ARC Regulatory

Quality Management deficiencies can lead to operational hiccups, regulatory setbacks and unfavourable market reception. Proactive quality interventions can pre-empt these challenges’’. Our Senior Quality Assurance Lead Seamus Watson reminds us that using quality audits is crucial in managing your precision medicine partners as they: 1. Ensure Compliance: Ensure processes and practices comply with regulations, safeguard patients and maintain legal compliance/ Manage Data Integrity: Verify the integrity of data collection, storage, and analysis processes. 2. Verify Analytical Processes: Assess analytical processes, equipment and methods to ensure accuracy and reliability in delivering precise results. 3. Assess Lab Practices: Evaluate lab practices, including sample handling, equipment calibration and training to ensure that they meet the required standards. 4. Implement Risk Mitigation: Assess and mitigate risks, reducing the likelihood of errors data breaches or other issues that could negatively impact patient outcomes or the company's reputation. 5. Encourage Continuous Improvement: Identify areas for enhancement, implement best practices and optimise workflows. Identify Non-Conformity: Preventing potential errors or problems that could compromise quality, safety or regulatory compliance. 6. Build Stakeholder Trust: Demonstrate your commitment to maintaining high standards and enhancing the reputation of the company. 7. Ensure Partner Compliance: Ensure partners and suppliers meet the necessary quality standards, contributing to the overall integrity of the supply chain. To find out more, you can watch our webinar ‘How to manage Precision Medicine Partners Effectively’ here: https://bit.ly/4cB15ra

Did you know we have an in-house Quality division that covers the full spectrum of Quality Management, Compliance, and Auditing? Our expert Seamus Watson has over 20 years in quality management and 8 years in medical devices/IVDR. He has helped us put together our latest whitepaper ''The Secrets of Quality Audits'' which is an essential resource for industry professionals. Drawing on insights from ARC experts in quality auditing, it provides an overview of current industry trends and covers the following types of audits: - First Party Audits - Second Party Audits - Third-Party Audits - ISO Ready Audit / Gap Assessments Download and read it here: https://bit.ly/3YeRYbx

What is a CRO and why do you need one? Earlier this week, we caught up with Amanda Ball (Head of Global and Clinical Operations) to find out more about the crucial role that CROs play in the success of clinical trials and research projects. Here are some key takeaways: 1. Expertise and Resources: CROs offer specialized knowledge and resources, providing support in areas such as clinical trial management, data analysis, and regulatory compliance. 2. Cost and Time Efficiency: Outsourcing to a CRO can significantly reduce the time and cost associated with conducting clinical trials, allowing you to focus on core business activities. 3. Regulatory Compliance: CROs stay up-to-date with the latest regulatory requirements, ensuring that trials meet all necessary guidelines and standards. 4. Flexibility and Scalability: CROs provide scalable solutions tailored to the specific needs of your project, whether it's a small-scale study or a large, multi-centre trial. 5. Risk Management: With their extensive experience, CROs help identify and mitigate potential risks, enhancing the overall quality and success of your research. For more information or support, contact us today: https://bit.ly/3WgCl1u Or, in case you missed it, you can view our CRO webinar here: https://bit.ly/4bJIckM

ARC360 is revolutionising the way organisations access regulatory intelligence and, tailor study-specific information and guidance, based on how they are using in vitro diagnostics to select and manage patients in the IND trials. A truly unique offering, powered by the latest technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is a Regulatory Intelligence Platform, set to accelerate typical timelines for initiating complex clinical trials. ARC 360 key features and benefits: - Comprehensive Coverage: Access requirements for 40 central testing laboratories and sample collection sites across the EU, US, and the Rest of the World. - Regulatory & Ethics Approvals: Detailed information on notification/authorization, required documentation, submission modes, timelines, and fees. - Safety Reporting: Clear guidelines on requirements, responsibilities, reporting methods, and necessary forms. - Regulatory Authority Submission: In-depth submission format and content guidance to meet notification requirements. - Expert Insights: Gain the latest tips and learnings from our experts, based on their extensive experience with study applications and managing review responses. - SME Support: Accelerate your Dx study site activation and coordinate country start-up with your trial CRO. Don't let delays hinder your clinical development timelines. Get back on track with ARC360 our latest Regulatory Intelligence Platform - https://bit.ly/4cIkd6v Learn more about ARC360, get in touch with Darren Ross by either filling this form https://bit.ly/4cT7u0G or via email at [email protected] #ClinicalTrials #RegulatoryCompliance #ARC360 #ARCRegulatory #MedicalDevices #RegulatoryIntelligence

Event season is nearly here and we are looking forward to sharing our expertise internationally! In September, we will be flying to Hamburg to conduct a two-day seminar in partnership with qtec services GmbH on the 25th and 26th. Join our SME’s Amanda Ball (Head of Global Clinical Operations) and James Lappin (Head of Clinical Compliance & Quality Assurance) In this two-day conference, where you will not only expand your specialist knowledge of the IVDR, but will also come into direct contact with notified bodies, authorities and other manufacturers, allowing you to better understand the different perspectives of the stakeholders, exchange experiences and expand your network of expertise. The agenda is as follows: Day 1: 25th September Amanda Ball will be presenting "A Journey through Clinical Performance Study start-up and monitoring: A how to guide on best practices and pitfalls." Day 2: 26th September James Lappin will be presenting on "CDx performance study requirements and submissions under IVDR" We have limited slots remaining, register for this event here: https://bit.ly/3XVRbvL" To find out more, visit our website: https://bit.ly/3zvcnhU

We're #hiring a new Clinical Project Manager, Translational Biomarkers in Belfast Metropolitan Area. Apply today or share this post with your network.

In May we released some information on the final LDT rule (Laboratory Developed Tests) marking a significant shift in regulatory oversight. This new rule aims to improve the safety and effectiveness of LDTs by ending the agency's enforcement discretion. What does this mean for your clinical trials? Compliance with investigational use requirements (21 CFR 812) begins in stage 2, two years after the rule's publication. Ensuring your LDTs meet these standards is crucial for maintaining the integrity and safety of your clinical investigations. To learn more about preparing for these changes and to get guidance on planning your clinical trials, read our first blog post here: https://bit.ly/3WfanTY Stay up to date with the ever-changing regulatory landscape by signing up to our mailing list here: https://bit.ly/3zAnw18 #FDA #LDT #RegulatoryCompliance #ClinicalTrials #MedicalDevices #ARCRegulatory #Regulations #IVD

Struggling with clinical trial compliance? Benefit from an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests, dose adjustments and other patient sample testing in pharma and biopharma trials around the globe with ARC360. Learn more from Darren Ross during an interview state-side. #IVD #ClinicalStudies #RegulatoryCompliance #IVDR #ARCRegulatory https://lnkd.in/eqwxaiVU

💥Very enjoyable evening with the Catalyst community, lots of laughs with the ARC Regulatory team, massive thank you to the whole Catalyst team for providing such a great community get together!💥#ARC360 #Team #BBQ #Community #Ecosystem #Summer #Euros #Football 🎉😎🌭🍔🍺

Happy to have just started as Senior Product Manager at ARC Regulatory located in Catalyst, Queen’s Road. The Team have all been so welcoming, friendly and informative to date and I’m excited to get more involved with ARC360. Situated beside ECIT, Queen's University Belfast where I carried out PhD research many years ago! Seems I’ve come full circle back to where it all started :)