Allucent

Click here https://lnkd.in/gfsWXide to check out our updated blog on CDISC standards! Understanding CDISC is instrumental in successfully navigating the complex world of clinical trials. Informed by the FDAs latest guidance, What is CDISC and What are CDISC Standards, covers the role of CDISC in clinical research and the foundational standards like SDTM, ADaM, and more. #ClinicalResearch #CDISC #CRO #ClinicalPharmacology #Pharmacokinetics #DoseOptimization

Our next installment of the A-Team Spotlight series highlights Melanie Buitendyk, MSc (Sr. Director, Biostatistical Consulting)! With more than 20 years of experience in the clinical trial industry, Melanie has deep experience in statistical consulting and project execution. She supports clinical program development including long-term planning, agency documentation/meeting support, study design (including adaptive designs) and protocol development, sample size, endpoint selection and statistical methodology. Melanie supports ad hoc/exploratory analysis needs, sponsor reporting needs, is flexible, and pivots with sponsor priorities. She possesses therapeutic expertise in a multitude of disciplines, including cardiovascular disease, infectious disease, neurology, rare diseases, and gene therapies, among others. Along with her biostatistical and therapeutic expertise, Melanie's ability to integrate into the sponsor core team with an understanding of sponsor goals and end product is exceptional. Connect with Melanie and visit our website to learn more about Allucent's Biostatistical Consulting services: https://lnkd.in/gxp_hPba #Allucent #BringNewTherapiesToLight #Biostatistics #StudyDesign #ProtocolDevelopment #RegulatoryAffairs

Ensuring inspection readiness is critical in clinical trials, and the updated ICH E6(R3) guidelines are reshaping the approach. In our latest webinar https://lnkd.in/g4qHdNHu, Allucent GXP expert, J Ernesto Vera-Sánchez, MD, PhD, MPH, dives into the key changes, including risk-proportionate strategies and the importance of data governance, patient safety, and regulatory compliance. Learn how to proactively manage risks, prepare your team for inspections, and stay compliant across all trial phases. Watch now for actionable insights to strengthen your inspection readiness and improve trial outcomes. #GCP #ICH #ClinicalTrials #Regulatory #InspectionReadiness #RiskManagement

Partnering with Allucent means you have a true partner in your drug development journey. Katy Moore, PharmD, RPh, President of Clinical Pharmacology Modeling and Simulation, was interviewed by Biotech TV and shared the ways Allucent ensures our clients get it right to bring new therapies to light. Click here (https://lnkd.in/gfTZHRnc) to learn more about Allucent’s clin pharm solutions.

Read our latest case study from Rachel Rozakis, PharmD, to learn how the A-Team designed a thorough QT (TQT) study that ensured robust data collection while prioritizing patient safety: https://lnkd.in/gFaBEinv. Our strategic approach with a tailored study design provided the successful characterization of exposure-response for QT prolongation and enabled our client to advance development confidently.    #ClinicalPharmacology #CardiacSafety #TQTStudy #DrugDevelopment #Allucent

In addition to the great work we do to ensure client success, our employees create opportunities to spend time and share invaluable experiences with one another outside of the regular office routine of meetings and video calls. If you, too, want to be part of the A-Team, check out our great career opportunities, https://lnkd.in/epXrH2RT.

A recent revision of the ICH E6 Guideline, specifically ICH E6(R3), addresses the expanded scope of clinical trial designs, ensuring that GCP principles are applied to a broader range of designs and execution, incorporating a proportionate risk-based approach, and increasing flexibility to meet the demands of a global environment. Check out our blog https://lnkd.in/dme4Xa_S where our GxP expert, J Ernesto Vera-Sánchez, MD, PhD, MPH, dissects the key changes presented in this draft document, as well as proactive insights on integrating ICH E6(R3) into your clinical trials. Dr. Vera Sanchez led a webinar on this topic this morning! Watch for an upcoming LinkedIn post to learn how you can access that webinar recording. #Allucent #BringNewTherapiesToLight #RegulatoryCompliance #DataGovernance #PatientCentricity #ICH #InspectionReadiness

This week we are highlighting A-Team expert, Nuno Pires, MSc! With over 9 years of professional experience in pharmaceutical and health inspections and prior ventures as a practicing pharmacist and registered nurse, Nuno provides sharp insights and informed leadership to the GxP Strategy team. He is highly proficient in Good Clinical Practice (GCP), (regulatory) inspections, and clinical trial regulations, bringing expert know-how in conducting GCP and GLP audits, mock inspections, and inspection-readiness activities as well as activities related to the management of quality defects, rapid alert notifications, and recalls processes. Further enhancing his already impressive endeavors, Nuno has deep experience as a GCP and pharmacovigilance inspector, having conducted inspections for INFARMED, the Portuguese Health Authority responsible for the regulation of pharmaceuticals, and on behalf of the EMA. We are thrilled to have him on our team! Connect with Nuno Pires and visit our website to learn more about Allucent's GxP Consulting services: https://lnkd.in/gJ4Psaeb #Allucent #BringNewTherapiesToLight #RegulatoryCompliance #GCP #InspectionReadiness #GXP #Pharmacovigilance

The theme for Human Rights Day 2024 is "Dignity, Freedom, and Justice for all." At Allucent, we believe that every individual deserves to be treated with respect and dignity. It is our duty to uphold these principles and be a part of the effort to advance them in our workplaces and communities. #Allucent #BringNewTherapiesToLight #HumanRightsDay #Equality

Join us this Thursday, December 12th, for an engaging webinar featuring Allucent's GxP expert, J Ernesto Vera-Sánchez, MD, PhD, MPH, where he will discuss the recent updates to the ICH E6 (R3) draft guidelines, as well as actionable strategies to adhere to these changes. These updates impact critical aspects of inspection readiness, particularly in data governance, with a focus on managing data integrity, traceability, and security in clinical trials. Listeners will gain valuable insights to help navigate the complex regulatory landscape and ensure comprehensive inspection readiness.   Register here: https://lnkd.in/gTcEcwTB   #Allucent #BringNewTherapiesToLight #GxP #InspectionReadiness #FDACompliance #DataGovernance #RegulatoryCompliance