Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Clinical Data Management Support
From CRF design assistance to database lock, we provide comprehensive CDM support for data quality, integrity, and regulatory compliance in your clinical trials.
End-to-End Clinical Data Management Support
We support your organization across the complete data management lifecycle—from CRF design assistance through database lock and SDTM delivery. Our experienced CDM team integrates with your operations to support high-quality, clean data prepared to regulatory standards.
As your CDM support partner, we bring technical expertise, CDISC knowledge, and meticulous attention to detail that protects data integrity on the way to database lock.
Our approach
How We Support Your Data Management
- 01
Database Setup Support
We assist with CRF design review, EDC configuration, and validation rule development, designed for robust data capture from the start.
- 02
Ongoing Data Operations
Throughout the trial, we support data entry, conduct quality checks, manage queries, and perform medical coding to maintain data quality.
- 03
Database Cleaning
We coordinate data cleaning activities, resolve outstanding queries, reconcile discrepancies, and prepare databases for lock.
- 04
Database Lock & Delivery
Upon cleaning completion, we support database lock procedures and CDISC-conformant dataset creation for statistical analysis.
Deliverables
What You Receive
Data Management Plans
Comprehensive DMPs outlining data handling procedures, quality checks, and timelines for your trial.
Quality Check Reports
Regular data quality reports identifying issues, trends, and action items to maintain data integrity.
Query Reports
Detailed query tracking with resolution status, aging metrics, and site-level performance indicators.
Medical Coding
Accurate MedDRA and WHODrug coding with version control and audit trails for regulatory compliance.
Clean Databases
Locked, validated databases ready for statistical analysis with full documentation and traceability.
SDTM Datasets
CDISC-conformant SDTM datasets with define.xml and reviewer’s guides for regulatory submissions.
Why Prequel
The Prequel Advantage
CDISC Expertise
Data managers experienced in SDTM, ADaM and CDASH standards, for submission-ready deliveries.
Planned Path to Database Lock
Proactive data cleaning and continuous query management shorten the path to database lock.
Quality First
Independent QC built into our data processes, supporting data integrity and regulatory inspection readiness.
System Flexibility
Experience across commonly used EDC platforms; the specific systems are confirmed during scoping.
When you need us
Common Scenarios
Peak Enrollment Period
Data volumes are surging during peak enrollment and your team needs additional capacity to maintain quality and timelines.
Database Lock Deadline
You have an approaching database lock deadline and need experienced resources to complete cleaning and query resolution.
CDISC Expertise Gap
Your trial requires SDTM deliverables but your team lacks CDISC mapping expertise.
Quality Issues
You’re experiencing data quality problems or high query rates and need expert support to identify root causes and implement solutions.
Related support services
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Ready to Enhance Your Data Quality?
Let’s discuss how our CDM support services can strengthen your data management, from database setup through to lock.