Our Biometrics CRO Experts’ Expertise

Biometrics CRO

AMSTAT Consulting is a biometrics CRO with expertise in statistics.

Why do businesses turn to AMSTAT Consulting?

Team of PhDs 

Our principals have doctorates in statistics from HarvardStanfordColumbia, and MIT.

♦ Statistical solutions

We ensure accurate results in a timely fashion. In addition, quality control is achieved for analyzing datasets via independent programming.

♦ Experts in statistical analysis

Our programmers have an average of 25 years of technical experience. Additionally, we use various software packages.

♦ Data standards

We implement the latest advances in data standards and industry requirements. Additionally, our statisticians can offer you clean data.

♦ Scientific knowledge

Our statistical consultants work closely with the entire project team throughout the study. In addition, they apply scientific knowledge to support you.

♦ 100% success

Our five-star reviews and 100% success with 10,000 businesses speak for themselves for 17 years. In addition, we are members in good standing of the Statistical Consulting section of the American Statistical Association.

♦ Comprehensive support

Our teams offer personalized, comprehensive, friendly support during and after your consultation and ultra-fast turnaround times. Therefore, over 90% of clients request our assistance more than once, as they are almost universally happy with the different statistical consulting brands we offer.

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Biometrics CRO Services – Statistical Services 

  • Knowledgeable and customer-focused support for randomization
  • Statistical programming
  • Statistical analyses
  • Statistical reporting
  • CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance
  • Analysis Dataset Development and Quality Control
  • Analysis Dataset Development and Quality Control for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE))
  • Tables, Listings, and Figures Development and Quality Control
  • Tables, Listings, and Figures Development and Quality Control for ISS and ISE
  • Interim Analysis Support
  • Annual Clinical Trial Safety Updates
  • Data Monitoring Committee (DMC),  Safety Committee, and Endpoint Committee Support
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Biometrics CRO Services – Data Management  

  • Consulting (e.g., strategic program planning, protocol review, EDC selection)
  • Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
  • Database design, development, and maintenance
  • Data validation programming and testing, inclusive of edit check and manual review specifications
  • Data entry, if applicable
  • Data cleaning and query management
  • Medical coding using WHODrug & MedDRA dictionaries
  • Serious adverse event (SAE) reconciliation
  • Management and integration of local laboratory reference ranges with CRF data
  • Integration, verification and reconciliation of external electronic data
  • EDC selection and end-user training
  • Database lock and archival
  • Database transfer
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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
  • Maximizing the value of patient-generated data such as wearables and biosensors
  • Application of machine learning and artificial intelligence techniques to maximize the value from clinical data and its metadata
  • Identification of data sources and associated analytics to answer key questions
  • Development of data visualizations enabling teams to explore data
  • 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
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Biometrics CRO Services – Medical Writing 

Clinical Trial & Program Documentation

  • Protocol Synopsis, Protocols, and Amendments
  • Informed Consent Forms
  • Clinical Study Reports (CSRs)
  • Safety Narratives
  • Clinical Development Plans
  • Investigator Brochure and Patient Information Leaflets
  • Annual reports
    • Periodic safety update reports (PSURs)
    • Development safety update reports (DSURs)
    • Periodic benefit-risk evaluation reports (PBRERs)

Regulatory Submission Documents

  • Marketing Applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
  • Clinical & Non-Clinical Summaries (Module 2)
  • Integrated Summaries of Efficacy and Safety (Module 5)
  • Responses to Agency reviewers
  • Regulatory Briefing documents for Agency meetings, including:
    • Pre-IND, End of Phase 1,  End of Phase 2/3, Pre-NDA  and  Advisory Committee
  • Orphan Drug Designation Applications
  • Risk Management Plans
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Biometrics CRO Services – FSP

  • Offering a team of highly skilled medical writers, clinical data managers, programmers, and statisticians.
  • Partnering with clients to help them scale their teams when and as needed.
  • Providing customized support for all types of projects and programs.
  • Providing sponsors with access to dedicated resources to work across multiple programs.
  • Enabling companies to ensure a pool of highly qualified personnel available to work on their clinical trial project needs.

Examples of Our Biometrics CRO Experts’ Projects

  • statistical consulting

Relative Risk of Lung Cancer 

June 22nd, 2022|0 Comments

We compared the difference in relative risk (RR) of lung cancer between the intervention and control groups. The intervention group exhibited an increase in RR of lung cancer from pre to post (p < 0.05). [...]

  • statistical consulting

Bending Stiffness

June 20th, 2022|0 Comments

Our statisticians examined the differences in bending stiffness between 2.0 mm RP and 2.0 mm SP. We conducted ANOVA to test the hypothesis for this study, which confirmed a significant difference between 2.0 mm [...]

  • statistical consulting

Compound D-600

June 19th, 2022|0 Comments

A major pharmaceutical company requested statistical consulting to examine the effect of compound D-600 on gluconeogenesis. Thus, we did a regression analysis. In conclusion, compound D-600 significantly affected gluconeogenesis (β = 0.52, p < [...]

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