Judy Ingham

Agilis

We assist clinical trial teams to collect, manage and analyse their data. We develop our own cloud software systems, we have expertise in controlled clinical data management processes and deep know-how in statistical analysis. We have developed our own Cloud EDC/ePRO/eCOA software as a service, which we can quickly adapt to your needs, enrich with your requirements and which you have ready to use in the cloud. With real time monitoring tools to ensure data quality. Our EDC System includes specialised tools, such as for interactive randomisation, clinical image assessment adjudication, real-time visualisation of any variable, lab data. Tools that can be quickly implemented according to your needs and efficiently integrated in your system. We have a team of statistical consultants which can deliver complex statistical work at each stage of a trial, from inception, design and protocol to conclusive statistical analysis and reports for regulatory submission. From an ICH compliant SAP to clinical study reports, efficacy and safety reports ready for regulatory submission. We ensure your data are CDISC compliant, from CDASH and SDTM annotated CRFs to SDTM, ADAM and analysis scripts. Our team of clinical data management experts can assist you in your clinical data management tasks. You can trust their experience in robust processes and compliance, and let them become part of your team to ensure data quality and minimise data risks.