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FCRL through its Clinical Data Management Partner offers the full complement of Data Management services with experience in clinical trials ranging from Phase I - Phase IV. Data Management Services are dedicated to the highest Quality, Excellence, and Client Satisfaction through Project Management, Communication, and Execution of studies.
FCRL has developed a comprehensive Data Management Plan template which allows for rapid development of databases with our partners and encompasses the following:
Database design and validation
1. User access rights
2. Data processing
3. Query processing and resolution
4. Coding and QC guidelines Data transfers and data handling instructions
During project execution FCRL focuses on full team involvement and communication so that the end result is a clean database delivered on time.
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Hypertension |
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Type II DM |
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Urinary Tract Infection |
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Antidepression |
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RTI |
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Parkinson’s Disease |
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LRTI |
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Scizophrenia |
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Tonsillitis |
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Epilepsy |
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Piles |
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FRheumatoid Arthritis |
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Pneumonia |
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Hepatitis B |
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Ototis media |
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Alzheimer |
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Solid tumor |
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Cardiovascular |
Data Management systems used are Open Clinica 3.0.2 (Enterprise version) and Oracle Clinical. The team is fully trained on these applications and experienced in their use. Services provided by the team include:
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Protocol Review |
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Data Quality Assurance |
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Case Report Form (CRF) Review |
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Data Transfer |
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Case Report Form Design, Printing, Distribution, Collection, and Analysis |
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Parkinson’s Disease |
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Data Validation Specifications |
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SAE Reconciliation |
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Database Design |
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Data Management Reporting |
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Data Receipt, Logging, and Tracking |
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Data Review Meeting |
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Data Entry |
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Data Management Plan (DMP) Development |
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Query Management |
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DMP Review Meeting |
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Medical Coding |
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EDC Consulting |
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