Emphron Services for Investigator Initiated Trials
We have a full range of services to meet the complete data management and statistical needs of investigator initiated trials. These include:
- The Emphron “Trial Site” is a low cost and flexible
hosted clinical data base for investigator-initiated studies.
These study databases are cheaper to produce than the regulatory study databases, because of lower validation compliance overheads, but data are managed in the same enterprise class data centre facility as our regulatory studies.
- The Emphron “Trial Drive”
is a complete operating system and tailored study data base
delivered on a bootable USB thumb drive. Simply plug-in the thumb
drive, turn on the computer and a bespoke clinical data base system
loads automatically.
This solution is suitable for investigator initiated studies, and typically costs less than $1,000 (depending on study design). These simple solutions save hours of investigator time, and enhance data quality, without incurring the costs associated with full regulatory compliance. Each Trial Drive comes with a study database manual. Options exist for regular backup to a local hard drive, or by secure encrypted connection to our data centre. 24/7 phone support is available on a per incident basis, or pre-purchased.
- The Emphron “Trial Book”
is a dedicated laptop computer pre-loaded with a bespoke clinical
data base, suitable for investigator initiated studies.
These simple solutions save hours of investigator time, and enhance data quality, without incurring the costs associated with full regulatory compliance. Simply turn it on, and start work. Each Trial Book comes with a study data base manual. The solution typically costs $2,000 including the bespoke data base (depending on study design). If you return the Trial Book to Emphron at the end of the study, you receive a $750 credit for further services from Emphron.
Alternatively, Emphron will re-configure the Trial Book for your next study at a cost typically of $1,000. You can regularly back up trial data to the Emphron secure data centre , or to CD as the trial continues. The Emphron Trial Book is can be complertely independent of your existing IT infrastructure; in normal use you will have no need to connect to your institutional network. Should you need it, Emphron will supply wireless broadband internet connection on the Trial Book. 24/7 phone support is available on a per incident basis, or pre-purchased.
- Emphron Biostatistical Analysis of Investigator Initiated studies.
Analysis is tailored to meet the needs of the particular trial (which are often statistically more demanding than regulatory trials). A light quality process is used for statistical programming, but the statistical analysis is performed with rigour and attention to detail. When Emphron performs the analysis, we will support investigators in rebutting the frequently ill-informed comments and demands of journal reviewers. Costs depend on the number of data sets to be analysed, but are typically significantly lower than in-house solutions. Discounts are available when the data have been managed using Emphron services.