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The following services are offered for studies hosted by
SciAn Services Inc.: ( Sample Process Timeline )
- Development
of Data Management Plan
We will work closely with you to establish a Data Management
Plan that ensures clinically meaningful analysis-ready
data is made available sooner.
- Clinical
Development of CRFs and Data Validation Plan
The objectives presented in your clinical study protocol
are extracted by our clinical research group and used
to construct preliminary paper-based CRFs. Once the paper-based
CRFs are finalized, a comprehensive Data Validation Plan
describing the extent and scope of edit checks for each
data field is produced.
- eCRF
& Database Design
Our development team then converts the paper-based CRFs
into eCRFs.
- Programming
Online Data Validation
Your clinical study database will start to take form as
complex validation rules, as outlined in the Data Validation
Plan, are embedded into the custom application template.
- Testing,
Documentation, Training & Deployment
Your clinical study database is released for your review
and testing. After approval, the training database is
available for interactive site training via web-conferencing.
Our clean, intuitive, and user-friendly interface generally
results in database training sessions that run for no
longer than 1 hour.
- Site
Monitoring / Source Data Verification
- Central
Data Review
Central data reviews will ensure the clinical and medical
consistency of the data.
- Medications
& Adverse Events Coding
- SAE
Management
- Database
QA, Lock, Release & System Decommission
We will perform an audit prior to database lock. Analysis
ready data will be exported to a preferred data analysis
tool or application (ASCII, SAS, Oracle, Excel, etc). The database release includes a complete database documentation with a database report and annotated CRFs. Once a project is completed, the system is decommissioned.
- Support
Professional and responsive support is provided to users
throughout the clinical study.
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Sept 21, 2005
White Paper on edcpro
2.00 available upon request more>>
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Thursday,
Nov 3, 2005
edcpro
Webinar to launch release of v3.00. Please contact
us to register. more>> |
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Spring
2006
2-day Seminar on novel trial design for biotech - includes
demo of edcpro
3.00 more>> |
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