Our Approach
Poor data quality is one of the most common — and most preventable — reasons clinical trials fail at the regulatory submission stage. Incomplete records, uncleaned queries, inconsistent coding, and inadequate validation all add up to delays, rejections, and costs that no sponsor wants to face after years of investment.
At Althian, we build data quality into the study from day one — starting with the database design and ending with a locked, analysis-ready dataset that meets the expectations of COFEPRIS and international regulatory agencies.
What We Do
We design and build study databases using industry-standard EDC platforms, tailored to your protocol's data collection requirements. Our team works with sponsor-preferred systems and ensures the database is validated, user-tested, and ready before the first patient is enrolled.
We implement rigorous edit checks and validation rules to catch data discrepancies at entry. Our data management team reviews, queries, and resolves data issues continuously throughout the study — so problems are fixed in real time, not discovered at database lock.
Our biostatistics team develops the statistical analysis plan, performs all required analyses, and generates tables, listings, and figures (TLFs) for inclusion in your clinical study report. All statistical work is performed in compliance with ICH E9 guidelines and sponsor requirements.
We manage the full database lock process — final data review, query resolution, quality control checks, and formal lock documentation — delivering a clean, auditable dataset ready for statistical analysis and regulatory submission.
At Althian, data management is not a back-office function — it is a core part of how we run every study.
We integrate seamlessly with your existing infrastructure, work with your preferred EDC platform, and deliver analysis-ready data that meets the expectations of COFEPRIS and international regulatory agencies.
Monterrey, México