ELECTRONIC DATA CAPTURE

Eishasoft., 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, Eishasoft., is capable of providing services around different EDC vendor products.

If a client is not familiar with EDC, Eishasoft., 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, Eishasoft., 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.