A2-Ai Information

A2-Ai Mission Statement: A2-Ai is a premier full-service Clinical Pharmacology Consultancy Service Provider run by leaders who put science and patients first. We provide end-to-end technical solutions to our clients including 1) Clinical Pharmacology 2) Pharmacometrics and 3) AI solutions. We aim to be your partner in engaging early and moving your assets as quickly as possible, with high quality, towards your corporate goals. We tailor the resources needed to support your assets and guarantee industry-leading high-quality standards. Our leadership has many years of experience within the field with many successful submissions under their belt. Our skilled Subject Matter Experts (SME) can act as a member of your project teams and seamlessly support your programs. We support all phases of drug development: Our early phase approach is to support pre-IPO and early phase companies to move their assets from IND-enabling stage to Phase I and Phase II. This includes assessment of IND packages, First in Patient dose selection, dose escalation strategy, dose optimization, and support of EOP1 and EOP2 Type C meetings with the FDA or EMA. Our staff have experience across multiple therapeutic areas including oncology, Inflammation, Diabetes, CNS and virology to name a few. Based on our significant experience in oncology, it is one of our primary therapeutic areas. Pharmacometrics work including exploratory analysis in support of early-phase assets is one of A2-Ai's key areas of expertise. Our late-phase approach is to share our extensive experience in late-phase drug development with you, including many successful NDAs/BLAs. In our late-phase services, we provide Medical Writing services such as CSR writing, submissions document writing (SCP and SBS) including performing all necessary quantitative pharmacology (PmX) reports for the submission (POPPK, ER for safety, ER for efficacy, and ER for QT).