About Us
We help our clients to consistently and authoritatively communicate their safety story in scientific evaluations and public disclosures
TO PROVIDE for a scientific evaluation of accumulating program-level safety information throughout drug development, leveraging scientific expertise and medical judgment of the multidisciplinary safety management team
TO IMPROVE the overall quality of safety reporting and to comply with requirements for IND safety reports based on data in the aggregate
TO RESTORE a balance between open-ended discovery of potentially important context-dependent information and mathematical techniques for sorting the signal from the noise
Greg Ball, ASAP Expert
Greg has 36 years of strong leadership, managing people and projects; including 12 years as a traditional Statistician and 10 years as a Safety Statistician. He served in the Navy and taught high school math and physics before earning his MS in Statistics from Purdue and PhD in Biostatistics from the University of Texas.
Lead or senior author on 10 peer-reviewed scientific manuscripts on aggregate safety assessments
His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck).
Greg co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group; he established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.