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 approaches every data management task with consultation. Croissance will collaborate with you to identify your final objectives and offer knowledgeable input to help you get there quickly and effectively. Croissance still offer a high-quality infrastructure of data management fundamentals with process flexibility.
- Croissance 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 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 will help you understand the critical elements of data management, and how each item impacts other stakeholders.
Study Set-up
CRF design
CRF&e-CRF
design
Data
management plan
Data base
design
Data
validation
User acceptance
test
Study Conduct
IWRS
(Randomisation & Cent Allocation)
Query
management
Medical
coding
SAE reconciliation
Standard & Customized Reports
for Data Review & Metrics.
Study Close Out
QC
report
Data base
Lock
Final DB lock
readiness
Data
transfer
Study close
out & archival
Study closure
Documentation
Database Audit
by QA
