In 1790, with a good horse, it took from four to six days, depending on the weather, to travel from Boston to New York. And nobody complained.
In 1890, it took the fastest steamship six days, four hours, and five minutes to cross the Ocean, so any mail (not e-mail but a piece of paper in an enveloppe) would take at least 10 days when sent from Europe to the US. And nobody complained.
In 2009, and using Fedex, it will take a Pharma company two days and $ 63.41 to send a Protocol update from their Boston office to a site in Amsterdam. And nobody complained. Continue reading
Clinical Trial Portals using Web 2.0 Technologies
CRF Design using Adobe Indesign
In a previous Blog-post, I have discussed the different requirements for (DataFax) CRF design for studies using paper forms compared to Electronic Data Capture (EDC). Especially when using DataFax as Clinical Data Management System (CDMS), it is equally possible to combine the two methods into one studie. Like a Patient Diary collected on paper forms, and the remainder by EDC. Or allow paper forms for sites which are lacking proper internet access. In these cases, you need to be able to be flexible in your CRF Design. Continue reading
Remote Virtual Desktop opens up new Possibilities
The new ‘Remote Virtual Desktop’ (RVD) service offered by Thorin to our Pharma clients, opens up a whole range of new opportunities. To trigger your mind, it is as if the user is actually working within a fully controlled environment, a kind of safe local network. Continue reading
DataFax eCRF Design
Perhaps not everybody realizes that using Electronic Data Capture (EDC) as method for data collection in a DataFax study, might impose some new Options and Requirements regarding CRF Design. Continue reading
Page Flow in a DataFax EDC study
The order of Forms in the Patient Binder in iDataFax does not always coincide with the actual order of Forms or CRF pages. While this might not be a big issue in a Paper based trial, it becomes more of an issue when your study is pure EDC based. Especially in an EDC study, you want to guide the Investigator as much as possible by taking him/her in the proper order along each relevant Form for a Visit. Continue reading
Edit Checks for EDC usage
Didn’t we say that you can use the same Edit Checks for both data collection from paper CRFs and for Electronic Data Collection (EDC) ? Eh yes, technically speaking, you can use the same Edit Checks. However, there are certain areas which require a different approach in Edit Check specifications. Continue reading
CRF Annotation: A boring Necessity or a part of the QA process ?
Most of the Annotated CRFs I have seen over the years were the product of a manual annotation process. As a result, they were mostly not error free and, probably due to the effort involved, were not always updated when the underlying database was. As part of these CRFs originated from non-DataFax studies, it is understandable why they were created using manual labor. Continue reading
Minimizing Number of Queries
There are numerous measures which can be taken to minimize the amount of Queries which needs to be sent to Sites (assuming that you are running a DataFax paper-based study). Things like a clear CRF design, proper Site training, early Feedback on any Data Management issues, etc. will all help to minimize the amount of Queries. Sometimes underestimated, but proper programming of your Edit Checks might also be very helpful in minimizing Queries. Continue reading
From DataFax to CDISC/SDTM
One of the more recent projects for a client was to export all data from DataFax into CDISC’s Standard Data Tabulation Model (“SDTM”). In this Blog, I want to share some of our experiences with this SDTM export. Continue reading
Quality is in the Person, not in the SOP
Having supported DataFax for over 15 years, it sometimes looks as if SOPs are used as an excuse NOT to focus on Quality. If I am convinced of one thing, it is that SOPs are not a guarantee for Quality. Continue reading