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| Home > What We Do |
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| Clinical Data Management |
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We provide ICH-GCP and FDA compliant Clinical Data Management services through a fully secure, access controlled state-of-the-art delivery set-up in
Mumbai, India comprising best-in-class systems:
- ClinTrial 4.6 & Inform : Phase Forward’s leading Clinical Data Management Platforms for Paper CRFs and EDC.
- Rave : Medidata's web-based Electronic Data Capture (EDC) Platform for EDC trials.
- SAS 9.1.3 : Industry standard statistical software for statistical analysis.
- MedDRA 12.0 : ICH developed medical dictionary for medical diseases terminology coding.
- WHO-DD : WHO developed medical dictionary for concomitant medications.
We have a trained team of Project Managers, Data Managers, Bio-Statisticians, Medical Coders and Data Entry Associates with good understanding of
industry standard platforms,ICH-GCP/CFR guildlines, tools and technologies.
Our comprehensive training modules covers all aspects of the Clinical Data Management process from database design and study set-up, data entry
and verification, SAE reconciliation, data discrepancy management, data cleansing and extraction and database lock.
We further have a comprehensive suite of over 30 well-documented SOP’s to address each and every process in our DM project lifecycle.
Our Document Archival facility consists of an in-house access controlled, fire-proof, de-humidified, pest and insect controlled Central Archival
Unit with capacity to store upto ~ 1 Million CRF pages. We have further sub-contracted an additional facility through our storage partners that
meets defined GCP standards and can store upto ~ 5 Million CRF pages at anytime.
Our suite of data management services include:
- Study Design including Protocol/CRF/ICF
- Database Design, Testing & Validation
- Double Data Entry and Verification
- Data Discrepancy Management
- SAE Reconciliation
- Medical Coding
- Using Medical dictionaries MedDRA 11.1 and WHO-DD
- Bio-Statistics
- Statistical Analysis Plan
- Sample Size Calculation
- Randomization Schedule
- CRF Annotation
- Interim Statistical Analysis
- Final Statistical Analysis
- Analytical & Reporting Services
- Medical Writing
- Protocol design
- CRF Design
- ICF Design
- Investigator Brochure
- Final Study Reports ( ICH-E3 Formats)
- Medical Manuscripts
- ANDA submission documentation
- NDA submission documentation
- CTD/eCTD submissions using Knowledgenet & Liquent
- Safety & SAE Narratives
- Medico Marketing Support
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| Featured Case Study |
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| Karmic currently supports a Top 5 Global Pharmaceutical giant for data management across 15+ studies in multiple therapeutic areas over 14+ geographies across the globe |
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| read more >> |
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