Biostatistics and Statistical Programming
Whether it’s a small first-in-human exploration or an international clinical trial, our global Biostatistics and Clinical Programming team brings technical expertise and efficiencies to projects of all sizes, through all phases of clinical development and commercialization.
Accuracy when it counts –
which means always
Our standardized processes, validated technologies and well-trained staff prepare tables, figures and listing outputs in advance of database lock, enabling you to make swift internal decisions and communicate effectively with the public, partners and/or investors.
Our Data Standards and Governance team ensures results are accurate through a process of ongoing data reviews, double programming and senior staff reviews. Thorough QC steps deliver high quality with any study protocol.
Working with you side-by-side
Our Biostatistical Consulting Group provides high-level statistical consulting services for DMCs, regulatory agency meetings, trial designs, data analyses and interpretations of key findings.
This group of seasoned professionals routinely provides technical support for complex statistical methodologies, whether the focus is adaptive designs, handling of missing data, navigating regulatory guidance, or negotiating with global authorities. The team also includes our Oncology Center of Excellence in Biostatistics.
Keywords: flexible, collaborative, always-on
We are committed to the highest levels of customer service and to delivering rapid responses to the critical questions you and the regulatory authorities you interact with need answered.
You’ll be supported throughout your project by one of our Bioanalytical Principal Investigators. We’ll communicate with you frequently to understand your needs, and you’ll find us to be a flexible partner that, drawing upon our deep expertise, will be adaptable as your requirements change.
Analysis and reporting services to meet every need
Our analysis and reporting services for a variety of reporting events include:
- High-end statistical consulting
- Comprehensive statistical analysis plans (SAPs)
- Randomization schedules produced in accordance with Integrated Response Technology (IRT) requirements
- Submission-ready datasets and supporting metadata, consistent with industry standards and trends
- Blinded and unblinded (e.g., interim and DMC analyses) Tables, Listings and Figures (TLFs), stand-alone statistical reports
