In this webinar, we discussed how SEND-ASSURE ensures consistency with the audited Study Report, conformance to Technical Rejection Criteria guidelines, and follows details of the Technical Conformance Guide as the trusted references for data submission and regulatory compliance. Key Takeaways: The most common errors in SEND with recommendations to correct them Feedback related to submission and analysis Pinpoint QC ideas Submit...
PointCross was present at the 2024 SOT #ToxExpo. Date: March 10–14, 2024 Salt Palace Convention Center in downtown Salt Lake City, Utah Takeaways: CROs and Sponsors love PointCross’ instant SEND quote generator, fast turnaround time, and study data visualization offering Integrating bioanalytical and complex biomarker data with as collected in-life data can be done in real time and people loved seeing subject level study details for ongoing...
In nonclinical studies, waiting until the completion of a study to make data-driven decisions may limit the potential for valuable insights. Traditional study reports published post-completion often lack the ability to provide on-study analysis and early indicators crucial for driving amendments and gaining deeper insights. Here comes Xbiom™ Insights, a cutting-edge interim nonclinical study...
PointCross Life Sciences was thrilled by the level of interest and excitement with regards to the poster we presented at PhUSE Connect 2024, titled “Rapid SDTM and Compliance Dashboards”. We had some important dialogue with industry peers and leaders in the space pertaining to revolutionizing SDTM development in clinical research. Key Takeaways: Integration of Standards and...
Phuse poster jointly worked with PointCross Lifesciences and Roche
Introduction In the fast-paced world of life sciences validation software, accurate and compliant data validation is crucial for successful clinical and nonclinical study submissions. Ensuring the integrity of Clinical SDTM, ADaM datasets, and Nonclinical SEND data is no easy task, considering the complexity and vastness of datasets involved. In this blog, we introduce you...
Introduction Regulatory agencies like FDA require all nonclinical study data submitted for IND or NDA submissions to be in CDISC SEND format. The Clinical Data Interchange Standards Consortium (CDISC) has established a set of open data standards for the representation and exchange of standardized study data collected over the course of nonclinical and clinical studies....
View Webinar Recording: eDataValidator (eDV) for Validating SDTM, ADaM & SEND Click here to sign up for eDataValidator Having trouble viewing the video? Please click here Here is a brief overview of the webinar's key highlights and takeaways. In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or...
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 demand from sponsor Clinical...