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EDC |
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Quartesian 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, Quartesian is capable of providing services around different EDC vendor
products.
If a client is not familiar with EDC Quartesian 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,
Quartesian can offer its own comprehensive EDC services using open source EDC
software (Openclinica). 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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