In the final episode of the #ParexelBiotech podcast series, "De-Risking Drug Development," host Paul Bridges focuses in on post-launch market development and how to expand the use and value of your product over time. Exploring lifecycle optimization for biotech companies, Parexel experts Miriam Carr, Earl Sands, join David Hahn of The Medical Affairs Company (TMAC) to discuss the importance of planning as early as Phase 1-2 clinical trials and thinking globally from the outset. They discuss an alternative definition for target product potential (TPP) and the future possibilities and opportunities for products beyond initial approval. Our speakers close with one key piece of advice that biotech developers should – but often don’t – consider at this stage of the product lifecycle. Listen in now for valuable insights that can help you maximize the post-market success of your products: https://lnkd.in/g9s88n4P #Biotech #DrugDevelopment #TPP #ProductLifecycle
About us
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
- Website
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http://www.parexel.com
External link for Parexel
- Industry
- Pharmaceutical Manufacturing
- Company size
- 10,001+ employees
- Headquarters
- Durham, North Carolina
- Type
- Privately Held
- Specialties
- Regulatory and product development consulting, early phase clinical research, phase II-III clinical research, late phase clinical research, eClinical solutions, patient and site recruitment, medical device consulting, clinical research organization, pharmacovigilance, biotechnology, biotech, and market access
Locations
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Primary
2520 Meridian Pkwy
Durham, North Carolina 27713, US
Employees at Parexel
Updates
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📸 Click through for highlights from our time this week at World Drug Safety Congress Europe 🌟 👏 Sanjay Vyas, President, Safety & Logistics and Country Head of India at Parexel, shared a keynote on current and future practical implications of GenAI in pharmacovigilance. 👏 Kausik Maiti, MD, Executive Director, Safety Medical Sciences at Parexel, presented on the use of real-world data (RWD) for improved monitoring and evaluation of safety signals. Thank you to everyone who attended our presentations and stopped by our booth throughout this incredible week in Amsterdam! #WDSEU #WDSC #WDSEU2024 #WDSCEurope2024 #GenAI #Pharmacovigilance #RWD #DrugSafety
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⏰ The deadline for EU-CTR slim transitions is now just a few days away! After Oct. 16, submissions may be treated as full transitions, subject to Member States’ discretion. We strongly recommend that sponsors take advantage of the slim transition opportunity, which requires fewer documents than the full transition and may offer shorter timelines. Existing studies must be transitioned to the CTIS platform, even if there is uncertainty whether a study will still have active sites or patients in EEA countries after Jan. 31, 2025. However, if the end of the study is anticipated early next year, then sponsors could avoid substantial modification for alignment with EU-CTR requirements. This blog, prepared by Parexel's Esther Gil and Celina González-Colaço, shares actionable guidance for ensuring compliance with EU-CTR to maintain the validity of your clinical trials in the EEA. Get started before it's too late. Read now: https://lnkd.in/gzVsX254 #EUCTR #EEA #CTIS #RegulatoryCompliance #ClinicalTrials
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📊 Parexel's 2023 ESG Report: Our Approach to Sustainability 🌿 At Parexel, we're committed to delivering patient-guided solutions with a focus on operational excellence and integrated expertise across all phases of drug development. Our 2023 ESG Report highlights our multifaceted approach to ✔ Advancing equal opportunity for patients to participate in clinical trials ✔ Fostering diversity and inclusion ✔ Improving sustainability performance ✔ Strengthening governance practices. Find out how we've aligned our ESG priorities with global standards to create long-term value for stakeholders. Click through below for a preview or access the full report. 🔗https://lnkd.in/epnKawS9 #ESG #sustainability
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"Collecting real-world data (RWD) is integral to ensuring that underrepresented populations are included in drug development." In this edition of the New Medicines, Novel Insights newsletter, Karina D., Director, Scientific Real-World Data Strategy at Parexel, reviews how every patient interaction with a clinician, healthcare provider, or even medical device or sensor is an opportunity to capture valuable patient-specific data elements. Turn data elements into actionable information across studies with Karina's insights. Read the full article and subscribe to receive the latest #NovelInsights each week! #RWD #SDOH #PatientsFirst #Alzheimers #Neurology #Neuro #Neuroscience
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Parexel is proud to announce that Teri Karcher, Ph.D., has been named to the 2024 PharmaVoice 100 list of inspirational leaders in the life sciences industry! Teri was recognized for her innovative approach and significant efforts in forging new paths in the drug development paradigm — elevating Parexel’s site relationships to new levels of success and demonstrating an innate ability to lead with empathy and inspiration while maintaining a deep commitment to improving patient lives. Join us in congratulating Teri in the comments below and read what CEO Peyton Howell had to say in the press release. 👉 https://lnkd.in/ePqJxn3z #PharmaVoice100 #PV100 #LifeSciences #Pharma #PharmaLeaders
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As a dedicated clinical research professional with a strong commitment to patient safety, Inhye has found her niche at Parexel. In this Q&A she discusses her reasons for joining Parexel, shares how Parexel's corporate values align with her personal ethos and describes the collaborative atmosphere fostered by her colleagues. When she's not busy advancing healthcare, you might find Inhye: 🏃♀️ Staying active ☕ Exploring local coffee shops ❤️ Enjoying date nights with her husband. Curious about life at Parexel and the talented people behind our mission? Hear more from Inhye: https://insde.co/6298-2 #EmployeeSpotlight #LifeAtParexel #ClinicalResearch #ResearchNurse #Nursing
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Parexel Chief Information Officer, Jonathan Shough, joined Ben Fanning on Hexaware Technologies' CEO Tech Live podcast to discuss the evolving role of technology leaders in today's business landscape. Jonathan emphasizes the importance of navigating complexities through proactive planning and adaptability, particularly in the face of unexpected challenges: “Plan for the eventuality…how are we going to react to it? If you wait until you're in the suit, it's going to be really difficult." Listen to the full episode for Jonathan's insights on leadership and stay tuned for the video interview! https://lnkd.in/dZK-2K3R #ChampionsofChange #CEOTechLive #PoweredByHexaware #ClinicalTrials
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📣 We're thrilled to announce Parexel is a finalist for "Best Contract Research Organization" at the 3rd annual Citeline Japan Awards! The #CitelineJapan Awards celebrate outstanding innovations in Japanese pharma and biotech, highlighting Japan's crucial role in global healthcare. This nomination underscores Parexel's commitment to advancing clinical research and drug development in Japan and we're honored to be recognized among the leading innovators in our field. Winners will be announced Oct. 22 in Tokyo. Stay tuned for the results! https://lnkd.in/gqNyeeBd 📣 パレクセルが第3回サイトライン・ジャパン・アワードの「Best Contract Research Organization」のファイナリストに選ばれたことをお知らせします! サイトライン・ジャパン・アワード #CitelineJapan Awardsは、日本の製薬およびバイオテクノロジーにおける卓越したイノベーションを称え、世界のヘルスケアにおける日本の重要な役割をハイライトするものです。今回のノミネートは、日本における臨床研究と医薬品開発の推進に対するパレクセル社のコミットメントを裏付けるものであり、この分野における主要なイノベーターの一社として評価されたことを光栄に思います。 受賞企業は10月22日に東京で発表されます!https://lnkd.in/gqNyeeBd #CitelineAwards #ClinicalResearch
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Be sure to tune in to a special edition of the #BioCenturyThisWeek podcast. Our own Gwyn Bebb, SVP, Global Therapeutic Area Head - Oncology, shares his insights coming out of #ESMO24, reflecting on the transformative journey of immunotherapy over the past decade, the promising future of mRNA vaccines in cancer treatment and the innovative strides in radiopharmaceuticals. 🌟 Don't miss this engaging conversation that bridges the worlds of oncology and innovation. https://lnkd.in/gEtXqAHf #BioCenturyPodcast #Oncology #CancerResearch #ClinicalTrials
On a special edition of the #BioCenturyThisWeek podcast, Gwyn Bebb, SVP and global franchise head for oncology at Parexel, shares insights on the evolution of immunotherapies and COVID vaccines’ potential to treat cancer. BioCentury's Lauren Martz and Stephen Hansen also discuss key takeaways from #ESMO24, including data for ITeos' TIGIT blocker and Johnson & Johnson's Rybrevant. Tune in on your favorite podcast platform: https://lnkd.in/gqaV4-aB