Medical Data Analysis for Pharmaceutical Companies
Turning Every Medical Record into an R&D Advantage
Are you looking to strengthen your pharmacovigilance and mass tort litigations? LezDo TechMed's medical data analysis services should be your strategic assets. From day-to-day pharmacovigilance operations to high-stakes mass tort litigations, we provide 360° medical record review services for pharma with scalable, AI-assisted, human-in-the-loop solutions. Explore our full pharma case review services to see how we support drug safety and litigation teams end to end.
For every adverse event, safety signal, and lawsuit that comes your way, we support you with clear, speedy and defensible medical data analysis. Our AI-assisted, human-reviewed process flow is built to handle high volumes of medical data. Our precise reports help you meet global regulatory timelines for PV reporting and mass torts.
99.8%
Report Accuracy
360°
Medical Record Review
24/7
CaseDrive Access
3+
Regulatory Frameworks
Source Credit: Figures reflect LezDo TechMed company-level performance data. The accuracy figure is a company-level average, not a guarantee for any individual deliverable.
What Is Medical Data Analysis for Pharmaceutical Companies?
Medical data analysis for pharmaceutical companies is the structured review, organization, and summarization of patient and safety records for pharmacovigilance and mass tort litigation. LezDo TechMed uses AI-assisted extraction to flag documented adverse events, build medical chronologies, and prepare regulatory-ready documentation, and trained medical professionals validate every file before it reaches your safety, medical, or legal teams.
LezDo TechMed organizes, summarizes, and flags documented medical information for review by the appropriate qualified pharmacovigilance, medical, or legal professional. It does not determine drug-relatedness, causation, or liability. Those determinations remain with the qualified professional.
Key Takeaways
How Does LezDo Support Pharmacovigilance and Adverse Event Reporting?
LezDo TechMed supports your day-to-day pharmacovigilance operations with AI-assisted, human-in-the-loop medical record reviews that flag adverse events, organize the supporting documentation, and prepare audit-ready ICSR records. Trained medical professionals validate every file, so your safety team receives consistent, transparent, source-referenced output for FDA, EMA, and CDSCO reporting.
Adverse Event (AE) Detection & Verification
We map patient journeys through medical chronologies and flag documented drug-event timing, so your safety team can complete adverse event reporting and causality assessments.
Root Cause Analysis (RCA)
Our reviews organize and flag the documented factors behind a reported reaction, including co-morbidities, concurrent medications, and pre-existing conditions, so your pharmacovigilance scientists and physicians can assess drug-relatedness. LezDo organizes the evidence and does not determine causation.
Regulatory Compliance & Reporting
We assist you with medical data analysis reports that are audit-ready for data validation checks from FDA, EMA, CDSCO, and other regulatory bodies.
Trend Identification & Risk Minimization
We organize aggregated data so your safety team can review potential early safety signals for your Risk Management Plans (RMPs).
How Are Pharma Records Kept Secure and Compliant?
Every record is processed under HIPAA-compliant workflows with a completed SOC 2 Type II attestation and ISO 27001 certification, using encryption, secure file transfer, role-based access controls, and Business Associate Agreements. Outputs are prepared to meet the regulatory frameworks your submissions answer to, including FDA, EMA, and CDSCO.
How Do You Defend Pharmaceutical Mass Torts at Scale?
For high-stakes mass tort litigation, LezDo TechMed reviews, classifies, and prioritizes large claim volumes based on what the records document, and flags documentation gaps and potential alternative causes for the attorney's and medical expert's review. Our trained reviewers support dockets from a handful of claims to thousands, delivering medical chronologies, narrative summaries, and pattern analysis across the docket.
Documentation Gap Review
With expert record reviews, we flag documentation gaps and potential alternative causes for the attorney's and medical expert's review.
Claim Triage & Prioritization
We classify mass tort claims based on what the medical records document.
Evidence Preparation
Our medical chronologies and narrative summaries strengthen your evidence preparation.
Pattern Analysis Across Claims
We organize medical data across claims and flag documented inconsistencies for your legal team's review.
Therapeutic Areas We Support
How Our Pharma Medical Data Analysis Works
Secure Submission
Upload case files through our secure upload channel under HIPAA-compliant processes
AI Extraction
AI-assisted extraction of AE data, timelines, and documentation gaps
Expert Medical Review
Medical professionals validate accuracy before delivery
Report Formatting
Structured to your required format: ICSR, chronology, or custom
Delivery with Audit Trail
Timestamped delivery with source-referenced output.
The Difference We Bring
Strategic advantages that set us apart in pharmaceutical data analysis
High Scalability
From a single case to thousands of mass tort claims, our services can scale effortlessly to fit your estimates.
End-to-End Services
From medical data analysis for regulatory reporting to mass torts, we provide end-to-end clinical data analysis everything under one roof.
Secure Record Handling
Your records come in through our secure upload channel under HIPAA-compliant processes, and our account team keeps you updated on case status.
Human + Tech Advantage
We provide AI-assisted medical record reviews with expert human audit, backed by LezDo TechMed's published 99.8% company-level accuracy rate.
Case Success Story
Specialty Pharmaceutical Company
United States
Challenge
A US-based specialty pharma company managing post-marketing PV obligations across multiple indications was falling behind on ICSR processing timelines, risking regulatory action and consuming internal medical reviewer capacity that was needed for signal detection and RMP updates.
Solution
LezDo TechMed took over ICSR medical record review and narrative writing, processing cases within SLA turnaround with full audit trail documentation aligned to FDA and EMA submission requirements.
Results Achieved
99.8%
Accuracy Rate
2500+
ICSRs Processed in 90 Days
FDA & EMA
Built to help you meet regulatory deadlines
More Focus
On signal detection tasks
In-House PV and Mass Tort Review vs LezDo TechMed
Consideration
In-House PV/Mass Tort Review
LezDo TechMed Review
Turnaround
Depends on internal reviewer availability and can slow during adverse event or claim surges.
48 hours standard once scope is confirmed, 24-hour expedited where feasible; high-volume batches are confirmed at submission.
Scaling to volume
Bounded by headcount, so large mass tort batches create backlogs.
Scales from single PV cases to thousands of mass tort claims without adding to your payroll.
Report accuracy
Varies by reviewer and current workload.
99.8% company-level accuracy, with every file validated by trained medical professionals.
Output range
Limited by team bandwidth and specialty mix.
ICSR documentation, medical chronologies, narrative summaries, and regulatory-ready reports for FDA, EMA, and CDSCO.
Security and compliance
Depends on your internal controls and tooling.
HIPAA-compliant workflows with a completed SOC 2 Type II attestation and ISO 27001 certification.
Who makes the determination
Your staff both organize the records and make the clinical and legal calls.
LezDo organizes and flags the documented evidence; your scientists, physicians, and attorneys make the determinations.
Frequently Asked Questions
Looking for answers about medical record review services? Explore our FAQs.
