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eBio Equivalence is a comprehensive and versatile application software tailored to effectively manage the entire bioequivalence study process. |
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The key processes - Volunteer Data Base management, Volunteer
enrolment and eData Capture are perfectly encapsulated in our eBio-equivalence Software. The application completely automates the procedure.
It speeds up the process given the time critical path for their execution, ensures that they are error proof and pro actively guides the
sequence. |
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Some of the salient features are: |
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Volunteer Registration |
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An active subject database maintains critical subject data with personal information, demographics, proof of
identity, medical examination records and enrolment history. All very crucial to the success of subject management
for studies. |
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Study Enrolment |
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Enrolment of Subjects for specific studies is supported through application of inclusion/exclusion criterion as the
subjects are selected for a particular study. Application enforces the statutory norms where required. |
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Authentication |
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Authentication is crucial. Bio Metric and Bar Coding technology authenticates subjects. Finger print matching and identity
cards with Bar codes and photographs are used at every interface, touch point. |
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Sample Tracking |
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Bar code technology is used for Sample tracking. Each sample drawn is clearly tagged with sample
information in terms of: study identification, subject-id, sequence and time. The link is carried through Centrifuge, Seperation and Segregation
process. |
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Data Capture and Analysis |
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Data can be read directly from Lab systems (pre stored at specified
locations) and populated on to CRF with no manual intervention. Appropriate data validation controls can be incorporated in CRF to ensure
data accuracy. |
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Audit Trail |
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The Data Base has details of changes and operations performed. Audit trial views can be organised
to suit different purposes. They can be data specific, user specific or defined as per audit needs. |
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Statutory Compliance |
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The system is compliant with 21 CFR 11, Indian GCP, ICH-GCP guidelines. |
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For further details and a personal discussion, please get in touch with us.click here |
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