🎙️ Looking for your next listen on your commute home? Tune in for insights from Parexel's Cris McDavid on the latest ACRO Good Clinical Podcast! As Director of Global Clinical Operations for RBQM, Cris shares expertise on moving beyond the "belt and suspenders" approach in clinical data quality. Listen below for a sneak peek. 👇 👀 Don’t miss Cris and other industry experts as they analyze five years of RBM/RBQM adoption data and what it means for the future of clinical research. Access the full episode: https://lnkd.in/gdMz_agR #ClinicalResearch #RBQM #ACRO #GoodClinicalPodcast
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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Attention site partners, tomorrow is the last day to vote for the 2024 Society for Clinical Research Sites (SCRS) Eagle Award. Your vote is important to us, and we appreciate your partnership in driving meaningful change in clinical research. As an example of our commitment, check out the second episode of our "Enabling Successful Sites" series exploring how to better empower sites with the tools and training necessary to recruit diverse patient populations successfully. 💡 🎙️ This episode features an insightful discussion with: 🔹 Karen McIntyre, Vice President, Global Site Alliances 🔹 Xoli Belgrave, Senior Director, Head of Clinical Trial Diversity and Inclusion 🔹 Jamie Langley, Executive Director, Parexel Academy 🔹 Dr. Lovie Negrin, CEO and Founder of Randomize Now Tune in now and be part of the movement toward greater diversity, equity and inclusion in our industry! 🎧✨ https://lnkd.in/eXSbCSSd And don't forget to cast your vote here for the 2024 Eagle Award https://lnkd.in/eP6pKMp4 #ClinicalResearch #SitePartnerships #SuccessfulSites #EagleAward
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FDA expedited designation trends are a marker of innovation, promise, and momentum in the R&D pipeline, particularly for cutting-edge therapies. 🆕📈 In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Cell & Gene Therapy Center of Excellence explores the latest trends in FDA expedited development designations for advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER), focusing on the three most recognizable regulatory designations available to innovative and novel products. Explore recent expedited development investigational products - and the supporting evidence used to attain these FDA designations. Read the full analysis and subscribe to receive the latest #NovelInsights from our thought leaders every week! #ParexelBiotech #FDA #CellTherapy #CBER
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Parexel today announced the release of its 2023 Environmental, Social and Governance ("ESG") Report. The ESG Report is part of Parexel’s annual commitment to disclose and communicate the progress of its sustainability priorities, underscoring the company’s core values of putting Patients First and delivering With Heart™. "Our ESG progress in 2023 reflects our ongoing commitment to making a positive impact on the world around us by integrating sustainable, ethical practices into and across our business and our care for patients to transform the future of medicine,” - Peyton Howell, Chief Executive Officer. Click through for highlights of the company’s progress or access the press release and report here: https://lnkd.in/eeVMrbYA
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This #DisabilityPrideMonth we celebrate the resilience, achievements and diversity of our colleagues in the disability community. 💪 More than 30 colleagues from around the globe serve on ParAbility, our Disability Steering Committee, sharing perspectives and providing leadership on issues impacting the disabled community. They help drive the actions Parexel can take as a company to become the model of inclusivity — in our industry and beyond. ParAbility is committed to: 🌈 Providing strategic recommendations aligned with organizational strategy, ensuring inclusivity at all levels. 🌈 Leading initiatives such as office accessibility audits, training programs and establishing feedback mechanisms for continuous improvement. 🌈 Emphasizing the importance of inclusive language and understanding diverse perspectives within the disability community. At Parexel, ParAbility is leading the way in fostering an accommodating workplace where everyone can thrive. #DisabilityPride #Inclusion #ProudToBeParexel
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🌟 Exciting insights from our passionate Infectious Disease team ahead of World Hepatitis Day! 🌟 Anne Kasmar MD MSc reminds us to engage with all stakeholders early for sustained and productive partnership on the scientific frontier as we push the boundaries of science to find a cure for Hepatitis B. Roger Inouye acknowledges the global impact of Hep B, and Xoli Belgrave emphasizes the importance of patient collaboration in our journey towards a cure. Join us in our commitment to advance research and bring hope to millions. Together, we can conquer Hepatitis B! https://lnkd.in/gHaUdbeq #WorldHepatitisDay #PatientsFirst #InnovateToCure
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The site feasibility and initiation process often poses significant challenges for investigative sites. In our recent poll, we asked for your insights on what aspects of this process need the most urgent attention. Here are the results: 🏠 Almost half (54%) of respondents indicated that the length of questionnaires needs to be addressed. 📢 30% believe more precise recruitment forecasts are needed. 💻 13% want the industry to provide clearer criteria and timelines. As part of our new podcast series, “Enabling Successful Sites,” our VP of Global Site Alliances, Karen McIntyre MSc Clinical Trials, and VP of Launch Excellence, Marta León Montagut, talked to Mohammad A. Millwala, CEO of DM Clinical Research, to better understand these challenges and offer solutions to improve the feasibility and study start-up process for investigative sites. Listen to the first episode here➡: https://lnkd.in/dy5B9CkS #ClinicalResearch #SitePartnerships #StudyStartUp
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In the latest episode of the #ParexelBiotech podcast series, “De-Risking Drug Development,” our host, Paul Bridges, and colleagues focus on critical decision points in phases IIb & III that can ultimately determine the success of your product. Join Sangeeta Budhia, Sinan B. Sarac (MD, MSc, PhD), and Amy Pace as they discuss how to accelerate development and opportunities to differentiate your product through innovative and adaptive trial designs. Learn about the importance of integrated evidence planning and the critical role of early value story development alongside target product profile (TPP) planning. Mitigate development risks and stand out among competitors by planning ahead. Listen here: https://lnkd.in/g9Kt5hGA #Biotech #TrialDesign #ClinicalDevelopment
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The site feasibility and initiation process can be a frustrating one for investigative sites due to lengthy questionnaires, duplication in data requests and unrealistic recruitment targets and start-up timelines. Which do you believe should be the highest priority? #ClinicalResearch #SitePartnerships #StudyStartUp
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The FDA is no longer recommending a repeated switch study to demonstrate interchangeability of biosimilars ❗❗ In this edition of the New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory
New Medicines, Novel Insights: New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US
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