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Clinical Data Management

Significance of Clinical Data Management Services
Importance of Clinical study is to re-produce clinically significant safety and efficacy data.
CDM assists in generation of high quality, reliable and statistically acceptable data from the clinical trials by implementing various procedures like database designing, validation, CRF designing, CRF Annotation, data entry, discrepancy management, medical coding, data extraction and data base locking at frequent intervals during clinical trial process.
CDM meets the demands of submitting data electronically by implementing regulatory compliant tools.
Why us?
Ensuring Clinical Data Integrity and Quality
Abiding to Clinical Data Management Best practices
Domain rich expertise
Technically sound team
Our Services
Designing and Setting up Clinical database
User Accepting Testing in EDC systems
Data validation
Developing of paper CRF/eCRF
Printing and distribution of Paper CRF
Tracking Paper CRF
Double- data entry -paper CRF
Deliverable clinical database is developed using CDISC SDTM standard
Data definitions are provided in accordance with CDISC CRT-DD specification
Integration of transferred data into clinical database
Discrepancy Management
SAE reconciliation
Coding Medical terminology (adverse events, medical history, medications)
Clinical database locking
Transferring Clinical database transfers (interim, final)
SAS datasets output
SAS EXPORT transport files
Contact Email ID: info@hezemon.com
Visit: www.hezemon.com
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