Biostatistics, statistical programming and data management for pharma and biotech sponsors, powered by AI-assisted quality control and a decade of delivery experience.
Inspection-ready outputs, every deliverable on schedule and teams that stay with your program. Trusted by pharma and biotech teams across the US, Europe and India for over a decade.
Statisticians and programmers who have seen it all.
Clear plans and no surprises at database lock.
Across phases, indications and submission types.
The same experts from first study to last.
Long-term partnerships with CROs and biotechs.
Audit-trail documentation built into every output.
Sigma-Chiconsulting provides comprehensive clinical expertise to meet the needs of its clients. Innovative methodologies and experienced teamwork maintain the highest quality, with on-time deliverables for every clinical study. This is our biggest strength.
For more than a decade, Sigma-Chi Consulting has partnered with pharmaceutical and biotech companies to deliver accurate, submission-ready clinical results. Our statisticians, programmers and data managers work as part of your team, combining deep CDISC expertise with AI-driven quality checks so your studies stay on schedule.
Review protocol & SAP and set timelines.
CRFs, SDTM & ADaM datasets to CDISC.
Double programming plus AI TLF QC.
TLFs, Define-XML & submission packages.
Agency queries, ad-hoc analyses, next study.
Clinical programming is a connected chain of specifications, datasets and outputs. Sigma-Chi supports every stage, and automates quality checks where it matters most.
Study data arrives from EDC systems, central labs, ePRO and other vendors, often in different formats and structures.
Raw variables are mapped to CDISC SDTM domains, with controlled terminology applied consistently across the study.
Programs convert the raw data into standard SDTM datasets that are ready for review and submission.
Analysis datasets are designed from the statistical analysis plan and table shells, with every derivation documented.
Analysis-ready datasets with derived variables, flags and full traceability back to SDTM.
Tables, listings and figures are produced for the clinical study report, DSMB reviews and regulatory submission.
End-to-end biometrics, from first patient in to final submission. Sigma-Chiconsulting offers a complete menu of biostatistical and programming services. Sponsor companies can choose the services that meet their needs, from assisting with protocol development to statistical analysis and reporting.
Study design, sample size, SAPs and statistical analysis you can defend to regulators.
Learn more →SDTM, ADaM, TLFs and Define-XML in SAS and R, independently validated.
Learn more →CRF design, DMP and DVP, data cleaning, reconciliation and database lock.
Learn more →Study planning, site support and trial oversight that keeps timelines on track.
Learn more →Submission-ready packages and responses for FDA, EMA and PMDA.
Learn more →Dedicated, scalable teams from our India hubs that plug into your SOPs.
Talk to us →Our intelligent validation engine reviews tables, listings and figures against your shells and ADaM data, catching issues that usually surface only in late-stage manual QC.
Our AI TLF QC tool automates repetitive TLF checks. Try a quick estimate.
Assuming 1 h manual QC per TLF and a 50% reduction
Indicative estimate based on our typical 40–60% reduction in QC effort. Actual results depend on your outputs, standards and processes.
Leading CROs and eClinical companies rely on Sigma-Chi teams to deliver inside their own processes, on time and without quality issues. Here is what we deliver for them.
Client names and references are available on request under NDA.
Our statisticians, programmers and clinical data experts work together across time zones to keep your studies moving.
Charlotte, USA
US Office · AmericasSigma Chi-Consulting, 1304 Colgher Street, Charlotte, NC 28227
Business enquiriesinfo@sigma-chiconsulting.com
HR, employees & careershr@sigma-chiconsulting.com
Leipzig, Germany
Europe Office · GermanySigma Chi-Consulting, Straße des 18. Oktober 34, W 75, 04103 Leipzig, Germany
Business enquiriesinfo@sigma-chiconsulting.com
HR, employees & careershr@sigma-chiconsulting.com
Visakhapatnam, India
Branch Office · India6-75/5, 3rd Floor, KR Heights, Srinivasa Nagar, Chandrampalem, Madhurawada, Behind Max Showroom, Visakhapatnam, Andhra Pradesh – 530048
Business enquiriesinfo@sigma-chiconsulting.com
HR, employees & careershr@sigma-chiconsulting.com
Hyderabad, India
Head Office · IndiaH No 02-083, Opposite CPR Colony, Common Lane, Quthbullapur Mandal, Hyderabad 500055
Business enquiriesinfo@sigma-chiconsulting.com
HR, employees & careershr@sigma-chiconsulting.com
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