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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
SAMPLE OF PAST CLIENTS
RECENT PROJECTS
Allergic Patients
Pfizer approached our statistical consulting team with a critical question: Is there a significant effect of allergies on treatment responses? Pfizer was committed to ensuring the effectiveness of their products and needed to investigate this matter thoroughly. We undertook a meticulous data analysis to address the research question and evaluate the hypothesis. The foundation of […]
Compound D-600
Roche embarked on a research endeavor to investigate the effect of compound D-600 on gluconeogenesis, which is a crucial metabolic process that affects human health. Roche recognized the significance of this relationship in advancing medical knowledge and drug development and sought statistical consulting to conduct a comprehensive survey-based study. The foundation of this research project […]
Bending Stiffness
Johnson & Johnson entrusted our team with conducting a research initiative to explore the variations in bending stiffness and strength based on fiber diameter. The objective was to understand the relationships between these critical properties and fiber diameter, paramount for developing and optimizing pharmaceutical products. The foundation of this research project was a massive dataset […]