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. Therefore, they can perform any statistical test.
• 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 biometrics CRO experts have PhDs in statistics from leading universities—such as Harvard, Stanford, and Columbia. Additionally, they include nationally renowned experts. Therefore, they have extensive backgrounds in biostatistics.

Biometrics CRO Services – Statistical Services 

• Statistical input into study design and 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 on-going clinical trials (interim analyses, sequential trial monitoring)
• Independent data monitoring committees
• Setting up randomization schemes
• Multiplicity (optimally evaluate more than one outcome in a trial)
• Regulatory advice
• Observational and epidemiological studies
• Interpretation of results
• Data visualization
• Statistical training
• CDISC and ADaM submission-ready dataset development and quality control for submission compliance
• Analysis of dataset development and quality control
• Analysis of 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,  safety committee, and endpoint committee support

Biometrics CRO Services – Data Management  

• Cross-functional biometrics team plans
• EDC, including accredited Medidata Rave support
• Risk-based monitoring
• IWRS
• CDASH standard datasets
• Consulting (strategic program planning, protocol review, EDC selection, etc.)
• Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
• Database design, development, and maintenance
• Medical coding using WHODrug & MedDRA dictionaries
• Data validation programming and testing, inclusive of edit check and manual review specifications
• Data cleaning and query management
• 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
• Extensive edit checking
• Database transfer
• 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 – 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 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