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
Source Credit: Figures reflect LezDo TechMed company-level performance data. Accuracy is measured as agreement with second-level QA review, and turnaround reflects routine medical-necessity cases. These are company-level averages, not a guarantee for any individual claim.
What Is Clinical Trial Record Review?
Clinical trial record review is the systematic verification and abstraction of source documents against the trial protocol and ICH-GCP E6(R2) standards to confirm data accuracy and regulatory readiness before database lock. LezDo TechMed supports biotech sponsors, pharmaceutical companies, and CROs with source document verification (SDV), clinical data abstraction, MedDRA adverse-event coding, and regulatory submission support across Phase I to IV trials, with 99.8% data accuracy across 250+ supported trials.
Source Credit: Figures based on LezDo TechMed clinical-trial engagements as of 2026. Accuracy reflects an aggregate average, not a per-project guarantee.
Key Takeaways
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Clinical trial record review confirms that trial data matches source documents under ICH-GCP E6(R2) before database lock.
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Core services: source document verification (SDV), clinical data abstraction into eCRFs, MedDRA adverse-event coding, and regulatory submission support.
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SDV can be 100% or risk-based; risk-based SDV is endorsed by ICH-GCP E6(R2) and FDA risk-based monitoring guidance.
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LezDo TechMed reports 99.8% data accuracy across 250+ trials and 50,000+ patient records, with 5 to 7 day 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
Clinical data abstraction is the extraction of protocol-required data points from source documents into electronic case report forms (eCRFs), following ICH-GCP standards and pre-specified data conventions. 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)
Source Document Verification (SDV) is the process of confirming that data recorded in a trial's case report forms matches the original source documents, such as hospital records and lab results. SDV may be 100% (every data point checked) or risk-based (a targeted sample), per ICH-GCP E6(R2). 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 coding is the standardized classification of adverse events using the Medical Dictionary for Regulatory Activities (MedDRA), enabling consistent safety reporting across regulatory submissions worldwide. 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
Regulatory submission support is the compilation and quality review of clinical documentation, including CSR narratives and CTD Module 5 datasets, to prepare an IND, NDA, or BLA package for FDA or EMA review. 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 II a Proof-of-Concept
Phase II b 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.
5 to 7 day SDV turnaround through efficient data abstraction and source document verification
Strong ICH-GCP compliance and inspection readiness for FDA/EMA inspections
Reduced CRO workload and operational costs by supplementing in-house teams
99.8% data accuracy across 250+ trials with fewer queries and rework through 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
100% SDV vs Risk-Based SDV: What Is the Difference?
Feature
100% SDV
Risk-Based SDV
What it verifies
Every data point in every case report form is checked against the source documents.
A targeted, risk-weighted sample of critical data points and higher-risk sites is checked against the source documents.
Best suited for
Small studies, early-phase trials, and safety-critical or primary-endpoint data.
Large, multi-site Phase II to IV trials where checking every data point is not feasible.
ICH-GCP E6(R2) stance
Permitted, but no longer required as the default monitoring approach.
Endorsed by ICH-GCP E6(R2) and FDA risk-based monitoring guidance as a quality-focused approach.
Monitoring effort and cost
Highest effort and cost, since every field is source-verified.
Lower effort, concentrated on the data most likely to affect trial conclusions.
Primary goal
Maximum source-verification coverage across the dataset.
Protecting data integrity and patient safety by focusing on the highest-risk data.
How LezDo TechMed supports it
We perform full 100% SDV where the protocol or sponsor requires it.
We perform risk-based SDV against a predefined monitoring plan and flag discrepancies for your team's review.
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
Source Credit: Figures reflect the results of a LezDo TechMed client engagement and are not a guarantee for any specific case. Results vary by claim volume, record complexity, and workflow.
Frequently Asked Questions
Seeking clarification on our clinical trial review support services? Get your answers here!
