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Email: info@amstatisticalconsulting.com
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Visit Us: 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301
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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