High-quality patient data is intrinsic to regulatory success, and must be properly managed to ensure integrity, compliance, and safety. To minimize risk and deliver on your objectives, there is no room for error. In this highly specialized area, we concentrate on flawless execution, from planning through operations. Working with our team, you can be confident that your day-to-day biometrics partners are highly qualified experts with a passion for their work. We prioritize data quality and efficiency, whether we’re consulting with you or delivering the entire statistical workflow.
Our biostatistics and statistical programming proficiency goes hand-in-hand with our deep knowledge of complex indications and therapeutic areas. With years of expertise designing and implementing Phase I-IV clinical trials, integrated analyses, patient registries, and regulatory submissions, our team effectively anticipates risks, prevents delays, avoids extra costs, allocates resources appropriately, and develops realistic timelines.
Our biostatistics and programming team is experienced in working within a variety of relationship models including full-service work with Allucent project management, standalone biostatistics and/or programming support with other vendors, consulting support, and dedicated resourcing models. We can act as your primary statistical team to design and execute your clinical study or provide as-needed support and oversight to your existing statistical team.
Embedded within our biostatistics team is a group of full-time statistical consultants who can assist you with in-depth support for any complex statistical needs. They become a part of your core team and help you ensure proper study design and planning. They are available to support you in any way when you are confronted with complicated situations and decisions.
All biostatistics and programming deliverables are flexible and customized toward meeting your needs. Our flexible approach for statistical and programming services is tailor-made for small to mid-sized companies. We have an experienced team, strong management oversight and involvement, a history of successful regulatory submissions, and a wide array of therapeutic experience across all study phases.