Precision. Compliance. Trusted Delivery.

Lambros Analytics is a specialized clinical analytics partner dedicated to advancing healthcare innovation through high-quality biostatistics, statistical programming, and regulatory-compliant data solutions for Sponsors and Contract Research Organizations (CROs) in the pharmaceutical and biopharmaceutical industries.

Headquartered in Bengaluru, India, and incorporated as an MCA-registered private limited company, we combine deep domain expertise with disciplined execution to support clients across the full clinical development lifecycle — from early-stage biomedical research to global regulatory submissions.

Our comprehensive capabilities include:

Advanced biostatistical analysis for in-vitro (dissolution profiles, IVRT/IVPT, population bioequivalence using similarity factors, bootstrap techniques, and multivariate methods) and in-vivo studies (toxicology, stability/shelf-life prediction, PK/PD modeling).

End-to-end statistical programming in SAS and R, including randomization schedule generation for BA/BE and clinical trials (IVRS integration), TLF development/validation, and analysis dataset creation.

Full CDISC compliance support (SEND, SDTM, ADaM dataset mapping, validation, and Pinnacle 21 checks) to ensure submission-ready deliverables for major regulatory authorities, including USFDA, EMA, Health Canada, MHRA, TGA, DCGI, ANVISA, and PMDA.

Expert statistical planning: sample size estimation with literature-based justification, development/review of Statistical Analysis Plans (SAP), TLF mock shells, and query responses for statistical sections in regulatory interactions.

Flexible engagement models (full-service, FSP/source resourcing) tailored to accelerate timelines, mitigate risks, and deliver precise, compliant, and reliable insights.

we are committed to intelligent, data-driven decision-making that empowers our partners to bring innovative therapies to patients faster and with greater confidence.

Lambros Analytics

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Lambros Analytics

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