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Data Management

Ethicare provides full data management services for all types of studies regardless of whether you’re conducting a small, single Phase I trial or multiple, complex Phase III trials.

Quality and Flexibility

Our Data Management team ensures that your project is collecting and managing clinical data reliably, efficiently and in compliance with industry and government regulations. We offer a maximum of flexibility for conducting trials with EDC, paper CRFs or a combination of both. We provide standalone Data Management Services and as a part of End-to-End Clinical Trial Services.

Clinical Data Management Services:

Electronic Data CaptureProject Management
Paper CRF studies – Manual Data Entry and peer review Diversified use of different EDC platforms based on the client requirements
Quality Assurance audits Quality Assurance audits
Study Start-upStudy ConductStudy Close out
Data Management inputs in Study outline and Study protocolCRF Tracking and ScanningDatabase Quality Audit
Case Report Forms (CRF) DesignCase Report Forms (CRF) DesignData Extract, listing and reports
CRF/eCRF annotation Data EntrySelf evidence correction listing
Data Management Plan (DMP)Lab Normal ManagementMedical terminology coding using MedDRA and medication coding using WHODRUG
Data Validation Plan (DVP)CRA / Medical Monitoring ReviewData Reconciliation like Laboratory data, SAE / AE, Medical History
Self-Evidence Correction Plan (SECP)Data Clarification Form (DCF)Database soft lock/ hard Lock/ Interim lock
Database Designing and programming in accordance with regulatory guideline and standards like CDISC - CDASH/ SDTMStatus and Tracking ReportsData Output for statistical analysis
Edit Check Specifications (ECS)and ProgrammingPatient Related OutcomesData Transfer
Database ValidationQuality Control on each data handling process
User Acceptance Testing (UAT)Discrepancy Management: Data cleaning and query management
User Access ManagementMedical terminology coding using MedDRA and medication coding using WHODRUG
CRF Completion guideline developmentOngoing support including user training and helpdesk operation
External Data Agreement plan (e.g. Lab, ECG, Device data etc)
Database Deployment
End-User training
Completed stand-alone CDM Projects
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Data Listing
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Pages
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Queries / DCFs
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Data fields developed in eCRF
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Laboratory Data reconciliation
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Medical coding (MedDRA)
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Safety Data Reconciliation
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Clinical Data Management Primers:

  • Defined SOPs for all processes
  • Faster and efficient database built-up
  • Robust validation checks to deliver error free database
  • Early identification of project / site trends and advising mitigation actions
  • Real time data review and reconciliation of the external data
  • A strong cross functional & proactive communication to ensure database lock is achieved within the pre-defined time frame
  • Robust IT infrastructure ensures your data security, privacy & uninterrupted services
  • Independent review for each document
  • 24x7x365 Helpdesk Support
  • Audit Trail provides detailed event tracking.
  • User-Friendly Design & Usability ensures easy implementation across the sites.
  • Randomization using Interactive Responsible Technology (IRT) for unbiased treatment allocation and accurate labeling.

Data Management Process

Data Base Creation and Validation

Data Collection, Entry And Review

Query Cycle and DB lock

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