Delivering advanced data-based insights to support evidence-based decision-making
OUR TEAM’S EXPERTISE
We are members in good standing of the Statistical Consulting section of the American Statistical Association.
Our diverse team of scientists brings a wealth of knowledge spanning pharmacology, physiology, therapeutics, and acute and chronic diseases, contributing to a comprehensive understanding of clinical research.
As a CDISC member, we prioritize compliance and can deliver SDTM and ADaM packages tailored for regulatory submissions across various therapeutic areas.
Biometrics CRO - 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 - 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 - 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 - 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.
