Evado eSource replaces the paper based CRF booklet with a number of intuitive electronic records.
Evado eSource has been designed for Phase 1, 2, and 4. Including: post-marketing safety surveillance (PMSS) studies and post authorization safety study (PASS).
Evado’s clients include:
- Big Pharma
- Medical device companies
- Nutraceutical and complementary medicine companies
- Run an unlimited number of trials and studies simultaneously in the one environment.
- Computes the total number of data points in the trial.
- Generates the CRF booklet at the completion of the trial or study.
- Forms can be created, edited, revised and issued on line.
- Online schedule and form design
- Quick and easy to learn.
- Simplifies trial record management.
- Easy creation and completion of form records.
- Form layouts can be reused across multiple clinical projects.
- Provides on line access to completed trial records with a standard browser.
Evado eSource replaces the paper based CRF one or more intuitive electronic form records and then:
- Investigators fill in a forms for each subject consultation.
- Completed forms are submitted as project records.
- Investigators can review and update records.
- Evado has a record monitoring and data management query resolution process.
- Records can be tagged as source data verified by monitors.
- Data managers can review and lock completed records.
- Records can be combined to generate the CRF booklet that can either be printed or stored electronically.
- Electronic source data collection.
Medical device specific features:
- Implant date visit scheduling.
- Followup questionnaires.
- Support for industry standard questionnaires.
Clinical Research management teams can:
- view subject records at any point in the trial.
- monitor the progress of the trial.
- Sponsors can be given read only and real time access to the trial data to view the trial’s progress.
Other Features include:
- Collection of ancillary records and files.
- Collection of concomitant medications, adverse events and serious adverse events.
- Alert and notifications when queries or adverse events are raised.
- Preliminary online analysis of trial or registry data.
- Data export for statistical analysis.
The questionnaire module can be used to anonymously to collect patient followup questionnaires:
- Sites select one or more patients to receive the questionnaire.
- Questionnaires are sent out using a registered patient email address that is privacy managed.
- The patient can open and complete the questionnaire online.
- The completed questionnaire is added to the patient’s trial or registry data collection without disclosing the patient’s identity.
Scanned questionnaire module
Scanned questionnaire module is used to scan paper based questionnaires into Evado eClinical (scheduled for release in late 2018):
- Site initialise the creation of the patient’s questionnaire form.
- The patient completes the questionnaire
- The completed questionnaire is collected and scanned then uploaded to Evado eClinical where is added to the patient’s trial or registry data collection.
The Evado data collection approach is based on trial sites completing one or more records during each visit, where each record represents a CRF. When completed, trial data can be viewed on line, or printed to PDF or hard copy.
By knowing the number of visits in the trial, the number of record that were to be completed in any visit, and the number of fields in each record form, Evado can compute the total number of data point in the trial. Evado uses this computation to generate the output files for statistical analysis. Trial data is exported as CSV files that can be imported into statistical packages such as SAS or SPSS.