Clinical Data Management
Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today
Our clinical data management team provides the optimum solution for your clinical trial, allowing your research to move as quickly and effectively as possible—without compromising the integrity and quality of the data—from patient enrolment to database lock. All aspects of data management are handled under one roof, from database development to data cleansing and query resolution to database locking and archiving. Our team members are dedicated to forming relationships that value openness, efficiency, and quality. The final result was accurate and clean clinical trial data, as well as cost-effective data administration, a shorter time to database go-live, a functioning and easy-to-use clinical database, and an accelerated database lock.
Flexible and Customized Data Management Solutions
Our Consultative Approach
Croissance Clinical Research Inc approaches every data management task with consultation. Croissance Clinical Research Inc will collaborate with you to identify your final objectives and offer knowledgeable input to help you get there quickly and effectively. Croissance Clinical Research Inc still offer a high-quality infrastructure of data management fundamentals with process flexibility.
- Croissance Clinical Research Inc will consult you early on to determine the right EDC solution for you, based on your current programs for your future pipeline. Croissance can help to balance short-term goals against long-term vision for your programs and plan proactively for each phase.
- Croissance Clinical Research Inc will ask questions to drive key interim and final deliverables to completion based on our niche knowledge of what is needed and the steps to achieve each milestone.
- Croissance Clinical Research Inc will help you understand the critical elements of data management, and how each item impacts other stakeholders.
Study Set-up
CRF design
CRF design
CRF&e-CRF design
CRF&e-CRF design
Data management plan
Data management plan
Data base design
Data base design
Data validation
Data validation
User acceptance test
User acceptance test
Study Conduct
IMP Allocation (Investigational medicinal product)
IMP Allocation (Investigational medicinal product)
Query management
Query management
Medical coding
Medical coding
SAE reconciliation
SAE reconciliation
Standard & Customized Reports for Data Review & Metrics.
Standard & Customized Reports for Data Review & Metrics.
Study Close Out
QC report
QC report
Data base Lock
Data base Lock
Final DB lock readiness
Final DB lock readiness
Data transfer
Data transfer
Study close out & archival
Study close out & archival
Study closure Documentation
Study closure Documentation
Database Audit by QA