How PointCross Life Sciences accelerates eCTD safety table creation

Health Canada Tightens eCTD Validation Criteria: Updated validation standards from Health Canada on electronic Common Technical Document (eCTD) submissions aim to improve acceptance rates and reduce delays. Key points:  ➡️Automation combined with structured content diminishes manual errors   ➡️Streamlined workflows speed time to market without compromising compliance Stay ahead with compliant automation tools. Guidance → https://lnkd.in/ebXWxyr Get insights into documentation automation → https://lnkd.in/gdTrUPhi   

𝐓𝐡𝐞 𝐁𝐘𝐎𝐓 𝐏𝐥𝐚𝐲𝐛𝐨𝐨𝐤 - 𝐁𝐞𝐲𝐨𝐧𝐝 𝐞𝐂𝐨𝐧𝐬𝐞𝐧𝐭: 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 2 𝐨𝐟 𝐁𝐘𝐎𝐓. In the first part of our BYOT series, we explored how Bring Your Own Technology empowers sites to use their preferred eConsent tools to drive faster participant enrollment, smoother workflows, and higher data integrity. Next, the BYOT framework expands to include: ✔ 𝐞𝐒𝐨𝐮𝐫𝐜𝐞. Sites capture data directly from the source, using their own validated systems, ensuring data accuracy and reducing transcription errors. ✔ 𝐞𝐑𝐞𝐠. Sites manage regulatory binders and investigator files with the systems they already trust, keeping compliance and inspection readiness in their control. ✔ 𝐃𝐢𝐫𝐞𝐜𝐭 𝐃𝐚𝐭𝐚 𝐂𝐚𝐩𝐭𝐮𝐫𝐞 (𝐃𝐃𝐂). Data moves seamlessly from site systems to sponsor databases, reducing redundancy and accelerating study timelines. All connected through universal data standards like CDISC ODM, USDM, and FHIR—the backbone of interoperability and a win-win for stakeholders. → Sites work the way they want. → Sponsors get the quality, visibility, and compliance they need. This is the future of flexible, interoperable clinical research technology, what the BYOT Playbook calls Horizon 2. 🔗 Explore Horizon 2 and the BYOT Playbook: https://lnkd.in/g4yMW5xs #BYOT #BringYourOwnTechnology #SiteSuccess #InnovativeSolutions #eClinicalSolutions #ClinicalTrials #ClinicalResearch

𝐓𝐡𝐞 𝐁𝐘𝐎𝐓 𝐏𝐥𝐚𝐲𝐛𝐨𝐨𝐤 - 𝐁𝐞𝐲𝐨𝐧𝐝 𝐞𝐂𝐨𝐧𝐬𝐞𝐧𝐭: 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 2 𝐨𝐟 𝐁𝐘𝐎𝐓. In the first part of our BYOT series, we explored how Bring Your Own Technology empowers sites to use their preferred eConsent tools to drive faster participant enrollment, smoother workflows, and higher data integrity. Next, the BYOT framework expands to include: ✔ 𝐞𝐒𝐨𝐮𝐫𝐜𝐞. Sites capture data directly from the source, using their own validated systems, ensuring data accuracy and reducing transcription errors. ✔ 𝐞𝐑𝐞𝐠. Sites manage regulatory binders and investigator files with the systems they already trust, keeping compliance and inspection readiness in their control. ✔ 𝐃𝐢𝐫𝐞𝐜𝐭 𝐃𝐚𝐭𝐚 𝐂𝐚𝐩𝐭𝐮𝐫𝐞 (𝐃𝐃𝐂). Data moves seamlessly from site systems to sponsor databases, reducing redundancy and accelerating study timelines. All connected through universal data standards like CDISC ODM, USDM, and FHIR—the backbone of interoperability and a win-win for stakeholders. → Sites work the way they want. → Sponsors get the quality, visibility, and compliance they need. This is the future of flexible, interoperable clinical research technology, what the BYOT Playbook calls Horizon 2. 🔗 Explore Horizon 2 and the BYOT Playbook: https://lnkd.in/eiMCsJEa #BYOT #BringYourOwnTechnology #SiteSuccess #InnovativeSolutions #eClinicalSolutions #ClinicalTrials #ClinicalResearch

𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗦𝗮𝗠𝗗 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗽𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲𝗹𝘆: 𝗜𝗠𝗗𝗥𝗙 𝗼𝗽𝗲𝗻𝘀 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 𝗼𝗻 𝗣𝗿𝗲𝗱𝗲𝘁𝗲𝗿𝗺𝗶𝗻𝗲𝗱 𝗖𝗵𝗮𝗻𝗴𝗲 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗣𝗹𝗮𝗻𝘀. The International Medical Device Regulators Forum (IMDRF) has released a draft document on Predetermined Change Control Plans (PCCPs) — and is now inviting feedback via public consultation until 8 December 2025. 𝗪𝗵𝗮𝘁’𝘀 𝗶𝘁 𝗮𝗯𝗼𝘂𝘁? The document outlines a global approach for managing planned changes in medical device software, including Software as a Medical Device (SaMD). PCCPs are intended to streamline regulatory approvals by pre-authorising certain types of software modifications — like model updates or performance improvements — without requiring a full new submission each time. 𝗧𝗵𝗲 𝗱𝗿𝗮𝗳𝘁 𝗰𝗼𝘃𝗲𝗿𝘀: ⏺ 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 — such as risk-based, transparent, and evidence-led planning ⏺ 𝗞𝗲𝘆 𝗲𝗹𝗲𝗺𝗲𝗻𝘁𝘀 — including the change description, plan, and impact assessment ⏺ 𝗕𝗲𝗻𝗲𝗳𝗶𝘁𝘀 — like faster access for patients and more efficient updates ⏺ 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 — including international alignment and submission complexity 👉 https://lnkd.in/g-FUefst

🗣️ The state of the art (SOTA) for a medical device should be at the beginning of every medical device development and accompany the product until the end. 👉 Do you agree? If not, why? 👉 And is this approach already being practised in your company? --- To be honest, for many years, the "medical/clinical SOTA" was a by-product of clinical evaluation for me. It was often only described in the Clinical Evaluation Report, which was finalised for the CE conformity assessment. And the "technical SOTA" was usually a list of applicable standards and guidelines, combined with the knowledge of the most experienced development engineers. --- This perspective changed fundamentally when I started to digitalise #medicalDevice lifecycle processes for product development, risk management, #clinicalEvaluation and PMCF/PMS.   When it comes to #digitalisation, we don't think in terms of documents, but rather individual data elements: ❇️ When is information first created and documented as part of which process (single source of truth)? ❇️ Where is information needed as input for another process and reused there? This methodology requires a completely different approach to SOTA in comparison to Word File based documentation - and also an adaptation of relevant processes and their interfaces. --- Together with other experts from the industry, I have discussed the SOTA topic repeatedly over the last few years and worked on best practice solutions and process flowcharts. At this point, I would like to express my special thanks to Markus Pöttker, Alexej Agibalow, Florian Tolkmitt and Edward B. for the exchange of ideas and mutual inspiration. 🤔 The resulting outcome and a recommendation for best practice? I will be presenting this in a talk at the qtec services GmbH conference for clinical evaluations "Klinisch 2.0" on 19 November in Hamburg and discussing it with the participants. 👉 Should I share some of the results here on LinkedIn afterwards? Let me know if you are interested in this topic! #medtech #technicalDocumentation

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

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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

🚀 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