Clinical Research Solutions
Clinical Trial Record Review & Data Services
Seeking fast, accurate, compliant data review and documentation support for clinical trial executions? We help biotech companies, pharmaceutical sponsors, and CROs maintain data integrity, meet ICH-GCP regulatory standards, and stay on track without slowing down operations.
250+
Clinical Trials Supported
50,000+
Patient Records Reviewed
99.8%
Data Accuracy Rate
5-7 days
SDV Turnaround
Operational Challenges in Clinical Trial Review
Clinical trials require high data standards, strict regulatory compliance, and tight deadlines, making the task hectic.
Protocol & GCP Compliance
Reviewing extensive trial documentation to confirm compliance with study protocols, ICH-GCP standards, and regulatory requirements.
Adverse Event Documentation
Identifying, classifying, and documenting adverse events (AEs) and serious adverse events (SAEs) from records for safety reporting.
Source Document Verification (SDV)
Validating CRF (case report forms) entries against source documents to ensure accuracy, completeness, and audit readiness.
Regulatory Submission Deadlines
Meeting FDA, EMA, and global submission deadlines while maintaining precise, inspection-ready documentation.
Comprehensive Clinical Trial Services
ICH-GCP compliant data services designed for biotech, pharma, and CROs
Clinical Trial Data Abstraction
Accurate extraction of critical clinical data from source documents, medical records, and CRFs to support database population and clinical study reports.
ICH-GCP compliant processes
eCRF data population
Query resolution support
Source Document Verification (SDV)
Thorough 100% or risk-based SDV to validate trial data, identify discrepancies, and strengthen data integrity for regulatory audits.
100% or risk-based SDV
Discrepancy identification
CAPA documentation
Adverse Event Coding & Reporting
MedDRA-based adverse events (AEs) and serious adverse events (SAEs) coding with detailed narratives, casualty assessment support and safety reporting support.
MedDRA terminology coding
SAE narrative preparation
Safety signal detection
Regulatory Submission Support
Clinical data review and compilation for IND, NDA, BLA, and global regulatory filings and inspections, including clinical study reports (CSR).
CSR compilation support
ISS/ISE preparation
Module 5 documentation
Comprehensive Support
Clinical Trial Services We Support
End-to-end coverage across phases, therapeutic areas, and submission needs
Early Phase Trials
Phase I Safety Studies
Phase IIa Proof-of-Concept
Phase IIb Dose-Finding
First-in-Human Studies
Healthy Volunteer Studies
Late Phase Trials
Phase III Pivotal Trials
Phase IV Post-Marketing
Real-World Evidence Studies
Registry Studies
Long-Term Follow-Up
Regulatory Support
IND/NDA/BLA Submissions
Clinical Study Reports (CSR)
Integrated Summary of Efficacy (ISE)
Integrated Summary of Safety (ISS)
FDA/EMA Responses
Therapeutic Areas
Oncology & Hematology
Cardiovascular & Metabolism
Neurology & Psychiatry
Immunology & Infectious Disease
Rare Diseases & Orphan Drugs
Why Sponsors & CROs Choose LezDo TechMed
Partner with GCP-certified professionals who understand clinical trial operations and regulatory requirements.
Faster clinical trial timelines through efficient data abstraction and SDV
Strong ICH-GCP compliance and inspection readiness for FDA/EMA inspections
Reduced CRO workload and operational costs by supplementing in-house teams
Higher data quality with fewer queries and rework with expert record review
Scalable support across Phase I–IV trials without permanent headcount
Deep therapeutic expertise across 40+ specialties including oncology, neurology, etc.
Our Regulatory Expertise
ICH-GCP Certified Professionals
FDA 21 CFR Part 11 Compliance
MedDRA Coding Expertise
Audit-Ready Documentation
Clinical Trial Success Story
Mid-Size Biotech Company
Phase III Oncology Trial
Challenge
Biotech sponsor conducting global Phase III oncology trial with 450 patients across 75 sites faced delays in database lock due to high query rates and SDV backlog. Internal CRO team was overwhelmed, jeopardizing NDA submission timeline.
Solution
Deployed dedicated team for source document verification (100% SDV), medical history abstraction, and query resolution. Provided MedDRA coding for 1,200+ adverse events and prepared SAE narratives for regulatory submission.
Results Achieved
450
Patient records reviewed
42 days
Database lock acceleration
1,200+
AEs coded to MedDRA
On-time
NDA submission achieved
Frequently Asked Questions
Seeking clarification on our clinical trial review support services? Get your answers here!
