EDC & Data Management
Quality and Reliability Are the Pillars of Our Approach
Our systems and processes are designed to ensure data integrity and regulatory compliance while providing the adaptability needed to meet the unique requirements of every study.
Our databases are 21 CFR Part 11 and CDISC-compliant, featuring full audit trails and other essential quality safeguards. Whether your program involves early-phase, fast-moving cohorts or large-scale, late-phase studies, our dedicated teams deliver clean, reliable data, quickly and efficiently.
Why Choose Lotus?
- Best in class established solution
- Full service: EDC, CTMS, eTMF
- 21 CFR part 11 and Annex 11 compliant
- Ease of use for both Site and CRAs
- Real-time dashboards to support ongoing decision making
- Quick set-up during study start up period
- CRO preferred partner relationship
We ensure that every data point collected is accurate, compliant, and ready for analysis.
Specialized Teams for Specialized Data Needs
Early Development Support (EDS)
Experienced in the rapid, cohort-based environment of Phase I and II trials, our EDS team ensures fast data cleaning and delivery of customized safety reports to enable next-cohort decisions.
Late-Phase Data Management
Our late-phase specialists support complex, global programs that demand scalable infrastructure and rigorous consistency across large datasets.
Core EDC and Data Management Capabilities
Combining robust technology with experienced oversight, we deliver flexible, high-quality solutions that streamline data collection, accelerate cleaning, and uphold the highest standards of scientific and regulatory integrity.
Study Build
- Veeva EDC
- Programming from Protocol to create Design Specifications and CRF’s.
- Leverage CDISC standards, forms and edit checks
- Internal and Sponsor Reviews
- Lotus Team full UAT, Sponsor can participate
- Internal and Sponsor Approvals prior to Go-Live
- Standard or Phased Go-Live
Study Plans & Documents
- System Design Specifications
- Blank and Annotated eCRFs
- Edit Check Specifications
- UAT Test Scripts
- Data Management Plan
- Medical Coding Conventions
- eCRF Completion Guidelines
- Data Transfer Agreements
Data Collection, Review, Cleaning
- EDC and external data reconciliations
- EDC query management
- DQRS – Manual Data Review and queries
- Protocol Deviation Query Management
- Medical Monitoring Oversight
- Medical Coding Oversight
- Proactively Freeze clean subjects
- Upload documents to the eTMF throughout the study
Database Lock Process
- Database Lock Checklist
- All data entered
- All queries resolved
- SDV complete
- Reconciliation complete
- PI Signature complete
- Database Lock Authorization Form will document sign-offs and completion of activities
- EDC access set to ‘view only’
- Final casebooks sent to sites and uploaded to eTMF
Data Metrics & Reporting
Our automated systems generate real-time metrics and reports on data entry, cleaning, and review. All reports are stored in a centralized, accessible repository, allowing your team to monitor progress anytime.
Training & Site Support
We ensure that every user is confident and capable. Lotus provides:
- Online training and data entry guides for site staff.
- Custom training by role (investigator, coordinator, CRA, etc.).
- Live or recorded sessions through investigator meetings or digital platforms.
Integration with External Data Sources
Many trials rely on data from multiple sources including IWRS, ePRO, eCOA, central and local labs, radiology, PK, and wearable devices. Our data management team oversees receipt, reconciliation, and integration of all external datasets under clear Data Transfer Agreements, ensuring consistency and timely availability for statistical analysis.
We also have extensive experience managing local lab data, including dynamic handling of varying normal ranges by site, patient demographics, and test parameters.
Medical Coding
Our experienced team supports medical coding in MedDRA (unique terms) and WHO Drug Global (by medication, indication, route, and country) using the Veeva CDMS coding module. We maintain compliance with biannual dictionary updates and provide full support for version upgrades when required.