Data Management EDC
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We use ClinPlus Data Management (CPDM), a comprehensive 21 CFR Part 11 compliant SAS-based system for managing clinical projects including CRF tracking, data entry, and review.
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About ClinPlus Data Management (CPDM)
CPDM is a SAS AF application that enables you to utilize the power of SAS to develop unique data bases and screens for each study. Your data is entered into SAS data sets so that it is instantly accessible for analysis. From database design to end of study, CPDM provides the means to achieve efficient data processing. CPDM is flexible enough to support different workflow scenarios based on the needs. CPDM includes an array of features that facilitates page, record, and query tracking; review and cleanup cycles; complete audit trail maintenance; user and data set security, and more. By managing all of your data processing procedures with one system, you are ensured a smooth progression from entry of the first casebook to a clean and locked database.
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CPDM offers the following superior capabilities:
- CRF Tracking and Audit Trail Maintenance
- Database Structure and Screen Design
- Data Entry and Verification
- Data Review and Correction Cycle
- Study Management
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EDC
Clinesian can take several approaches to Electronic Data Capture (EDC). It is our
intention to provide an EDC solution tailored to our clients needs for a particular study.
If a client has a preferred methodology including software and hardware infrastructure
for EDC, Clinesian is capable of providing services around different EDC vendor
products.
If a client is not familiar with EDC Clinesian will work with the client to evaluate and
choose an EDC vendor. We will cover all aspects of EDC including the design of
electronic case report forms (eCRFs), hosting solutions and the evaluation of the
investigator sites for EDC capability.
Since it is always our intention to provide easy to implement and flexible solutions,
Clinesian can offer its own comprehensive EDC services using open source EDC
software. This will include all eCRFs design, edit checks, querying, hardware
implementation and evaluation of investigator sites.
Clients can be assured that our EDC implementations adhere to good clinical practices
(GCP) and that our computer systems are 21 CFR 11 compliant for the management of
electronic records and electronic signatures.
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