Diligent Pharma

We’re excited to share the second post in our #StayingDiligent series! At Diligent Pharma, our team of quality experts continues to track the latest developments in regulatory affairs, compliance, and clinical research to keep you informed.   Here’s what’s making waves in the pharmaceutical and biotech world: - Could the Fed’s Interest Rate Cut Spur Investment in Biotech Companies (biopharmadive.com, Sep 20, 2024) - CRDSA Announces Publication of Standards for Clinical Trial Data Reuse (Clinical Research News Online, Sep 26, 2024) - FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration (fda.gov, Sep 20, 2024) - FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine (jamanetwork.com, Oct 15, 2024)   #RegulatoryAffairs #PharmaceuticalIndustry #ClinicalTrials #QualityCompliance #FDA #Biotech #DataStandards #ClinicalData #AIinHealthcare #InnovationInMedicine #PharmaNews #RegulatoryUpdates #StayingDiligent

Vendor Qualification Made Easy Tired of redundant audits slowing down your clinical trials? Diligent Pharma has the solution! With our centralized Vendor qualification model, multiple Sponsors benefit from a single, compliant qualification process, saving time and boosting efficiency.   Here’s how we can help: - Proven, FDA-accepted model  - Tailored to your specific needs  - Rigorous compliance & quality assurance  - Discover top Vendors in emerging fields    Streamline your Vendor qualification and focus on what matters—your trial’s success. Learn more 👉 https://lnkd.in/dPUpYyR3 #ClinicalTrials #Pharma #VendorQualification #Compliance #Innovation

Day 2 at SCOPE Europe and the energy here in Barcelona is incredible! Diligent Pharma’s CEO Patricia Leuchten wrapped up an insightful panel yesterday on the anticipated impact of ICH E6 R3, with industry leaders Solomon Babani, Sandy Smith, RN, MSN, AOCN, and Joanna Florek-Marwitz. They explored the expected challenges and opportunities the new guidance brings, sharing data-driven perspectives and sparking thought-provoking discussions on clinical trial execution.   Our team is excited to connect with so many visionary leaders and innovators here. If you’re attending, join Patty’s fireside chat today at 2:40pm, “Redefining Excellence: The Future of Clinical Trial Quality” featuring expert panelists Coleen Glessner and Kristine Koontz, PhD, MBA. Together, they’ll dive into how advancements in AI, Big Data, and Real-World Evidence are transforming quality management in clinical research.   #SCOPEsummit #SCOPEEU #ClinicalTrialQuality #Regulatory #ICHE6R3 #Barcelona2024 #ClinicalResearch

SCOPE Europe Summit is here! We’re thrilled to be joining clinical research leaders and innovators in Barcelona this week (October 29-30) at the 7th Annual Summit for Clinical Ops Executives. Our CEO, Patricia Leuchten, will lead two can’t-miss sessions: Panel Discussion: Senior Clinical Trial Leaders Discuss and Debate the Impact of ICH E6 R3, the Expected Challenges, and the Opportunities 🗓️ Tuesday, October 29, at 4:32 pm Patty will moderate this panel with senior leaders Solomon Babani, Sandy Smith, RN, MSN, AOCN and Joanna Florek-Marwitz. They’ll dive into the challenges and opportunities presented by the highly anticipated release of ICH E6 R3. Fireside Chat: Redefining Excellence - The Future of Clinical Trial Quality 🗓️ Wednesday, October 30, at 2:40 pm Joined by Coleen Glessner and Kristine Koontz, PhD, MBA, Patty will explore how technologies like AI, Big Data, and Real-World Evidence are reshaping quality management in clinical trials. Don’t miss the chance to learn from these industry veterans as they discuss pivotal milestones and emerging paradigms in quality management. #ClinicalResearch #SCOPEsummit #SCOPEEurope #ClinicalQuality #ClinicalOpsExcellence #Barcelona2024 #ICHE6R3

What an incredible time at OCT New England! A huge thanks to everyone who attended Anthea Dransfield’s talk on “Reducing Trial Start-Up Time Through an Innovative Approach to Vendor Qualification.” Missed the session? No worries—there’s still time to stop by our booth and chat with our team about how Diligent Pharma’s data-driven, risk-based approach can revolutionize your vendor management practices. Reach out or come by booth #82 for a chat. Let’s connect and explore collaboration opportunities! #OCTNewEngland #ClinicalTrials #VendorQualification #DiligentPharma #ClinicalOperations Arena International Events Group

Ready to transform the way you manage Vendor Qualification? Join us at #OCTNewEngland on October 23-24 for a groundbreaking session by Anthea Dransfield, Head of Quality at Diligent Pharma. Anthea will lead a presentation on "Reducing Trial Start-Up Time Through an Innovative Approach to Vendor Qualification". Stop by booth #82 for a deeper dive into how Diligent’s centralized vendor management model can speed-up vendor onboarding, strengthen your compliance process, and improve efficiency in your clinical trials. 📅 Session Date & Time: October 23, 2024 at 9am 📍 Location: Westin Boston Seaport, Boston, USA We’re driving efficiencies for both Sponsors and Vendors across the industry! Let’s explore ways to collaborate and streamline your trial operations. Arena International Events Group #OCTNewEngland #ClinicalTrials #VendorManagement #ClinicalResearch #Innovation #DiligentPharma 

Join us at #OCTNewEngland on October 23-24, 2024 in Boston for an insightful session by Anthea Dransfield, Head of Quality at Diligent Pharma. Anthea will be sharing Diligent’s perspective on how we can help the industry “Reduce Trial Start-Up Time Through an Innovative Approach to Vendor Qualification”. Discover how adopting a risk-based, data-driven approach can lead to faster onboarding, greater compliance, and a smoother experience for both Sponsors and Vendors. Don’t miss out on learning how the Diligent innovation can drive efficiencies in clinical trial execution! 🗓️ Session Date & Time: October 23, 2024 at 9 am 📍 Location: Westin Boston Seaport, Boston, USA We look forward to seeing you there! Arena International Events Group #OCTNewEngland #ClinicalTrials #Innovation #DiligentPharma #VendorQualification #ClinicalResearch

Driving Innovation Together: Diligent Pharma x GenVault   We’re thrilled to announce our collaboration with GenVault, a provider of bioinventory storage solutions and lab transport services.   By leveraging GenVault's Qualification Package on the Diligent Platform, clients can now qualify GenVault in just days. GenVault continues to innovate to drive efficiency—helping clients save time, streamline resources, and accelerate their onboarding processes. Diligent supports GenVault's mission to give its clients more time to focus on innovation.   Discover how Diligent Pharma and GenVault are shaping the future of vendor qualification and how to access the GenVault Qualification Package today. 🔗 Learn more: https://lnkd.in/dAcA8gij   #Innovation #VendorQualification #ClinicalTrials #DiligentPharma #GenVault #StreamlinedProcesses #PharmaInnovation #FutureOfClinicalTrials #LifeSciences

Exceeding expectations and delivering value. Our partner Cerevel shares how our consistent assessment criteria and cost-effective audit process have made a real difference to their vendor qualification process. Read the full success story here to learn more: https://lnkd.in/d3AsqiB2 #DiligentPharma #VendorQualification #SuccessStory

At Diligent Pharma, our quality experts are always at the forefront of regulatory, quality/compliance, and clinical trial industry developments. We're excited to launch Staying Diligent – a curated series of key updates to keep you informed.   Stay tuned for more industry insights!   Sources: - FDA Announces 7 New Clinical Trial Grants under the Orphan Product Grants Program (fda.gov, Oct 1, 2024) - MHRA launches Strategy for Improving Safety Communications on World Patient Safety Day (www.gov.uk, 17 Sep 2024) - FDA Issues Final Guidance Document on Conducting Clinical Trials With Decentralized Elements (FDA.gov, September 2024)   #RegulatoryAffairs #PharmaceuticalIndustry #ClinicalTrials #QualityCompliance #FDA #MHRA #OrphanDrugs #PatientSafety #DecentralizedTrials #PharmaQuality #DrugDevelopment #LifeSciences #BioPharma #RegulatoryIntelligence #PharmaTech #HealthcareInnovation #MedicalResearch #DrugSafety #PharmaNews #RegulatoryStrategy