Data Services Tailored To Your Program
Just the best-in-class services you need, within your budget and timelines. We design our programs to match your regulatory requirements with absolutely no unnecessary “extras” or contentious change orders that push deadlines and bloat budgets.
When you’re introducing a new treatment or device to the world, data quality is paramount. Quartesian leverages a state-of-the-art statistical programming platform and data management technology to crunch large data sets quickly and accurately. We’re the experts in gathering, organizing, analyzing, and formatting clinical data for regulatory submission.
When filing a generic, minutes — even seconds — count. Quartesian provides the same quality branded pharma programs demand, but with an aggressive first-to-file record and generics-specific regulatory expertise. A CDISC Gold Member, Quartesian has handled thousands of CDISC datasets for generics at a fraction of the cost of competing solutions. Learn more about Quartesian solutions for generics.
Clinical Data Management Solutions
Quartesian uses a 21 CFR Part 11 compliant, user friendly data management system to handle both paper CRFs and EDC-based projects, as well as rescue studies. We’ll deploy a data capture system, build your study database, review and verify data, and provide it in a format ready for submission to regulatory authorities — with database lock always on or before deadline.
Statistical Programming and Biostatistics
Our experienced team of Statistical Programmers and Biostatisticians have created custom macros and best practices that form our flexible, fast, and proven statistical programming framework — while our strict adherence to SOPs, extensive review process, and full-time QA team ensure the final data is of the highest quality.
Quartesian provides the following services for clinical studies from Phase I-IV:
- Analysis datasets specifications development
- Creation of derived datasets
- Creation of tables, listings and figures (TFL)
- QA/QC/validation of datasets and TFL
- PK/PD parameter calculation
- Creation of ISS(SCS)/ISE(SCE) analysis databases
- Observational study analyses
- Data mapping
- CDISC services (SDTM, ADaM and Define.XML)
- Post-marketing data analyses and reporting
- eCTD submission support
- Patient profile listings and figures
- Patient summaries for narratives
- Regulatory queries support
- Sample size calculations
- Statistical sections of the protocol
- Randomization schema
- Statistical analysis plans
- PK and PK/PD analyses
- Analysis of cardiac safety data (data from pilot and thorough QTc studies)
Clinical Data Analytics
Our team of skilled data scientists leverages cutting-edge big data analytics, artificial intelligence, machine learning, and more for real-time, data-driven decisions about your trial — no more guesswork.
- Utilize Real World Evidence (RWE) for informed decisions leveraging data mining and data fusion of EHR/EMR and Retrospective Claims Databases (RCD)
- Leverage longitudinal data for predictive and prescriptive modeling
- Reporting tools and dashboards enable real-time, data driven decisions
- Artificial intelligence (AI), machine learning (ML) and natural language processing (NLP) methodologies allow for more accurate decision making
- Expertise in R, Python, Spark, AWS Spotfire and Tableau
When the same partner that collects, analyzes, and formats your data also handles the final documentation reporting on that same data, you ensure the highest levels of quality and continuity from start to finish. Our medical writing has passed FDA and European regulatory authority muster, and has been displayed in meetings and conferences across the globe.
- Protocol development
- Study design consultation
- PK/PD reports
- Clinical summary reports
- Abstracts, posters, and manuscripts
Best-in-class Data. Unbelievable Speed and Cost Efficiency. Choose Quartesian.
High quality clinical data services you need, delivered at breakneck speed. Email firstname.lastname@example.org or call 1.609.454.3312 to learn how our expert team of data scientists can give you Clinical Data Your Way — and an edge in the race to file.