PointCross Life Sciences Inc. software

A format agnostic solution for harmonization across clinical, molecular biomarker, nonclinical and preclinical data for searchable cross study analysis.

Digital Metadata Governance & Clinical Regulatory Compliance: Management and governance of CDISC and corporate standards driven metadata, data models and study level models from protocol to submission with workflows and controls. Solution for clinical trial data submissions in CDISC SDTM to comply with FDA and PMDA mandates. Accept and validate data from CROs with centralized data management and provisioning to biostatisticians and programmers for data analysis. Plan interim and final submissions, package M5 folders with ISS, ISE and TFLs for submitted studies.