Clinical Data Management Services

Clinical Data Management services

The complexities and costs of clinical data management have shown a significant increase with cross-national, multi-centric trials and data collation from multiple sites. For Consistent data quality, you can't sacrifice your timeline or budget.

Our systems, SOPs and project personnel are equipped to provide cost-effective and secure Clinical Data Management services efficiently. Our skilled project teams, have developed the expertise to deliver projects on time, with adherence to sponsor and protocol specific requirements.

Clinical Data Management services to support to Phase II-IV clinical trials and Enabling EDC and eCRF. ICBio being one of the top clinical data management companies in Bangalore provide Clinical Data Management Services which helps you achieve flexibility, accuracy and faster time-to-market, thereby ensuring that the objectives of your clinical trials are met.

From database build to database lock, ICBio is committed to customizing data management solutions that emphasize transparency, integrity and accountability as much as speed and accuracy. Our clinical data management team produces results that are source-verified, reproducible and cost-efficient which shows as one of the perfect clinical data management companies in India. In addition with the other services we provide contract research services, clinical laboratory services and BA/BE studies in clinical research.


Services offered:


  • Database Design and Validation
  • Data Entry Screens
  • Remote Data Entry (RDE)CRF Log and Tracking
  • CRF Review
  • Double Data Entry and Verification
  • Clinical Data Review
  • Query Generation and Resolution
  • Correction Processing
  • Audit Trail Generation (Per 21CFR Part 11)
  • Adverse Event and Concomitant Medication Coding
  • Data Quality Reviews and control
  • Database Lock and Archiving
  • Database Status Updates
  • SAS Data base designing
  • Report Generation (Business Objects and Crystal Reports)
  • Compliance with 21 CFR Part 11
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Departments
Quality Assurance
Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.

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Clinical Development
Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.

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Bio Analytical
ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.

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Project Management
ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.

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Biostatistics
Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.

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