Software
SmartSTATS suite
Enoval
Validate your analytical procedures and bioassays with confidence, from development to routine, from one lab to another.
Analytical Procedure Validation
Prove that your physico-chemical procedures measures what it should, with the accuracy and precision required for reliable release and stability testing.
Automated validation reporting for physico-chemical procedures (HPLC, GC, UV, ICP, AAS, titration). Computes accuracy, precision, and Total Analytical Error profiles using β-expectation tolerance intervals. Generates submission-ready reports aligned with ICH Q2(R2), ICH Q14, ICH M10, and USP <1210>. Optimized experimental design within the QbD framework.
Bioassay Validation
Demonstrate that your biological assay delivers trustworthy potency results, whether you run an ELISA, a cell-based assay, or a qPCR.
Qualification and validation of biological assays: ELISA, RIA, qPCR, cell-based, microbiological, parallel-line, parallel-curve, and slope-ratio formats. Dedicated potency module for relative potency assays following a lognormal distribution. Reports aligned with USP <1032>, <1033>, and <1034>. Equivalence testing for parallelism and similarity.
Procedure Transfer
Before you transfer a procedure to another lab, know the risk that routine results will fall out of specification, and act on it.
Tolerance interval-based assessment of procedure transfer feasibility between sender and receiver laboratories. Quantifies the risk of future out-of-specification results at the receiving site under routine conditions. Supports all four USP <1224> transfer approaches. Automated protocol and report generation.
Stabelity
Long-term and accelerated stability analysis with Arrhenius kinetic modeling and goodness-of-fit diagnostics. Shelf-life estimation, internal release limit computation, and out-of-trend detection. Supports bracketing and matrixing designs. Submission-ready reports aligned with ICH Q1E and the forthcoming consolidated ICH Q1.
SmartSTATS Returns Home
to arlenda
PharmaLex Beglium has transferred ownership of the SmartSTATS suite, Enoval and Stabelity, to Arlenda. For our clients, this is good news: the software has moved back to the team that knows it best, at exactly the moment the industry needs it most.
Our roots
arlenda was founded in 2003 by Dr. Bruno Boulanger, whose work has directly shaped the statistical principles now embedded in ICH Q2(R2) and USP <1033>. He is joined by Cédric Dubourg, who has maintained and evolved SmartSTATS since 2010, and Nils Boulanger, AI engineer, who brings the next generation of data science to the suite. Continuity, expertise, and innovation - under one roof.
The timing matters
Digitalization and AI are reshaping how analytical and biopharmaceutical work gets done, while regulatory expectations have never been more demanding. Our clients need a partner who understands both sides of that equation, responds quickly, and stays close to their reality.
Values
The People Behind Arlenda
Bruno Boulanger
CEO
Description
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Bruno is a recognized leader in applied statistics with over 30 years of experience across pharmaceutical and medical device development. He has held senior roles at Eli Lilly and UCB, founded Arlenda in 2003, published over 100 scientific papers, and launched the BAYES conference series.
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Gaëlle Martin
Head of QA
Description
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20+ years in QA leadership. QMS aligned with GMP, GCP, GAMP5, ISO 9001/13485. Computerized system validation and complex GxP projects.
Cédric Dubourg
Head of Software
Description
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Cédric is the lead developer behind Arlenda's SmartSTATS platform, with nearly two decades of experience across banking, insurance, and pharmaceutical services. He has built and maintained the platform since 2010, covering Java development, web technologies, cloud infrastructure, containerization, database management, and Linux administration. He has kept SmartSTATS running, secure, and evolving for the past fifteen years.
Nils Boulanger
CTO
Description
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Nils Boulanger is CTO of Arlenda, where he leads AI development and the technical architecture behind the SmartSTATS platform. With a Master's in Data Science Engineering, he builds AI solutions on a foundation of software engineering and applied statistics, designing secure, scalable systems for regulated environments.