🚀 New !! Our latest publication, “Pre-Trial Testing of Case Report Forms in EDC Systems,” outlines a structured framework to ensure flawless data capture before clinical trials go live. We dive into: ✅ Quality assurance with audit logs and mock data. ✅ Step-by-step validation of CRFs using REDCap and APIs. ✅ Workflow simulations and import/export integrity checks. ✅ User acceptance testing and documentation best practices. By integrating human-centered testing, automation, and regulatory rigor, this guide helps research teams enhance protocol adherence, data reliability, and trial readiness. 🔗 https://lnkd.in/dC_bGSmG #SporeDataResearch #ClinicalResearch #DataQuality #EDC #ClinicalTrials #DigitalHealth 

🚀 New !! Our latest publication, “Pre-Trial Testing of Case Report Forms in EDC Systems,” outlines a structured framework to ensure flawless data capture before clinical trials go live. We dive into: ✅ Quality assurance with audit logs and mock data. ✅ Step-by-step validation of CRFs using REDCap and APIs. ✅ Workflow simulations and import/export integrity checks. ✅ User acceptance testing and documentation best practices. By integrating human-centered testing, automation, and regulatory rigor, this guide helps research teams enhance protocol adherence, data reliability, and trial readiness. 🔗 https://lnkd.in/dpjEvCqa #SporeDataResearch #ClinicalResearch #DataQuality #EDC #ClinicalTrials #DigitalHealth 

FDA Computer System Assurance We explore the FDA's final Computer System Assurance (CSA) guidance and the most significant updates from the draft version. These updates are reshaping how life sciences and healthcare technology companies validate and maintain compliant systems in a rapidly evolving digital environment.  Read the full breakdown and share your perspective in the comments. #FDAGuidance #ComputerSystemAssurance #RegulatoryCompliance #HealthcareTech #SoftwareRegulations #LifeSciences #Validation

Quality control and compliance don’t have to be a time-consuming headache! See how integrating Data Innovations middleware with a Cerner Millennium LIS empowers labs to automate QC, streamline regulatory reporting, and proactively manage instrument performance. You’ll not only improve your lab’s quality, you’ll free up lab resources to focus on other priorities! Learn more from our tips on how to Revolutionize Your Cerner lab: https://hubs.la/Q03SpC9N0 #LabQuality #Cerner #HealthcareCompliance

Real-world data is only as powerful as its accuracy. When ePRO and EDC operate in silos, delays and discrepancies creep in, weakening the reliability of your RWD. Clinion’s integrated ePRO–EDC platform ensures every patient-reported outcome flows directly into your clinical database, clean, validated, and analysis-ready. ✅ Strengthen RWD quality with seamless data sync ✅ Eliminate manual transfers and data loss ✅ Gain real-time visibility across your study Because reliable RWD begins with connected systems. Unify your data with Clinion’s integrated ePRO and EDC→ https://lnkd.in/gT-nGbMC #ePRO #EDC #RWD #RWE #AIinClinicalTrials #RealAI #AIML #GenAI #ClinicalDataManagement #RealAIRealImpact #ClinionAI #ClinionInnovation #NextGenWithClinion

Real-world data is only as powerful as its accuracy. Clinion’s integrated ePRO–EDC platform ensures every patient-reported outcome flows directly into your clinical database, clean, validated, and analysis-ready. ✅ Strengthen RWD quality with seamless data sync ✅ Eliminate manual transfers and data loss ✅ Gain real-time visibility across your study Because reliable RWD begins with connected systems. Unify your data with Clinion’s integrated ePRO and EDC→ https://lnkd.in/gT-nGbMC

It still shocks me how many large CROs don’t have an eTMF—or worse, don’t understand what one is. In 2025. When everything in clinical research is moving toward automation, transparency, and remote oversight… hearing “we still use paper” makes me cringe. Paper isn’t just outdated—it’s a liability. It slows audits, delays filings, and hides insights that could actually improve trial quality. The truth is simple: • eTMF isn’t optional anymore. • Paper isn’t just inefficient—it’s a compliance risk. • The future of TMF management is real-time, not reactive. Are we still treating electronic systems as “nice to have”? Or finally accepting they’re the backbone of modern clinical operations? Full interview: https://lnkd.in/d4752xaD #ClinicalTrials #TMF #DigitalTransformation #CRO #QualityManagement Deivis Mercado Jeremy Whittaker Meera Lakhani-Patel Natasha G. Veeva Systems Steph Viscomi Apellis Pharmaceuticals

𝐞𝐂𝐓𝐃 𝐬𝐚𝐟𝐞𝐭𝐲 𝐭𝐚𝐛𝐥𝐞𝐬 𝐝𝐨𝐧’𝐭 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐛𝐞 𝐬𝐥𝐨𝐰, 𝐦𝐚𝐧𝐮𝐚𝐥, 𝐨𝐫 𝐞𝐱𝐩𝐞𝐧𝐬𝐢𝐯𝐞. Sponsors and CROs have long accepted that eCTD tabulation is just another costly, time-consuming step between data and submission. 𝘉𝘶𝘵 𝘵𝘩𝘢𝘵’𝘴 𝘤𝘩𝘢𝘯𝘨𝘪𝘯𝘨. At PointCross Life Sciences, our data standardization services go beyond our proven SEND automation pipeline to deliver turnkey eCTD safety tables — 𝘧𝘢𝘴𝘵𝘦𝘳, 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦𝘭𝘺, 𝘢𝘯𝘥 𝘢𝘵 𝘢 𝘧𝘳𝘢𝘤𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘳𝘢𝘥𝘪𝘵𝘪𝘰𝘯𝘢𝘭 𝘤𝘰𝘴𝘵. 💡 𝐇𝐞𝐫𝐞’𝐬 𝐰𝐡𝐲 𝐢𝐭 𝐦𝐚𝐭𝐭𝐞𝐫𝐬: - Every IND submission requires eCTD tables summarizing nonclinical safety data. - Most organizations relying on manual formatting and rework, and price tags often . PointCross 𝐚𝐜𝐜𝐞𝐥𝐞𝐫𝐚𝐭𝐞𝐬 the entire process — using 𝐗𝐛𝐢𝐨𝐦™ to generate tabulations directly from SEND datasets, LLM tools to extract and structure findings from Study Reports, and Reconciler to ensure every result aligns perfectly with the study’s conclusions. The outcome is simple: ✅ Faster turnaround ✅ Higher accuracy ✅ Full audit traceability ✅ Lower total cost And here’s the real value — your team can focus on orchestrating the scientific story for the FDA, while we handle the tables. You focus on 𝐢𝐧𝐬𝐢𝐠𝐡𝐭. We handle the 𝐞𝐱𝐞𝐜𝐮𝐭𝐢𝐨𝐧. #eCTD #ClinicalTrials #DataStandardization #RegulatorySubmission

Data Integrity — The Silent Strength of Every Clinical Trial In clinical research, every dataset and document forms the backbone of decision-making. Data integrity isn’t just about accuracy — it’s about trust. · From CRF entries to eTMF uploads, every action should follow the ALCOA+ principles —ensuring traceability and reliability. · Integrating systems like EDC, CTMS, and eTMF reduces manual handoffs and maintains a single source of truth. · Regular QC checks and metadata reviews ensure consistency across study phases. · True data quality isn’t a one-time activity — it’s a culture of continuous validation and shared accountability. · Proud to see our industry increasingly recognize that *clean data = credible science. #ClinicalResearch #DataIntegrity #ClinicalOperations #eTMF #ALCOA #Quality #ClinicalTrials

https://lnkd.in/gYhY2ApS FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. This guidance: • Describes “computer software assurance” as a risk-based approach to establish confidence in the automation used for production or quality systems, and identifies where additional rigor may be appropriate; and • Describes various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in quality system obligations, including requirements in 21 CFR Part 820 (hereafter referred to as “Part 820”).2 1 This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Inspections and Investigations (OII).