Since 2003, Altasciences has been designing, conducting, analyzing, and reporting on first-in-human (FIH) studies. We have conducted over 40 studies in the last three years alone, on both small molecules and biologics, in the U.S. and Canada. We are accustomed to reviewing preclinical data to design safe and efficient studies. Our sites have extensive, effective processes to protect subject safety, and well developed systems to quickly compile the data needed to make the decisions for dose escalations and adaptive design changes in SAD or integrated SAD/MAD trials.

We routinely include proof-of-concept arms using models with healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Our processes and large participant database successfully match study requirements and facilitate rapid recruitment into FIH studies. Patient populations that we have recruited for FIH trials include dyslipidemias, obesity, T2DM, psoriasis, atopic dermatitis, and allergies. We have conducted FIH trials requiring as many as 18 cohorts with no recruitment delays following decisions to proceed to the next dose levels.

Our team of specialists provides high quality support for bioanalysis, and the full range of research services, including data management, statistics and medical writing. We work closely with you to meet your milestones, and ensure compliant, on time regulatory submissions for your drug candidates.

Compliant and reliable datasets for your nonclinical study data are critical for successful FDA submissions. To ensure you are SEND-ready, our SEND team can help guide you through the requirements and the challenges. Altasciences uses submit^TM software to create datasets, and Pinnacle 21 to ensure data integrity.