AMSTAT Consulting: 19 Years of National Recognition in Biometrics Services


Our clients cite the following reasons for choosing our biometrics CRO services:

  • We have PhDs in statistics from leading universities, such as Harvard, Stanford, and Columbia.
  • We include renowned scholars and talented professors with extensive backgrounds in statistics and biostatistics.
  • We have over 100 years of technical experience. Additionally, we are experts in statistical analysis (e.g., t-test, ANOVA, ANCOVA, traditional regression, logistic regression, MANOVA, MANCOVA, factor analysis, cluster analysis, survival analysis, time series analysis, correlation analysis, meta-analysis, and more advanced statistical techniques such as structural equation modeling (SEM), hierarchical linear modeling (HLM), and path analysis).
  • Our analysts use various software packages, including SPSS, SAS, Stata, HLM, Mplus, R, SPSS Amos, SPSS Modeler, Azure, JMP, Python, WinBUGS, Minitab, SYSTAT, LISREL, EQS, Smart PLS, WarpPLS, EViews, and many others.
  • Our biostatistical consultants use the latest statistical software available today. In addition, they can apply the required technical and specialized techniques and procedures of statistics. Thus, we are confident you will be satisfied with our biostatistical consultants.
  • We are more reasonably priced than most other firms. Thus, our fees are pale compared to the savings our help generates for our clients.
  • We offer friendly support and ultra-fast turnaround times.
  • Over 90% of clients request our assistance more than once, as they are almost universally happy with our different brands.
  • We possess good communication skills. Therefore, we can interact with our clients fluently and comfortably.
  • We are members in good standing of the Statistical Consulting section of the American Statistical Association.
  • We are committed to quality and excellence, reflected in our record of five-star reviews.
  • Our diverse team of scientists brings a wealth of knowledge spanning pharmacology, physiology, therapeutics, and acute and chronic diseases, contributing to a comprehensive understanding of clinical research.
  • As a CDISC member, we prioritize compliance and can deliver SDTM and ADaM packages tailored for regulatory submissions across various therapeutic areas.




Are you looking for expert assistance to maximize the accuracy of your research? Our team of experienced statisticians can help. We offer comprehensive assessments of your data, methodology, and survey design to ensure optimal accuracy so you can trust us to help you make the most out of your research.


Expert Guidance: Our team brings years of experience in statistical analysis to help you navigate the complexities of your research.

Tailored to Your Needs: Whether you are fine-tuning your methodology or seeking clarity on your data, we offer personalized advice to improve your outcomes.

Build on a Foundation of Trust: Join the numerous clients who’ve transformed their projects with our insights— ’The evaluation was a game-changer for my research!’


Take advantage of this exclusive offer to take the first step towards refining your research with expert guidance. Contact us now to secure your spot.


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Phone Support: +1 (650) 460-7431


24/7 Chat Support: Immediate assistance via our chat icon in the right corner of our website

Visit Us: 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301

Your confidentiality is our priority. Non-disclosure agreements are available upon request.

Biometrics CRO Services - Statistical Services 

  • Statistical input into study design & protocol development
  • Adaptive study designs
  • Sample size calculations
  • Analysis plans
  • Optimizing study success
  • Identifying the primary endpoint
  • Modeling and simulation
  • Prediction of drug exposure
  • Optimal evaluation of information for ongoing clinical trials
  • Independent data monitoring committees
  • Setting up randomisation schemes
  • Multiplicity (optimally evaluate more than one outcome in a trial)
  • Regulatory advice
  • Observational and epidemiological studies
  • Interpretation of results
  • Data visualization
  • Statistical training

Biometrics CRO Services - Data Management  

  • Cross-functional biometrics team plans
  • EDC, including accredited Medidata Rave support
  • Paper CRF and hybrid options
  • Risk-based monitoring
  • IWRS
  • CDASH standard datasets
  • Database build and validation
  • Data entry
  • Extensive edit checking
  • Clinical Team and Site training, mentoring, and support with EDC
  • Site metrics for CRF completion and Query Resolution
  • Continual Quality Control review, including audit trail logging
  • MedDRA and WHODrug coding
  • AMP, cell therapy studies, Observational, Device and Marketing studies
  • 3rd party vendor oversight and data transfer planning

Biometrics CRO Services - Data Science 

  • Development of bespoke visualizations to support data interpretation and monitoring
  • Algorithm development and the use of machine learning to support precision medicine, e.g., predictive biomarkers
  • Maximizing the value of patient-generated data such as wearables and biosensors.
  • Application of machine learning and artificial intelligence techniques to maximize the value of clinical data and its metadata
  • Identification of data sources and associated analytics to answer critical questions
  • Development of data visualizations enabling teams to explore data independently
  • Analysis of historical and operational data, providing data insights and driving benefit
  • Integration & analysis of clinical data alongside Electronic Healthcare Records (EHRs), Real World Data (RWD) and other omics datasets

Biometrics CRO Services - Medical Writing 

Document Management for Protocols

  • Protocols & Amendments: Assistance from synopses to complete protocols and their crucial amendments.
  • Consent Forms to Reports: Comprehensive assistance with informed consent forms, safety narratives, clinical study reports, and more.
  • Regulatory Compliance Documents: Assistance with Patient information leaflets and annual safety reports.

Expertise in Regulatory Submission

  • Submission Documents: Specializing in IND, CTA, NDA/sNDA, MAA, NDS, and jNDA.
  • Comprehensive Summaries: Preparation of clinical and non-clinical summaries (Module 2) and integrated summaries of efficacy and safety (Module 5).
  • Reviewer Responses: Expert drafting of responses to agency reviewers, ensuring clarity and compliance.

Regulatory Meetings & Risk Management

  • Regulatory Briefings: Assistance with tailored documents for pre-IND, end of Phase 1/2/3, pre-NDA meetings, and more.
  • Risk Management Plans: Development of plans to mitigate risks, ensuring your submissions are comprehensive and compliant.

Biometrics CRO Services - Functional Service Provision

  • Experienced Data Specialists
  • Vital Role in Biopharma Research
  • Growing Demand for Specialist Expertise
  • Global Clinical Data Solution
  • Expert Teams for Clinical Programs




Allergic Patients

By AM | May 26, 2024

Pfizer approached our statistical consulting team with a critical question: Are allergies significantly affecting treatment responses? Pfizer was committed to ensuring the effectiveness of their products and needed to investigate this matter thoroughly. We undertook a meticulous data analysis to address the research question and evaluate the hypothesis. We determined the sample size using a […]

independent-samples t-test

Compound D-600

By AM | May 26, 2024

Roche embarked on a research endeavor to investigate the effect of compound D-600 on gluconeogenesis, which is a crucial metabolic process that affects human health. Roche recognized the significance of this relationship in advancing medical knowledge and drug development and sought statistical consulting to conduct a comprehensive survey-based study. We determined the sample size using […]

Paired-Samples T-Test

Bending Stiffness

By AM | May 26, 2024

Johnson & Johnson entrusted our team with conducting a research initiative to explore variations in bending stiffness and strength based on fiber diameter. The objective was to understand the relationships between these critical properties and fiber diameter, which is paramount for developing and optimizing pharmaceutical products. We determined the sample size using a robust power […]

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