Our Biometrics CRO Experts’ Expertise

Biometrics CRO

Biometrics CRO experts at AMSTAT Consulting have become nationally recognized for providing biometrics consulting. Our successful clients cite these reasons for choosing to work with AMSTAT Consulting.

  • Our biometrics CRO experts can provide expert statistical solutions. In addition, we ensure accurate results in a timely fashion. For example, quality control is achieved for analyzing datasets via independent programming.
  • We implement all of the latest advances in data standards and industry requirements. In addition, we can offer you clean data.
  • Our programmers have extensive experience providing statistical consulting. For example, they have an average of 25 years of technical experience. Additionally, they 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 programmers 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 statisticians work closely with the entire project team. For example, they ensure that they can get your dataset ready for analysis. In addition, they apply scientific knowledge to support you.
  • Our principals have PhDs in statistics from leading universities—such as HarvardStanford, and Columbia. Additionally, they include nationally renowned experts. Therefore, they have extensive backgrounds in statistics and biostatistics.
Biometrics CRO

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
Biometrics CRO

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
statistical consulting

Biometrics CRO Services – Biostatistics 

  • Study design
  • Protocol development
  • Strategic statistical consulting
  • Sample size calculations
  • Endpoint development
  • Randomization schemes
  • Statistical analysis plans (SAP)
  • Adaptive Design clinical trial planning, simulation and implementation
  • Statistical tables, data listings, and figures for clinical study reports (CSRs)
  • eCRF design and review
  • Statistical analyses and reports
  • Pharmacokinetic and pharmacodynamic analyses
  • Regulatory Submissions – Regulatory guidance, planning, and meeting representation
  • Integrated safety and efficacy analyses (ISS/ISE/ISM)
  • Data Monitoring Committee (DMC) services
  • SDTM and ADaM dataset preparation (submission ready dataset packages)
Biometrics CRO

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

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
Biometrics CRO

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 

October 15th, 2021|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

October 14th, 2021|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

October 13th, 2021|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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