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, 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. 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.

99.8%

Report Accuracy

360°

Medical Record Review

24/7

CaseDrive Access

3+

Regulatory Frameworks

Source Credit: Figures reflect LezDo TechMed company-level performance data from the CaseDrive platform. 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's CaseDrive platform extracts adverse events, builds medical chronologies, and prepares 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

Covers both pharmacovigilance operations and mass tort litigation, from adverse event and ICSR records to high-volume claim files.
Standard turnaround is 24 to 48 hours (company-level average; high-volume mass tort batches are confirmed at submission).
Delivers ICSR documentation, medical chronologies, narrative summaries, and regulatory-ready reports for FDA, EMA, and CDSCO submissions.
AI-assisted, human-in-the-loop workflow: CaseDrive extraction is validated by trained medical professionals before delivery.
Processed under HIPAA-compliant workflows with a completed SOC 2 Type II attestation and ISO 27001 certification.
LezDo organizes and flags documented evidence for the qualified pharmacovigilance, medical, or legal professional. It does not determine drug-relatedness, causation, or liability.

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.

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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 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.

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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).

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 end-to-end encryption, role-based access, and Business Associate Agreements. Outputs are prepared to meet the regulatory frameworks your submissions answer to, including FDA, EMA, CDSCO, and 21 CFR Part 11.

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

How Do You Defend Pharmaceutical Mass Torts at Scale?

For high-stakes mass tort litigation, LezDo TechMed reviews, classifies, and prioritizes large claim volumes by the strength of the documented medical evidence, and flags documentation gaps and potential alternative causes for the attorney's and medical expert's review. CaseDrive plus trained reviewers scale from a handful of claims to thousands without slowing turnaround, delivering medical chronologies, narrative summaries, and pattern analysis across the docket.

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Case Strength Assessment

With expert record reviews, we flag documentation gaps and potential alternative causes for the attorney's and medical expert's review.

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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

Secure submission
01

Secure Submission

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

AI extraction
02

AI Extraction

AE data, timelines, and clinical gaps extracted in minutes

Expert medical review
03

Expert Medical Review

Medical professionals validate accuracy before delivery

Report formatting
04

Report Formatting

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

Delivery with audit trail
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

High scalability

High Scalability

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

Free pilot program

Free Pilot Program

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

End-to-end services

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.

Seamless case management

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.

Human plus technology advantage

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

FDA & EMA

Built to help you meet regulatory deadlines

More Focus

On signal detection tasks

Read Full Case Study

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.

Standard 24 to 48 hours (company-level average); 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.

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.

LezDo TechMed pharmaceutical data analysis reviewer headshot

Clinically reviewed by

Janu Padmaprasad, RN, BSN, CLNC

· Last reviewed August 14, 2026