Data & Medical Writing
Smart beginnings. Solid outcomes.
We believe data is only valuable when it tells the right story. At UNIQ, our data management, biostatistics, and medical writing teams work together to transform raw datasets into regulatory-ready insights.
Data & Medical Writing
Smart beginnings. Solid outcomes.
We believe data is only valuable when it tells the right story. At UNIQ, our data management, biostatistics, and medical writing teams work together to transform raw datasets into regulatory-ready insights.
Data Management & Biostatistics
Insights that drive outcomes.
- We deliver EDC setup, validation, and real-time analytics using leading platforms and custom UNIQ's dashboards. Our biostatistics experts design adaptive, efficient analyses that accelerate decision-making — from interim looks to final submission datasets.
- Built-in quality controls and automation mean cleaner data, faster.
One Project
One Integrated Team.
- At UNIQ Trials, our Data Management and Biostatistics teams work as a single, seamless unit — aligned, responsive, and deeply experienced. Every study we support is managed with precision, speed, and scientific discipline, no matter how complex the timelines or datasets become.
- Our approach is simple: One project. One accountable team. Zero compromises on quality.
Performance You Can Count On.
- 98% of all Data Management KPIs consistently achieved across sponsors
- 99% of Biostatistics milestones delivered in full
- Proven track record across fast-moving biotech, rare disease, and oncology programs
Global Expertise, Locally Engaged.
- Our data and statistics specialists are located across Europe and the United States, allowing us to support your study in the time zone and region that best fits your operational model. With UNIQ, you get a team that functions as an extension of yours — proactive, reliable, and committed to delivering clean, trusted data from first patient into CSR.
Shaping Technology Around Your Study - Not the Other Way Around
Flexible, adaptive platforms engineered for the realities of modern clinical research.
- At UNIQ, we only work with electronic data capture (EDC) systems that can, flex, scale, and evolve with your study requirements. Every sponsor and every protocol is. different - which is why our technology stack is built around configurability, accuracy. and seamless integration.
- We combine the world's Leading EDC platforms with our own ecosystem of digital tools to ensure faster builds, cleaner data, and frictionless collaboration across teams, sites, and vendors.
Our Preferred EDC Platforms
Medical Writing for Clinical Trials
Clear. Compliant. Scientifically precise.
At unIQ Trials, our medical writing team supports every stage of your study — from first protocol concept to final regulatory submission.
Our writers are specialists in transforming complex data into accurate, persuasive, and regulator-ready documents. Whether your objective is approval, transparency, or scientific communication, we deliver documentation that is clear, consistent, and fully aligned with global requirements.
Our team produces a full suite of clinical and regulatory documents, including:
Clinical & Study Documentation
- Clinical development plans
- Clinical study protocols
- Clinical study reports (CSRs)
- Investigator brochures
- Lay summaries
Regulatory Submissions
- Clinical Trial Dossiers (CTD clinical overviews)
- Investigational Medicinal Product (IMP) dossiers
- Investigational New Drug (IND) dossiers
- Integrated summaries of safety and efficacy (ISS/ISE)
- Aggregated safety reports
- Clinical evaluation reports
Transparency & Data Disclosure
- Posting of clinical trial results (EudraCT, ClinicalTrials.gov)
- Data anonymization and disclosure support
- Medical review data
- Briefing documents for regulatory interactions
Why Choose unIQ Trials for Medical Writing Excellence
Proven Results. Trusted by Global Sponsors.
- Our medical writing team delivers documents that are not only scientifically sound — but submission-ready. We ensure clarity, accuracy, and regulatory alignment from protocol development to manuscript publication. Sponsors trust us because our documents stand up to ethics committees, regulatory agencies, and peer-reviewed journals worldwide.
- 8+ dedicated medical writers worldwide with an exceptional >90% retention rate
- 98% approval rate for study protocols by ethics committees and regulatory authorities
- 99% acceptance rate for scientific abstracts, posters, and oral presentations
- 95% of manuscripts successfully published in peer-reviewed journals
- 80+ congress presentations delivered annually
- 1,000+ clinical and regulatory documents produced over the past five years across 15+ therapeutic areas