Clinical Data Management

Ensuring patient safety and confirming efficacy in clinical development hinges on capturing quality trial data. At Croissance Africa, our clinical data management team delivers the optimal solution for your clinical trial, facilitating swift and effective research progression while safeguarding data integrity and quality from patient enrollment to database lock.

Under one roof, we handle all facets of data management, including database development, data cleansing, query resolution, database locking, and archiving. Our dedicated team members prioritize building relationships rooted in openness, efficiency, and quality, resulting in accurate and clean clinical trial data, cost-effective data administration, shortened time to database go-live, a user-friendly clinical database, and expedited database locking.

Flexible and Customized Data Management Solutions

Croissance Africa understands that each clinical trial is unique and offers flexible, customized solutions to meet your specific needs. Our consultative approach ensures collaboration with you to identify final objectives and provide knowledgeable input to achieve them quickly and effectively. While maintaining a high-quality infrastructure of data management fundamentals, we offer process flexibility to adapt to evolving project requirements.

Our Consultative Approach

• Early Consultation For EDC Solutions: We engage with you early to determine the appropriate Electronic Data Capture (EDC) solution based on your current programs and future pipeline. Our proactive planning helps balance short-term goals with long-term vision to support each phase of your programs.
• Driving Deliverables: Croissance Africa drives key interim and final deliverables based on our specialized knowledge of project requirements and the steps needed to accomplish each milestone.
• Understanding Data Management: We guide you in understanding the critical elements of data management and their impact on other stakeholders, ensuring alignment and clarity throughout the process.

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