Medrio’s Clinical Data Services (CDS) team is here to help you streamline the entire clinical development process. Our experts are ready to support you from database build to regulatory-ready outputs.
At Medrio, our CDS services include:
- Electronic Case Report Form (eCRF) and database build services
- Comprehensive data management services
- Biostatistics and statistical programming
Here’s what to know about our team of experts and the services they offer to support your next trial.
Want to learn more about what Medrio CDS can do for you? Connect with our experts.
About Medrio CDS Experts
Medrio’s Clinical Trial Data Services include 17 highly experienced professionals based in North America. Our experts bring nearly 300 years of combined industry experience across clinical data management, programming, and biostatistics.
All CDS activities are governed by Medrio’s comprehensive, audit-approved SOP framework. This process has been highly rated by multiple independent and sponsor audits.
Every step—from database build to database lock—is performed with the highest level of quality, traceability, and compliance.
Get the Foundation Right with Medrio eCRF and Database Build Services
A well-designed database is the cornerstone of every successful clinical study. Medrio’s CDS experts transform your protocol into a customized eCRF and database.
The process begins with a detailed review of your protocol and CRFs to develop an eCRF Build Specification (eCRF-BS) document. We collaborate with your study team in multiple review cycles. Together, we examine the database structure, visit schedule, edit checks, and system dynamics. This process makes sure all components support your study objectives.
Each Medrio CDMS/EDC database is configured with advanced logic, rules, and edit checks to ensure precision and efficiency. Comprehensive internal and external User Acceptance Testing (UAT) confirms every function performs exactly as intended.
Key eCRF and Database Build Services
Medrio’s eCRF and database build services help sponsors and CROs lay a solid foundation for their studies.
eCRF and database build services include:
- eCRF, ePRO, eConsent, and eSource build specifications and issues log
- Database configuration and setup
- Study-specific edit check programming
- Form review and UAT meetings
- UAT plan and UAT report with two external review cycles
- Database deployment and go-live
The Benefits of Medrio eCRF and Database Build Services
Medrio’s eCRF and database build services focus on speed, consistency, and compliance during study startup. The result is a streamlined build process that reduces rework and shortens timelines.
The benefits include:
– Protocol-driven, CDASH-compliant database builds
– Rapid configuration and expert setup
– Shorter startup timelines through streamlined review cycles
– Transparent documentation and change tracking
– Full compliance with ICH, GCP, and 21 CFR Part 11
Support Accuracy with Comprehensive Data Management Services
We offer clinical data management support for accurate, complete, and analysis-ready data. Our services follow industry standards like ICH, GCP, and FDA standards. All services are executed in validated, secure environments.
Standardized workflows and templates provide quality and consistency from case report form design through database lock. Data is validated in accordance with CDASH standards. Any discrepancies are managed through query resolution, and medical coding is performed using MedDRA and WHO-DD.
Key Data Management Services
Our team of data management experts works with sponsors and CROs to ensure accurate, complete data for analysis.
Medrio’s data management services include:
- Data management plan (DMP) development
- eCRF design and development
- Edit check programming and testing
- Query management and data validation
- Third-party data integration and import
- Medical coding for adverse events, medical history, and concomitant medications
- Serious adverse event reconciliation and safety data management
- Interim analysis and database lock support
- Role-based EDC training and account management
The Benefits of Medrio Comprehensive Data Management Services
Medrio’s data management services enable faster decision-making and smoother progress toward database lock.
The benefits include:
– Real-time access to accurate data
– SOP-driven quality and consistency
– Accelerated timelines to database lock
– Secure and validated data environment
– Tailored workflows to meet sponsor and regulatory needs
Transform Your Data into Insights with Biostatistics and Statistical Programming
Medrio’s biostatistics and programming experts make sure your study data is transformed into regulatory-ready insights. Our team gets involved early in study design and collaborates closely with data management to guarantee clean data and reliable analyses.
Our statisticians have deep experience across all trial phases, applying validated methodologies that align with FDA, EMA, and ICH requirements.
Key Biostatistics and Statistical Programming Services
Medrio’s biostatistics and statistical experts work with CROs and sponsors to transform their data into insights.
Medrio’s Biostatistics and Statistical Programming Services include:
- Protocol review and statistical consultation
- Sample size calculation and randomization schedules
- Statistical analysis plan (SAP) development
- SAS programming and independent validation
- Interim, topline, and final analyses
- SDTM and ADaM dataset generation
- ISS/ISE and FDA reviewers’ guide preparation
The Benefits of Medrio Biostatistics and Statistical Programming
Medrio’s biostatistics and statistical programming services are built to provide confidence at every stage.
The benefits include:
– 100% validated datasets and deliverables
– Continuous collaboration from kickoff to submission
– Efficient handoff between Data Management and Statistics team
– Full CDISC compliance for regulatory submission
– Proven expertise aligned with global standards
Why Partner with Medrio Clinical Data Services?
By offering EDC, data management, and biostatistics under a single organization, Medrio delivers unmatched data integrity and operational continuity.
This unified model eliminates silos, accelerates database build and validation, reduces communication gaps, and improves overall study quality.
When you partner with Medrio, you gain more than a technology vendor. You gain a scientific partner committed to your study’s success. Whether you need a compliant eCRF build or end-to-end data management and biostatistical support, Medrio is here for you.
Want to learn more about what Medrio CDS can do for you? Connect with our experts.