Electronic Case Record Form (eCRF)

Electronic Case record form (eCRF) is the important record in the process of clinical research. eCRF are designed in a way that replicates the protocol of the study, as well facilitates full control of electronic data capture (EDC) collection, processing, monitoring, and reporting auditing the content of the filled-in eCRFs as per Internal SOP and ICH -GCP and Applicable Regulatory Authority.

The system provides a step-by-step design process, which allows for key trial components to be selected. It also helps structure interview questions, which can be easily grouped for more complex study designs. It is very important document as a part of regulatory requirements.

Electronic Case record form (eCRF) designing is an art of how to replicate the protocol required information in an accurate, compiled, concise and minimal text free response document that allows to record the project data in a standard format.

BizNET-CTM provides with a solution for designing electronic case record form. It allows to design the eCRF in complete adherence to the protocol and regulatory requirement. The design varies from protocol to protocol.

BizNET-CTM also allows to save the designed template which can be reused for similar sort of study designs. It allows designing eCRF in such a way that generates the clinical data in a highly organized and standardized format which can be easily archived and retrieved whenever needed.

Electronic Case record form (eCRF) not only saves to the cost of paper but also saves the time of re-designing the same sort of eCRF again and again. Also accelerate the data collection, review and approval process.

Features:

Intuitive eCRF designs to best suit the protocol

Cover All the Details and Key Point of Protocol

Allows designing eCRF as per regulatory requirements and ICH GCP

Design eCRF for Multi period/ Multi site studies

Design eCRF for BA/BE studies and Clinical Trials

Design eCRF for Multi-dose studies

Readily reusable Standard Libraries

Visit wise scheduling

User friendly designing tools

Allows to enter online validation criteria checks

Avoid duplication & Easy to Review the data for Audit

Generate automatic Discrepancy at Field level

Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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