Phase IV (Late Phase) Clinical Trial EDC Systems
We design, create, and administer customized, online clinical trial and other online EDC systems for:
Why us?
Cost effective
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.
Custom-built
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.
YOU OWN IT (along with the data of course)
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.
Experienced
We know clinical trials. We have been creating custom-built, late-phase EDC systems and other online data-gathering tools for over 25 years.
SECURE (and FIPPA-Compliant)
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.
Third-Party, Arms-length Relationship (randomization / blind studies)
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.
Assistance with Grant & Ethics applications
We can provide assistance in the technical and/or security component of your grant or ethics application.
Assistance with Statistical analysis
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).
A close, ongoing relationship - We are in it for the long-haul
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.