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Let's talk about the long-awaited update to the FDA guidelines on diversifying patient enrollment... #parexel #ACRO #withheart #patientsfirst #FDA #allpatients
A big step towards a more comprehensive understanding of treatment efficacy!
Chief Patient Officer Stacy Hurt 🌻joined Alicia C. Staley of Medidata Solutions to kick off Season 2 of ACRO's Good Clinical Podcast with Sophia McLeod! 🎧 Tune in to hear how Stacy’s experiences as a patient and caregiver have shaped her perspective on the vital role of the patient voice in reducing burden and turning buzz words into action! 💪 https://lnkd.in/gdMz_agR
Are biomarkers the key to diagnosing and treating cancer effectively? 🔑 They help identify patients who will benefit most from targeted therapies, making clinical trials faster and more efficient. However, reliable biomarkers are still lacking for many cancers. 🔎 At Parexel, our team of experts is leveraging diverse data streams and exciting advances in #AI and #machinelearning to fast-track cancer research and improve patient outcomes. We asked Angela Qu to describe how recent advances in multi-omics and computational analytics accelerate the discovery and validation of biomarkers in precision oncology. Read her responses here: https://lnkd.in/g2RPNWNS #Biomarkers #Oncology #PrecisionOncology #NovelInsights
Over the past three years, Parexel and Veeva Systems have collaborated to accelerate clinical trials through Veeva’s suite of technology applications, including Veeva Vault eTMF, Vault CTMS, Veeva EDC and Vault Study Startup. Together we've streamlined trial processes, created efficiencies and made clinical trial participation easier for all. 💪 Parexel colleagues connected recently with the Veeva team to discuss ways to further enhance the clinical trials experience for participants, patients and site professionals. Exciting times ahead as we continue to innovate and transform clinical research! #Veeva #ClinicalTrials #Collaboration
The potential of human gene editing to change the lives of those with genetic diseases cannot be understated. 🧬 In response to substantial growth in the development of therapies utilizing these technologies, the FDA released draft guidance earlier this year. 📝 In this edition of the New Medicines, Novel Insights newsletter, regulatory experts at Parexel discuss key takeaways from the FDA’s guidance on nonclinical assessment and identify important considerations for future gene editing product development. Discover more about the nonclinical studies and other requirements to support a successful IND submission for an investigational product. Read the full article below and subscribe to stay updated on the latest #NovelInsights from our bi-weekly clinical research newsletter! #FDA #Regulatory #GeneEditing
In the next blog in our oncology series, Stacy Hurt 🌻, Kristina Reeder, and Nichola Gokool examine how patients’ input is crucial in drug development and how Parexel incorporates patient voice throughout the research process. Our experts outline a proven 4-part approach to understanding and integrating the patient perspective and how it can guide study design and improve outcomes. Read and download the full blog https://lnkd.in/g59djn7n. Our dedicated team of Biotech experts will amplify your team’s expertise to help you uncover insights faster to impact patient lives. Let’s change lives together. #OncologyResearch #PatientPerspective #ClinicalTrials #ParexelBiotech
📢 Parexel is looking for talented professionals to make an impact in Regulatory Consulting. 🌎 Whether you're in Hyderabad, London or Buenos Aires, your regulatory affairs expertise will help us bring forward ground-breaking medical advancements to shape the future of healthcare. 🧭 Explore the possibilities at Parexel: https://insde.co/lph7 #RegulatoryAffairs #RegulatoryConsulting #ClinicalResearch
Navigating regulatory complexities in the European Union (EU) can be challenging for biotech developers. Three recent regulations require sponsors to follow new processes and have resulted in delays in initiating clinical trials: · Clinical Trial Regulation 536/2014 (EU-CTR) · Medical Devices Regulation 2017/745 (EU-MDR) · In Vitro Diagnostics Regulation 2017/746 (EU-IVDR) Though some companies may consider moving early-phase development out of the region, most therapies on a path to the global market will eventually need EMA approval. Biotechs who learn how to meet EU requirements now will be positioned for future success. Read our playbook on the current landscape of EU regulation, filled with sponsor perspectives and actionable strategies to plan for long-term success: https://lnkd.in/gTft9-jK #ParexelBiotech #Regulatory #EUCTR #EarlyPhase
At Parexel, we celebrate diversity and the power it brings to fuel innovation in clinical research! 🚀 Throughout June and July, our colleagues are participating in our internal "Show Your Colors" initiative, sharing photos of how they’re celebrating and supporting Pride at home or in the workplace. 🌈 Swipe through to see some of our favorite submissions so far. 👉 #PrideMonth #ParexelWithHeart Ayumi Goda Julie Stover Dana Beauvais
In this DIA Global interview, Parexel's Wyatt Gotbetter sits down with Johnson & Johnson's Kourtney Davis to discuss the impact of RWE on drug discovery, clinical research, regulatory decision-making and health equity. RWE is revolutionizing how we develop and bring drugs to market, complementing traditional clinical trials and improving patient care. 🩺https://lnkd.in/eJW_x475
Senior Director at Parexel, Head of Patient Inclusion
5dThanks for reading. What impact do you expect the updated guidance to have on patients, healthcare providers or industry?