Clinical Trial Data Mangement
If you are looking for a low cost, validated electronic data managment system designed by FDA reviewers, we may have what you need. This sytem can be used for paper-based studies, electronic-based studies, or a hybrid of the two.
EDC
Our data management system is based on Microsoft Infopath, a component of Microsoft Office Enterprise Edition. The Infopath Case Report Forms can be designed very quickly, and include numeric/text/date entry fields, error checking and validation, and electronic signatures. The CRFs can be filled out either online or offline, and submitted to the clinical database (we use SQL Server for the database).
Since the CRFs include immediate error flagging, the data quality is much improved. We also run additional scripts to QC the data and auto generate queries.
What We Deliver
For each clinical trial, we provide:
- all of the completed CRFs in both PDF and XML formats.
- the cleaned clinical database.
- the query log with all queries and their resolution.
- patient profiles for each patient
Pricing
It is always frustrating when you can't find out online how much clinical data management services cost. Thus, while each trial is unique, we can provide some estimates.
For a typical paper-based phase II or III trial, our data managment service costs on average $2,000 per patient. This includes:
- build clinical database
- build Infopath data entry forms
- double data entry
- data QC and queries
For a typical EDC-based phase II or III trial, our data managment service costs on average $90,000 per study. This includes:
- build clinical database
- build Infopath data entry forms
- host electronic CRFs on trial website (dedicated server)
- site training
- online study status reports (at the patient/ level, center level, and study level)
- data QC and queries
