Accelerating clinical trials takes on special urgency in oncology. Martin Roessner explains how Parexel Biotech is advancing innovative approaches to optimize study design and streamline protocols. He shares that the more flexible the study, the more complex it is. However, even in the case of a biotech company with limited capital, a flexible trial design could confirm efficacy and safety as an early milestone and potentially lead to a second round of financing. Read the full article and be sure to follow the rest of this oncology blog series: https://lnkd.in/gRPwG6EE Learn more about how our dedicated team of Biotech experts will amplify your team's expertise to help you uncover insights faster. #ClinicalResearch #Biotech #Innovation #Oncology #ParexelBiotech
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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The analysis of large published literature to gather safety and efficacy information on medical products is critical for compliance and patient safety. This week, we spoke with Pallavi Rehal, Director of Pharmacovigilance Operations at Parexel, about how #AI is supporting her team’s efforts in safety services. Click through to read her opinions on artificial intelligence in clinical research in the latest edition of our #AIandMe series. Share your experiences below! #Pharmacovigilance #ArtificialIntelligence #MachineLearning #DrugSafety
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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
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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
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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
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Parexel reposted this
Let's talk about the long-awaited update to the FDA guidelines on diversifying patient enrollment... #parexel #ACRO #withheart #patientsfirst #FDA #allpatients
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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
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Parexel on LinkedIn
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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
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📢 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
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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