Overview of Services
Clinical Data Management
At Profoundex, we understand that high-quality data is the foundation of successful clinical trials. Our Clinical Data Management (CDM) services are designed to ensure data integrity, accuracy, and compliance throughout every phase of your study. From startup to close-out, we provide expert solutions tailored to your unique needs.
Startup, Conduct, and Close-Out of Data Management
We oversee the entire lifecycle of clinical trial data with meticulous attention to detail. From initial planning to final data delivery, our team ensures seamless execution by:
- Setting up data management processes aligned with regulatory and study-specific requirements.
- Monitoring and maintaining data quality throughout the study conduct phase.
- Managing database close-out and delivering cleaned, validated data ready for analysis.
eCRF Design & Protocol Review
The electronic Case Report Form (eCRF) is the backbone of clinical trial data collection. We design eCRFs that are intuitive, efficient, and compliant:
- Collaborating with your team to design eCRFs that align with study protocols.
- Ensuring eCRFs capture all critical data points while minimizing errors and redundancies.
- Conducting thorough reviews to confirm protocol adherence and usability.
Clinical Study Database Design
A well-designed database is key to efficient data management. Our database design services include:
- Creating customized clinical study databases that align with your trial’s specific needs.
- Incorporating features for easy data capture, validation, and reporting.
- Ensuring databases are scalable, secure, and compliant with industry standards.
Data Management Plan (DMP) Creation
The Data Management Plan is a critical document that outlines how trial data will be handled. At Profoundex, we develop comprehensive DMPs to guide every aspect of your study’s data lifecycle:
- Detailing data collection, cleaning, and validation procedures.
- Addressing key areas such as query management, coding, and reconciliation.
- Ensuring all processes are aligned with Good Clinical Data Management Practices (GCDMP) and International Conference on Harmonization (ICH) guidelines.
