Investigator-initiated and grant-funded projects
Phase IV / Late Phase / Postmarketing surveillance projects
Most projects at the Phase IV level are investigator-initiated and grant-funded, and commonly have relatively limited budgets. We will work with your budget as a starting point, and build in as much functionality as possible within those constraints.
We have no set structure, software, or platform to conform to. The EDC platforms we create are custom built specifically to the criteria and protocols you set out for your study.
Once created, you own the application and the data - and unlike some other platforms your data is not mixed in with anyone else's. Once built, you are free to either run it on our servers for the life of the project, or move it to another server at any time.
We know clinical trials. We have been creating custom-built, late-phase EDC systems and other online data-gathering tools for over 25 years.
We take security very seriously, and adhere to medical-research levels of data and information security policies to keep your data secure. Further, we use only Canadian-based web and database servers (including backups) to host your web-based applications and are 100% FOIPOP/FIPPA compliant.
As a third party we can assure that each individual site, administrator, researcher and data-entry personal (the "users") have as little or as much access to the data as needed to satisfy A/B obfuscation and other ethics and review requirements.
We can provide assistance in the technical and/or security component of your grant or ethics application.
We can provide ongoing results, reports and analysis during the course of the study as needed. Data can be exported to Excel on demand, and analysis is commonly provided in either Excel, SPSS or Python (for higher-level analyses).
We like to maintain a close working relationship with the researcher in order to better understand the particular needs, constraints, potential concerns and idiosyncrasies of the study. Further we assume that you will need assistance in the way of updates and reporting throughout the life of the study, which may be 5 years or longer.