Computerised pharmacodynamic assessments are done using Kendle Early Stage's proprietary Scheduled Measurement System (DL-SMS) that manages the scheduling, presentation and collection of data from pharmacodynamic measures. DL-SMS has been fully validated and meets the industry standards for computerized testing (FDA’s Title 21 Code of Federal Regulations Part 11).
DL-SMS is ideal for early phase studies due to its unique front-end system, which allows for multiple and frequent assessments of pharmacodynamic variables.
DL-SMS measures include a variety of industry recognized questionnaires and rating scales, objective neurocognitive performance tests, as well as various commercially available software and devices.
The following DL-SMS products versions are available:
DL-SMS Cog – especially suitable for the assessments of neurocognitive impairment or enhancement due to drug effects alone
DL-SMS Abuse – for the assessment of abuse liability
DL-SMS Interaction – for assessment of drug/drug interactions
DL-SMS Alcohol – for the assessment of drug/alcohol interactions
Easy setup: DL-SMS is configured and custom-tailored for each individual study. Extensive user-acceptance testing is performed prior to the start of a study to ensure accuracy and reliability of the system.
Scheduling: For each subject in a study, DL-SMS keeps track of the completed and displays the upcoming testing schedule alerting our clinical staff of the next test cycle. Once a staff member has authorised the subject's testing cycle by way of a secure password, the measures follow one after the other without further intervention.
Reporting: Along with an electronic data record, DL-SMS produces hardcopy summary tabular and graphic reports of each day's data collection. Data can be exported in a format that can be easily read by a variety of statistical analysis tools. Thus, the results of DL-SMS measures can be imported directly into the study's database without transcribing or keying traditional paper case record forms.
Kendle Early Stage's proprietary DL-SMS software can enable pharmacodynamic measurement across a wide range of specialized CNS studies.
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