Ensuring your clinical trial is submission-ready
At Phastar, we have a team of specialist biostatistical programmers with a wealth of experience and expertise. We can support across the entire lifecycle of your trial, from protocol development, through to regulatory submission.
With a deep understanding of regulatory requirements and industry best practices, we guarantee the highest quality standards in every line of code, every statistical analysis, and every deliverable. Whether you’re submitting to the FDA, EMA, PMDA or NMPA, we can help you build submission-ready regulatory packages.
We work seamlessly with your team, ensuring that our solutions align with your project goals and timelines. Our proactive communication and collaborative approach make us more than just a service provider – we become an extension of your team.
CDISC-compliance is fundamental to everything. We have vast experience in creating CDISC-compliant SDTM and ADAM datasets, and the necessary supportive documentation including SDTM annotated CRFs, Define.XML and Reviewer’s Guides.
Our proprietary tools, REPIT and MAPIT, provide automation for many of the processes related to TFL and SDTM. Designed and engineered by our Operational Excellence team, they provide reproducibility, scalability and consistency whilst ensuring the highest level of reporting quality for your study.
We’re proud to say that we’ve never had a trial rescued. In fact, our reputation and service level mean we’re a go-to for trial rescues. If you’ve reached an impasse with your study progress, or you’re dissatisfied with your current provider, we can help turn things around.
Phases I–IV and Integrated Summary of Safety/Efficacy (ISS/ISE)
Developing analysis datasets and tables, listings and figures
SAS and R programming
Bioresearch
Monitoring (BIMO)
requirements
Health Technology
Assessment (HTA) and Real World Evidence (RWE) projects
Participating in
Data Monitoring
Committees (DMC)
The industry standard quality control check process involves two stages of review. We go beyond, with a third stage, performed by an independent expert. Ensuring your programmed deliverables are the highest quality. Every single process is underpinned by our Phastar Discipline framework, ensuring error-free results that you and your stakeholders can trust.
By choosing Phastar, you not only gain access to our expert team of programmers, but also our world leading statisticians. We collaborate and draw expertise from across the organization to accelerate your trial development and drug approval. And we can work in a way that’s bespoke to your needs, whether that’s a standalone project or a team of experts embedded directly into your organization.