We work as an extension of your team, leveraging deep industry expertise, rigorous science, and tailored technology solutions to simplify regulatory execution and deliver cost-effective approvals with speed and clarity.
A2-Ai is the ideal partner to help navigate the complexities of clinical pharmacology. Consult with our experienced clinical pharmacologists to move your program forward.
Our innovative modeling and simulation approaches allow us to predict drug outcomes, assess dose/exposure-response, and expedite clinical trial design.
Our expert preclinical scientists will help you with developing your IND, designing your topline First in Human (FIH)/First in Patient (FIP) protocol and estimating the FIH dose.
Our customized technology tools and solutions can help identify potential drug interactions and adverse effects early on in development, allowing for adjustments to be made before costly clinical trials.
At A2-Ai, we commit to the success of our clients' programs as if they are our own. We engage early and move your assets as quickly as possible toward your corporate goals. For every project, our approach to finding solutions is always customized, personalized, and collaborative. We tailor the resources needed to support your assets and guarantee industry-leading quality standards.
Our early phase support includes assessment of IND packages, First in Patient dose selection, dose escalation strategy, and dose optimization support of EOP1 and EOP2 Type C meetings with the FDA or EMA. Our staff has experience across multiple therapeutic areas such as inflammation, diabetes, CNS and virology, with specific expertise in oncology.
Our approach is to share our extensive experience in late phase drug development with you, which includes many successful NDA/BLAs across our staff. For late phase projects, we perform all necessary quantitative pharmacometrics (PMx) analyses and prepare reports for your submission (Population PK, ER for safety, ER for efficacy, and ER for QT). We also provide medical writing services such as CSR writing and submissions document writing for SCP and SBS.
Our high-performance cloud computing platform is designed to accelerate analysis, enhance collaboration, and ensure compliance across your entire organization — from the bench to the boardroom.
PMx work is bursty and compute-intensive. A2-Ai Cloud lets you spin up high-core nodes for model fitting and simulation runs without waiting in a queue or over-provisioning infrastructure.
Provides confidence that teams are using compliant, reproducible analytics without executives needing to arbitrate tooling decisions.
Offloads scientific compute complexity while maintaining security, access control, and auditability.
Enables validated statistical analysis at scale without long queue times or manual environment setup.