CDM Research Outsourcing Services
Our CDM research outsourcing services streamline clinical trial data capture, cleaning, and validation, ensuring high-quality, audit-ready data submissions to global regulatory authorities.
Our CDM Research Capabilities
Our experienced data managers, clinical programmers, and QA teams deliver complete CDM solutions from CRF design to database lock with robust SOPs and traceable audit trails.
Types of CDM Research We Handle
- CRF Design and Annotation
- Electronic Data Capture (EDC) Setup
- Paper-Based Data Entry and Double Data Entry
- Clinical Database Build and Validation
- Data Entry and Data Cleaning
- Query Management and Resolution
- Data Coding (MedDRA, WHO-DD)
- Discrepancy Management
- Data Validation Plan Development
- Data Review and Reconciliation
- Serious Adverse Event (SAE) Data Review
- Lab Data Management
- Patient Reported Outcomes (PRO) Data Handling
- Safety Data Reconciliation
- Data Listing and Summary Generation
- Data Export for Biostatistics
- Data Transfer to Sponsors
- Data Lock and Database Freeze
- Interim and Final Data Extracts
- Database Migration Support
- EDC User Access Management
- Audit Trail Review and Archiving
- Regulatory Audit Preparation
- Compliance with ICH GCP Guidelines
- Multi-Center Study Data Coordination
- Clinical Study Data Standardization
- Customized CDM Workflows
- CDM SOP Development and Training
- Long-Term CDM Project Support
- Custom CDM Consulting Services
Key Research Outsourcing Services Offered
- Custom CRF and eCRF Design
- EDC Configuration and Validation
- Data Entry (Remote and Onsite)
- Double Data Entry Checks
- Data Cleaning and Edit Checks
- Query Generation and Resolution
- Medical Coding and Coding QC
- Discrepancy Management Reports
- Lab Data QC and Reconciliation
- SAE Reconciliation with Safety Database
- Data Review Listings and Summaries
- Interim Database Lock and Unlock
- Final Database Lock and Transfer
- Data Archival and Storage
- Audit Trail Extraction and Review
- Regulatory Submission Data Prep
- Real-Time Data Access for Sponsors
- Progress Reports and Data Metrics
- Secure Data Backup Solutions
- Confidential Data Handling with NDA
- Detailed SOPs and Technical Manuals
- On-Demand Data Export for Biostatistics
- Publication-Ready Data Tables
- Regulatory Compliance Documentation
- Training Workshops for CDM Teams
- CDM System Validations
- Multi-Center Site Data Coordination
- Post-Project Support and Updates
- Long-Term CDM Partnership Options
- Custom CDM Strategy Consulting
Why Choose Us for CDM Research Outsourcing?
Our CDM experts ensure clean, validated, regulator-ready datasets with efficient query handling, data security, and traceable audit trails for smooth submissions.
Industries & Sectors We Serve
- Pharma and Biopharma Sponsors
- Clinical Research Organizations (CROs)
- Medical Device Companies
- Academic Clinical Trial Units
- Regulatory Submission Consultancies
- Global Clinical Trial Coordinators
Customized CDM Solutions
We design flexible CDM workflows, CRF templates, and data review processes aligned with your study design and regulatory timelines.
Quality Assurance & Regulatory Compliance
Our CDM workflows comply with ICH GCP, CDISC standards, and sponsor SOPs, ensuring audit-ready, validated clinical datasets.
Case Studies & Client Success Stories
See how our CDM services have ensured zero audit findings, faster query turnaround, and submission-ready databases for global clients. References available on request.
How It Works: Our Research Outsourcing Process
- Requirement Gathering: Understand study protocol, endpoints, and CRF flow.
- Proposal & Quotation: Provide CDM plan, cost estimate, and timeline.
- Execution and Data Cleaning: Perform data entry, cleaning, and discrepancy resolution.
- Data Reporting: Deliver validated data listings, lock reports, and submission-ready extracts.
- Post-Project Support: Offer consulting for regulatory queries and data audits.
Frequently Asked Questions (FAQs)
Q: Do you handle multi-center study data?
A: Yes — we coordinate site data, queries, and validation across global centers.
Q: Can you support hybrid paper-EDC studies?
A: Absolutely — we manage both paper and electronic data streams efficiently.
Q: How secure is the clinical trial data?
A: NDAs, encryption, and strict access controls guarantee complete data confidentiality.
Get Started / Request a Quote
Contact us today to discuss your CDM project and receive a tailored plan and quote to align with your submission timelines.
Contact Us
Email: research-outsourcing@nthrys.com
Phone: +91-8977624748