clinical trials and are the project managers of our clinical trial projects, being commited to ensure quality, timeliness and compliance. They work closely with our software engineers and statisticians to coordinate all our work for a clinical trial as an integrated project.
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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.
