Pharmacovigilance & Mass Tort Solutions

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 human AI solutions.

For every adverse event, safety signal, and lawsuit that comes your way, we support you with clear, speedy and defensible medical data analysis. With CaseDrive, our review tool, we have a scalable process flow to handle massive volumes of medical data. Our precise reports help you meet global regulatory timelines for PV reporting and mass torts.

99%

Report Accuracy

360°

Medical Record Review

24/7

CaseDrive Access

Global

Regulatory Compliance

Your Pharmacovigilance Challenges: Our Solutions

We support your day-to-day PV operations with medical record reviews, ensuring consistency, transparency and audit-readiness throughout the process.

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Adverse Event (AE) Detection & Verification

We map patient journeys through accurate medical chronologies and establish drug–event relationships, contributing to comprehensive adverse event reporting and causality assessments for adverse events.

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Root Cause Analysis (RCA)

Our medical record reviews analyze if the reported adverse reaction is directly drug-related or due to other clinical factors, aiding in post-marketing surveillance.

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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.

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Trend Identification & Risk Minimization

We assist you with aggregated data analysis to detect early safety signals and feed into robust Risk Management Plans (RMPs).

Regulatory Frameworks We Work Within

ICH E2B(R3)
21 CFR Part 11
GVP Module VI
PSUR / PBRER
DSUR
RMP

How We Simplify the Medical Record Maze for Mass Torts

We provide medical record review services for high stake mass tort litigations. Our mass tort medical data analysis covers:

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Case Strength Assessment

With expert record reviews, we expose causation gaps and unrelated conditions.

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Claim Triage & Prioritization

We classify the mass tort claims as per the strength of the medical evidence in the records.

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Evidence Preparation

Our medical chronologies and narrative summaries strengthen your evidence preparation.

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Pattern Analysis Across Claims

With precise medical data analysis, we identify inconsistencies in class action arguments.

Therapeutic Areas We Support

Oncology
Neurology
Cardiology
Immunology & Biologics
Rare Diseases & Orphan Drugs
Infectious Diseases
Women's Health
Gastroenterology

How Our Pharma Medical Data Analysis Works

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01

Secure Submission

Upload case files via CaseDrive's encrypted, HIPAA-compliant portal

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02

AI Extraction

AE data, timelines, and clinical gaps extracted in minutes

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03

Expert Medical Review

Medical professionals validate accuracy before delivery

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04

Report Formatting

Structured to your required format — ICSR, chronology, or custom

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05

Delivery with Audit Trail

Timestamped trail supporting 21 CFR Part 11 compliance

The Difference We Bring

Strategic advantages that set us apart in pharmaceutical data analysis

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High Scalability

From a single case to thousands of mass tort claims, our services can scale effortlessly to fit your estimates.

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Free Pilot Program

Our free pilot program helps you experience our process flow and understand how we support your business operations.

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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.

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Seamless Case Management

With us, you get the power of CaseDrive, our advanced case management tool where your cases are automated, organized, tracked, and delivered with precision.

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Human + Tech Advantage

We provide AI-assisted medical record reviews with expert human audit, delivering 99% accuracy in the final reports.

Try Before You Commit

Our free pilot gives you one complete case review — delivered through the full CaseDrive workflow, at the same 48-hour turnaround.

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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 through CaseDrive, processing cases within SLR 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

Zero

Missed Regulatory Deadlines

100%

Focus Shift to Signal Detection Tasks

Read Full Case Study

Frequently Asked Questions

Looking for answers about medical record review services? Explore our FAQs.

What is medical data analysis for pharmaceutical companies?
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What medical data analysis services do you provide for pharmaceutical companies?
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How do you support pharmacovigilance and adverse event reporting?
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How do you support pharmaceutical mass tort defense?
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How accurate are your medical data analysis reports?
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How quickly can you deliver reports for PV and mass tort cases?
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Can you handle large volumes of mass tort claims without affecting quality?
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How do you ensure data security and compliance for pharmaceutical records?
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What is the difference between root cause analysis and adverse event detection in medical record review?
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How do I get started with a pilot case?
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Ready to Strengthen Your Pharmacovigilance & Litigation Support?

Join pharmaceutical companies who trust LezDo TechMed for regulatory-compliant, defensible medical data analysis. Start with a free pilot program today.