About us
Who We Are
- We are a team of statisticians and data scientists with unique experiences in the integrated design and analysis of clinical trial and RWE studies for drug development based in San Francisco bay area.
- We provide data solutions to the emerging field of utilizing EHR data to support clinical development programs and tackle challenging problems in the application of real-world data to support regulatory submissions:
- fit-for-purpose real-world data identification and evaluation
- verification and validation of EHR data
- automated extraction of charts data
- integrated clinical trial and RWE study design
Our Experiences
We have worked since 2013 in a range of therapeutic areas including diabetes and cardiovascular disease, oncology, orphan disease, and medical devices. Our clients include major pharmaceutical companies such as Roche, Eli Lily, Gilead, Johnson & Johnson, Biomarin, AstraZeneca, Novartis, Amgen, and Genetech as well as academic institutions and governmental agencies.
Services
Clinical Trial Biometrics Support
- Study design and power calculation: Phase II - IV study design consultation, group sequential design, Bayesian adaptive design, trial/RWE hybrid study design.
- Biostatistics support: development of protocol, SAP, TFL, ISS/ISE and regulatory documents.
- Programming support: SAS, R, SQL, Python
- Publication and medical affairs: support in biostatistics, programming, and writing for abstracts, posters, and manuscripts.
Real World Evidence Study Support
- Database recommendation: consultation on fit-for-purpose use of the on-market databases for clinical development.
- Real-world data management:
- data quality assessment, verification, and validation
- chart extraction for chart review study
- data standardization (OMOP)
- data transformation to CDISK compliant datasets.
- RWE study design:
- integrated trial/RWE studies such as external controls studies.
- chart review study design
- comparative effectiveness study design
- HEOR study
- causal inference
- Data Analytics: real-world data analysis using causal inference techniques.
- Regulatory Submission: support for regulatory submission of RWD and RWE.
- Publication support
- Linked EHR and genomics data
Achievements
- PrecisionFDA Challenge Top Performer: Making Sense of EHR Race/Ethnicity Data (https://precision.fda.gov/challenges/30), in collaboration with Regeneron.
Past Clients and Collaborators
Biomarin
J & J Inc
Astrazeneca Inc
Novartis
Genetech
Roche
Kite
Eli Lilly
Regeneron
Stanford Congenital Heart Failure Center