| Versante provides comprehensive data planning and management services for Phase I-IV clinical trials, emphasizing strategic expertise in study design and data integrity to ensure validity of endpoints. Our qualified team of Statisticians, Forms Designers, Database Programmers and Data Managers will develop the Data Management Plan specific to your trial with close sponsor communication and integrate it with the Standard Operating Procedures to ensure successful and timely database development and management. |
| |
| Our Data Management Services Include: |
 |
|
Case Report Form (CRF and eCRF) design |
|
Database design |
|
Development of Data Management Plans |
|
Developing edit check specifications |
|
Edit check programming |
|
Developing CRF guidelines |
|
Data entry (if needed) and validation |
|
Query generation and resolution |
|
Coding of adverse events (MedDRA) |
|
Coding of concomitant medications (WHO) |
|
Preparing data for Data Safety Monitoring Board Meetings |
|
Locking databases |
|
Importing and exporting data |
|
Providing databases that are CDISC compliant |
|
Conversion of legacy datasets to meet CDISC Standards |
| |
|
