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.
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.
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.
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.
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.
We assist you with medical data analysis reports that are audit-ready for data validation checks from FDA, EMA, CDSCO, and other regulatory bodies.
We assist you with aggregated data analysis to detect early safety signals and feed into robust Risk Management Plans (RMPs).
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.
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.
With expert record reviews, we flag documentation gaps and potential alternative causes for the attorney's and medical expert's review.
We classify the mass tort claims as per the strength of the medical evidence in the records.
Our medical chronologies and narrative summaries strengthen your evidence preparation.
With precise medical data analysis, we identify inconsistencies in class action arguments.
Upload case files via CaseDrive's encrypted, HIPAA-compliant portal
AE data, timelines, and clinical gaps extracted in minutes
Medical professionals validate accuracy before delivery
Structured to your required format: ICSR, chronology, or custom
Timestamped trail supporting 21 CFR Part 11 compliance
Strategic advantages that set us apart in pharmaceutical data analysis
From a single case to thousands of mass tort claims, our services can scale effortlessly to fit your estimates.
Our free pilot program helps you experience our process flow and understand how we support your business operations.
From medical data analysis for regulatory reporting to mass torts, we provide end-to-end clinical data analysis everything under one roof.
With us, you get the power of CaseDrive, our advanced case management tool where your cases are automated, organized, tracked, and delivered with precision.
We provide AI-assisted medical record reviews with expert human audit, delivering 99% accuracy in the final reports.
Our free pilot gives you one complete case review, delivered through the full CaseDrive workflow, at the same 48-hour turnaround.
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
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.
Looking for answers about medical record review services? Explore our FAQs.
Medical data analysis for pharma is the structured review and interpretation of patient records to support drug safety operations, regulatory compliance, and litigation defense. For PV teams, it turns raw adverse event data into audit-ready ICSR documentation. For mass tort teams, it converts high-volume case files into defensible clinical evidence. Without accurate, timely analysis, pharmaceutical companies risk missed safety signals, non-compliant submissions, and weakened litigation positions.
We provide end-to-end medical record review for pharmacovigilance operations and mass tort litigation, including adverse event detection, root cause analysis, medical chronologies, narrative summaries, and regulatory-ready reports for FDA, EMA, and CDSCO submissions.
We have standard APS summary templates. If you want us to work on your own templates or tailor a new one, you can easily do that. We will work according to your requirements.
We review, classify, and prioritize mass tort claims based on medical evidence strength, and flag documentation gaps and potential alternative causes for the attorney's and medical expert's review. Medical chronologies and narrative summaries are prepared to support evidence preparation and pattern analysis across large claim volumes.
All reports are produced through an AI-assisted, human-in-the-loop workflow: extraction via CaseDrive followed by validation from trained medical professionals. This delivers a verified 99.8% accuracy rate across all pharma case types.
Standard turnaround is 24 to 48 hours. For high-volume mass tort batches, turnaround is confirmed at submission. CaseDrive provides real-time case tracking throughout, eliminating status follow-ups.
Yes. Our team of 200+ credentialed medical and legal professionals, supported by CaseDrive's AI infrastructure, scales to any volume, from individual PV cases to thousands of simultaneous mass tort claims, without compromising turnaround or accuracy.
All records are processed under HIPAA-compliant workflows with a completed SOC 2 Type II attestation and ISO 27001 certification, using end-to-end encryption and role-based access controls. We execute Business Associate Agreements with all clients. Full compliance documentation is available at trust.lezdotechmed.com.
Adverse event detection is the review step that flags whether the records document a possible adverse reaction. Root cause analysis goes further: we organize and flag the documented factors the safety team needs to assess drug-relatedness, including co-morbidities, concurrent medications, and pre-existing conditions. LezDo TechMed does not determine causation or drug-relatedness. Your pharmacovigilance scientists and physicians make that determination from the organized evidence.
New clients can submit one case at no cost through our free pilot program, experiencing the full CaseDrive workflow, turnaround standard, and report format before any commitment. Register at CaseDrive Signup or contact sales@lezdotechmed.com to arrange your pilot.
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.