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Phone Support: +1 (650) 460-7431
Email: info@amstatisticalconsulting.com
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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
SAMPLE OF PAST CLIENTS
RECENT PROJECTS
Painkillers & Chronic Pain
Novartis engaged our team to conduct a comprehensive survey-based study investigating the effect of painkillers on chronic pain management. The study’s objective was to provide healthcare providers and patients with valuable insights into the effectiveness of pain medications in managing this challenging condition. We built the research project on a substantial dataset of 11,000 patient […]
Snore Fix
SnoreRx had set out to scientifically evaluate their product’s effectiveness in reducing snoring – Snore Fix, a snore-relieving throat spray. The company recognized snoring as a common sleep-related issue, which often becomes a cause of concern for individuals and their sleep partners. To undertake this research initiative, SnoreRx approached us, seeking our expertise in conducting […]
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