PointCross Live Discussion – Recent Regulatory and Standards Updates
Recent FDA Regulatory and Standards UpdatesTuesday, December 11th, 2018
PointCross Testing
PhUSE CSS Computational Science Symposium
Kavan Palangappa2024-06-14T06:11:34+00:00March 4 – 6, 2018 | Silver Spring, MD
Benchmark Your SEND Readiness Whitepapers
Kavan Palangappa2024-06-14T06:11:35+00:00Benchmark Your SEND Readiness
Synthetic Dataset
Kavan Palangappa2024-06-14T06:11:37+00:00Synthetic Dataset for Public Use (PC201708)
Integrating Clinical, Biomarker & Disparate Data
Kavan Palangappa2024-06-14T06:11:37+00:00Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
Introducing PointCross Desktop Validator
Kavan Palangappa2024-06-14T06:11:39+00:00July 20 2022 - PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing...
SEND ASSURE™ Whitepaper
Kavan Palangappa2024-06-14T06:11:39+00:00Assuring your SEND Datasets are Consistent with your Study Report...
Data Standardization Services
Kavan Palangappa2024-06-14T06:11:41+00:00Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
Kavan Palangappa2024-06-14T06:11:43+00:00PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA on their KickStart program to ensure that received datasets are suitable for pharm/tox review...
PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions
Kavan Palangappa2024-06-14T06:11:44+00:00XYBION AND POINTCROSS ESTABLISH A STRATEGIC PARTNERSHIP TO DELIVER SEND SERVICES TO ASSURE FDA REVIEW READY SUBMISSIONS March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s...