In clinical reporting, it’s not the complexity that breaks things - it’s the lack of adaptability.

At EBERS Solutions, we work with pharma teams to build reporting models that are lean, flexible, and designed for real use — not just delivery.
Every collaboration helps us refine the system. That’s how we reduce cost, effort, and turnaround time – without cutting corners.

Our Solutions: Designed Around Real Pharma Needs

Our model isn’t just about delivering outputs — it’s about embedding flexibility, efficiency, and collaboration into the processes pharma teams rely on every day.

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 DSUR Safety Outputs

Exposure-adjusted incidence tables, cumulative listings, and safety summaries — tailored for DSUR requirements with fast adaptability to MedDRA versions and data cuts.

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IB Statistical Outputs

AE/SAE summaries and exposure tables — streamlined for Investigator’s Brochures with flexible integration across protocols and consistent formatting.

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Interim Review Packages

Optimized delivery of blinded and unblinded TLFs — enabling fast reruns, protocol flexibility, and timely DSMB or internal data reviews with minimal manual effort.

AE Narrative Automation

AE Narrative Automation

Template-based narrative generation using safety datasets and MedDRA coding — optimized to reduce writing workload and support high-volume safety reporting with consistency.

Regulatory Query Support

Regulatory Query Support

Targeted outputs like patient profiles, safety listings, and subgroup summaries — built for rapid turnaround, audit readiness, and high-stakes regulatory interactions.

IEMT / Internal Safety Monitoring Support

IEMT / Internal Safety Monitoring Support

Cumulative safety summaries and benefit–risk views across studies — supporting internal reviews and signal detection before formal submissions. Tailored for flexibility and rapid iteration in multi-study portfolios.Tailored cumulative AE/SAE summaries, exposure tables, and safety snapshots — built to support internal safety reviews, benefit-risk assessments, and cross-study insights before formal submission phases.

 Custom Review Support

Custom Review Support

Custom listings and visual summaries built around sponsor-specific questions — designed to support internal reviews, trend exploration, and real-time insights during ongoing trial phases.

 Patient Data Listings (PDs)

Patient Data Listings (PDs)

Subject-level listings that present detailed safety and efficacy data per patient — designed for medical review, signal detection, and submission support. Easily customized by domain, filter, or protocol-specific needs.

 Protocol Deviation Listings

Protocol Deviation Listings

Focused summaries of protocol violations by patient and category — structured to support deviation trend analysis, CSR inclusion, and audit readiness.

Blinded/Unblinded TLF Delivery

Blinded/Unblinded TLF Delivery

Tailored output generation for both blinded and unblinded states — enabling compliant, efficient analysis for DSMBs, interim reviews, or final database lock with clear version control.

External Vendor Delivery Checks

External Vendor Delivery Checks

Independent verification of third-party deliverables — including safety tables, listings, and reports — to ensure accuracy, consistency, and alignment with sponsor expectations before regulatory submission or internal use.

Intelligent Process Automation

In today’s fast-paced pharmaceutical industry and clinical trials landscape, efficiency, accuracy, and real-time insights are critical. Our expertise in Data Management, Statistical Programming, and Biostatistics allows us to develop tailored automation solutions that streamline workflows, enhance data integrity, and accelerate decision-making.

 

Transforming Processes with Automation
We specialize in designing and implementing intelligent automation that optimizes complex processes, ensuring consistency, precision, and efficiency across clinical studies. Our solutions are built to adapt to specific client needs, integrating seamlessly into existing workflows to maximize productivity.

 

Automated Listing Generation Across Studies
One of our key automation solutions enables seamless medical listing generation throughout a clinical trial. This process offers:

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Effortless Setup for Each Study – A streamlined configuration process ensures quick implementation, enabling teams to define and customize the listings they need.
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Dynamic Medical Listings – Automated generation of essential study-specific listings, including Adverse Events, Demographics, Laboratory Data, ECG Readings, and Custom Listings.
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Comparative Data Insights – Real-time comparison between different data cuts, allowing medical and data management teams to track changes, identify trends, and monitor critical data points throughout the study.
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Enhanced Data Integrity & Monitoring – Immediate visibility into data discrepancies, ensuring timely updates and accurate clinical trial tracking.

Our automation solutions minimize manual effort, reduce errors, and enhance data-driven decision-making, allowing teams to focus on critical insights rather than repetitive tasks.

Why Choose Our Intelligent Automation?

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Industry Expertise – Deep knowledge of pharmaceutical industry processes, clinical trial data management, and statistical programming.
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Custom-Built Solutions – Tailored automation strategies designed to meet specific client and study requirements.
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Efficiency & Compliance – Enhancing productivity while ensuring regulatory compliance and data accuracy.
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Scalability & Adaptability – Solutions that evolve with study needs, accommodating changes without disrupting workflows.
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