Thoroughly understanding statistics and clinical data management, we manage your data, to ensure quality and accuracy. Like a clinical trial, the data management process begins with the end in mind. We assist you in generating high-quality, reliable, and statistically sound data thereby reducing the time from development to submission.

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Data management including database setup is performed under strict quality assurance standard operating procedures and is 21 CFR part 11 and GCP compliant. We uphold the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

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We can set you up with an optimal solution for your needs and budget through strategic collaboration with two leading EDC software providers.

 

BioStats provides end-to-end clinical data management support from eCRF design through database lock and final study archival. Our services include:

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EDC building - Before Go live:

• Case Report Form (CRF) design and review

• CRF annotation

• EDC design technical advisement

• Edit checks programming & testing according to the CRF and the client’s requests

• Data Management Plan (DMP)

• EDC Trial Set-Up & Management

• Database Build & Design

• ePRO design if needed

• eICF – Electronic Consent Form

• eSource Documentation

• Randomization module setup

• Medical coding tools: MedDRA, WHODrug, etc.

• DICOM images integration

• GCP compliance

• Database internal validation by a third-party validator

• EDC access administration

• System training for sites and monitors

 

DM activities - After Go live:

• Data validation (Safety Data Management & Reconciliation)

• Discrepancy and query management

• Import, Integration, and Cleaning of External Data (Lab, ECG, PK, Diary, etc.)

• Users management

• Export functionality for all permitted users

• Development of Custom Periodic Reports – part of risk-based monitoring

• Database lock

• Helpdesk