About us
Who We Are
- We are a team of statisticians and data scientists providing data management, biostatistics and programming services to pharma and MedTech companies.
- We are based in the SF bay area and have been in business since 2013 with close ties to Stanford biostatistics program. We have supported numerous clinical trials for NDA, BLA, and PMA submissions from trial design to programming.
- With unique experiences in the integrated design and analysis of clinical trial and RWE studies, we also 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
- We are always open to technologies that can improve our work and deliver more values to our customers. We are gladly announcing our partnership with SageMed AI Inc to bring AI capacities to our workflow that will allow delivery of the same quality services faster at lower costs.
Our Experiences
For more than 15 years, we have worked in a range of therapeutic areas including diabetes and cardiovascular disease, oncology, orphan disease, CNS 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. We have supported more than 10 pivotal trials and submissions and authored more than 50 publications.
Services
Clinical Trial Biometrics Support
- Study design and power calculation: Phase II - IV study design and strategy consultation, group sequential design, Bayesian adaptive design, trial/RWE hybrid study design.
- Biostatistics support: development of protocol, SAP, TFL, ISS/ISE and regulatory documents.
- Statistical programming: 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
- Supported pivotal trials and regulatory submissions for more than 10 products such as Vimizim, Palynziq, Byetta, Tecentriq, Camzyos, Zepbound, ThermolCool SmartTouch catheter, Da Vinci robotic surgery system etc.
- Authored more than 50 peer reviewed medical publications
- Featured research project by American Academy of Ophthalmology.
- Proudly sponsored and supported more than 10 academic research and training projects.
- 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
Spark Therapeutics
Jasper Therapeutics
bioMerieux
Intuitive Surgical
Medtronics
Stanford Medical School
University of Pittsburg Medical School
Michigan State University Medical Schcool
Rutgers Medical School