Data management services
At DivergentCRO, we are committed to providing cutting-edge and cost-effective clinical management services to pharmaceutical, biotechnology, and medical device companies. Our approach combines technological innovation with operational excellence to ensure your clinical trials are efficient, compliant, and successful. From initial study design to final reporting, we provide end-to-end solutions tailored to your specific needs. Our goal is to accelerate your path to market while maintaining the highest standards of quality, regulatory compliance, and patient safety.
1. Clinical Data Management (CDM)
End-to-End Data Management: We provide complete management of clinical trial data from study setup to database lock, ensuring data accuracy, consistency, and regulatory compliance.
Electronic Data Capture (EDC): Our EDC platforms offer real-time data collection, tracking, and reporting, reducing the time from data entry to analysis. Our systems are customizable to meet the specific needs of any trial phase.
Data Cleaning and Validation: Leveraging automated and manual processes, we identify inconsistencies, missing values, and outliers to ensure high-quality data. Regular audits are performed to maintain regulatory standards.
Data Mapping and Migration: We specialize in migrating legacy data into modern systems, ensuring data consistency and minimizing errors during transfers.
2. Real-Time Data Access and Monitoring
Custom Dashboards: Our platforms provide sponsors with real-time access to trial data, allowing for on-demand monitoring and decision-making. We customize dashboards to provide a clear overview of study progress, critical metrics, and patient recruitment status.
Risk-Based Monitoring (RBM): Using advanced analytics and machine learning, we employ RBM to identify potential risks early in the trial, optimizing monitoring resources and reducing the need for frequent site visits.
Remote Data Monitoring: With the ability to monitor trial data remotely, we help reduce site visits and associated costs while maintaining data integrity and patient safety.
3. Advanced Analytics and Reporting
-Predictive Analytics: Utilizing artificial intelligence (AI) and machine learning, we offer predictive analytics to forecast trial outcomes, patient recruitment rates, and potential safety concerns, allowing for proactive decision-making.
Adaptive Trial Designs: Our data management system is flexible and adaptive, enabling sponsors to adjust trial parameters in real-time based on evolving data without compromising study integrity.
Data Visualization: We provide advanced visualization tools to present complex data in a clear, actionable format. Whether through graphs, heatmaps, or trend lines, our tools enhance the understanding of trial progress and results.
Real-Time Reporting: Automated reports are generated and shared with stakeholders, providing insights into key metrics, patient outcomes, and site performance. We ensure timely delivery of reports, adhering to regulatory deadlines.
4. Regulatory-Compliant Data Solutions
Audit Trail and Documentation: Our data management systems include detailed audit trails that track every modification made to the data. These trails meet regulatory requirements and are readily available for audits by health authorities like the FDA, EMA, and others.
Regulatory Submission Support: We offer support for regulatory submissions, including the preparation of datasets compliant with CDISC standards (SDTM, ADaM) and submission-ready documents.
Data Privacy and Security: With a robust infrastructure, we ensure compliance with international data protection regulations, including GDPR and HIPAA. Our systems use state-of-the-art encryption and secure cloud storage solutions to protect sensitive trial data.
5. Cost-Effective and Scalable Solutions
Pay-As-You-Go Pricing: We offer flexible pricing models, including pay-as-you-go and project-based pricing, allowing companies to scale their data management needs according to their trial requirements.
Cloud-Based Solutions: Our cloud-based platforms eliminate the need for costly hardware investments, offering a scalable, secure, and easily accessible solution.
Automated Processes: Leveraging automation reduces manual efforts, leading to faster data processing, reduced human errors, and significant cost savings throughout the trial.
Data Standardization: By adhering to industry standards (CDISC, MedDRA, WHODrug), we ensure that data is harmonized across all studies, enabling efficient integration and analysis, thus reducing the time and costs associated with reformatting data for submissions.
6. Integration with Other Systems
Interoperability: Our systems integrate seamlessly with other software and platforms (e.g., eTMF, IVRS/IWRS, safety databases), ensuring a smooth flow of information between different components of clinical trials.
Wearable and Remote Data Integration: We support data collection from wearable devices and remote monitoring technologies, enabling decentralized trials that can lower costs and increase patient participation.
7. Post-Study Data Management
Long-Term Data Archival: We offer secure, long-term data archiving solutions to store clinical trial data post-study. Our archiving solutions comply with regulatory requirements, ensuring data availability for future audits and inspections.
Data Mining for Future Studies: Utilizing historical data, we provide actionable insights that can inform future study designs, reduce redundancy, and optimize future clinical development plans.
8. Specialized Data Management Services
Biostatistics and Programming: Our expert biostatisticians design and analyze clinical trials using robust statistical methods. We offer data programming services in SAS, R, and other languages to ensure accurate and efficient analysis.
Real-World Evidence (RWE) Data Integration: We incorporate real-world data (RWD) into clinical trials, helping sponsors understand how their therapies perform in real-life settings and informing post-market surveillance.
Pharmacovigilance Data Management: Our systems support the management of safety data, including adverse event reporting and signal detection, ensuring patient safety throughout the trial lifecycle.
9. Training and Support
On-Demand Training: We provide comprehensive training programs for sponsors and site staff on how to use our data management systems efficiently. Training is available on-demand, ensuring that teams are well-equipped to navigate the data systems.
24/7 Technical Support: Our dedicated support team is available around the clock to resolve any issues related to data management systems, ensuring minimal disruption to your trial operations.