SpiroLogistics
is a web-based platform for Clinical Trials developed by the company RDSM.
SpiroLogistics is FDA’s
21 CFR Subpart 11, CDISC
and HL7
compliant and thus satisfies the strictest requirements for Clinical Trials.
RDSM's cooperation with Clinical Research Organisations permits us to
do worldwide clinical trials.
At the moment the spirometers Spirobank, Spirolab
and Spirotel are already linked to the SpiroLogistics platform.
SpiroLogistics is directly linked to the software
of the medical devices in the doctor's office. The doctors work on their
PC with our Winspiro software, the standard software that is provided
with Spirobank and Spirotel. After the test, the doctor can send all
the test data that are important for the clinical trial, to the SpiroLogistics
server. These data are sent encrypted and anonymously via SOAP components
(XML).
Results are available in real time through a secure internet connection
(https). This means tremendous timesaving for the doctor and no more
possibility of making errors copying the results on a sheet of paper.
SpiroLogistics can easily be adapted to include other devices like ABPM,
ECG,
BPM,...
The advantages of using SpiroLogistics for Clinical Trials are:
- Cost and time saving for the trial leader: results do not need to be collected personally
- Time saving for the doctors: results do not need to be copied on sheets of paper
- Possibility of making written errors excluded
- Very strict security: data is sent encrypted and anonymously to the SpiroLogistics server
- Daily update of the clinical trial
- Daily overview on the cooperating centres' performances
- Integration of online questionnaires
- Wireless transmission from the patient's home to the server possible
- SpiroLogistics can easily be adapted to include other devices like blood pressure holter, electrocardiogram, blood pressure monitor,...
- FDA’s 21 CFR Subpart 11, CDISC and HL7 compliant
