Parexel

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

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

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 

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 Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability.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 

The Foundation Fighting Blindness — one of our 2024 Corporate Patient Advocacy Partners — has been a driving force in the global development of treatments and cures for blinding diseases for more than 50 years! 🔷 When the Foundation was established in 1971, knowledge of blinding diseases and clinical trials for potential treatments were non-existent. 🔷 Through fundraising, the Foundation has helped launch more than 45 clinical trials for potential treatments for blinding diseases. 🔷 The Foundation’s Scientific Advisory Board (SAB) is comprised of the world’s leading retinal experts who provide insight on research and clinical advancements and review research grant applications. We’re proud to partner with the Foundation this year to leverage ophthalmology patients’ first-hand experiences and insights to improve clinical trial accessibility and enhance the trial experience. Learn more about their work: https://lnkd.in/eysfKJj #PatientAdvocacy #FightBlindness {Image Description} Video shows an image of 3 professionals (2 women, 1 man) around a conference table with the text "2024 Corporate Patient Advocacy Group Spotlight." One woman has a prosthesis. The second slide shows the blue and white Foundation Fighting Blindness logo on a black background. The third slide has white text on a black background: "Committed to finding treatments and cures for people affected by blinding diseases.

Spotlight on 📣 Parexel's Bucharest Office! 📣 Nestled in the heart of Romania's capital, our Bucharest team works from the stunning Metropolis Center ─ originally built at the end of the 19th century as a printing house. Refurbished last year, this unique office space beautifully blends historic architectural elements with modern functionality and offers state-of-the-art facilities designed to promote collaboration. 🏢 🤝 We're proud to be part of Bucharest's rich tapestry, contributing to its status as a major cultural and economic hub. Our office honors the city’s heritage while embracing the future. Click through to explore. ➡ #LifeatParexel #OfficeSpotlight 

At Parexel, we believe disability inclusion drives #innovation. 🚀 We're excited to share that we've earned a top score on the Disability Equality Index® and have been recognized as a "Best Place to Work for Disability Inclusion" by Disability:IN!   A special shout-out to Aida Sabo (She, Her, Hers) and David Dent MBE, MBA, CMgr, CCMI, FIoD, who were on hand to accept our recognition at the Disability:IN conference. We're proud of the work they and other Parexel leaders have done in partnership with our Par-Ability Committee. Despite our progress there is work still to do and we're committed to continuing to drive more inclusive initiatives. 💪   Learn more about the Disability Equality Index — which has become the leading independent, third-party resource for the annual benchmarking of corporate disability inclusion policies and programs: https://lnkd.in/e66Chtj #DisabilityPrideMonth #AreYouIN #BestPlaceToWork24

We’ve listened to the feedback and made a few upgrades! 🎉✨ A new look, with the same industry-leading insights, strategies, and updates advancing global clinical research. The New Medicines, Novel Insights newsletter will now be available on a weekly schedule, with focuses valid for drug development companies of every size! This week from #ParexelBiotech, Dr. Gwyn Bebb and former regulator Steve Winitsky, M.D. explore how bringing CAR-T therapy to community-based sites can enhance accessibility, equity, and patient outcomes. Learn how community-based treatment centers are breaking barriers and discover the checklist for evaluating readiness. Read how industry experts are working towards inclusive and comprehensive cancer care for all. Access the full article below and subscribe to receive weekly #NovelInsights direct to your inbox! #CellTherapy #GeneTherapy #Oncology #ClinicalResearch

July is Disability Pride Month, and we’re celebrating the contributions and experiences of individuals in the disability community. 🌈 To this end and as part of our commitment to inclusive clinical research, we launched our inaugural Ophthalmology Patient Advisory Councils to better understand and improve the accessibility of trials for patients in the Ophthalmology community.   Recent meetings focused on inherited retinal diseases and Usher Syndrome, with insightful discussions on the importance of:   🔸 Raising awareness of clinical trials for patients with blinding diseases, the vital role care partners play and the support services needed to facilitate participation in trials.   🔸 Using communication aids to increase healthcare accessibility for the Usher Syndrome community and exploration of better ways to communicate consent in clinical research.   A huge thank you to Foundation Fighting Blindness — one of our 2024 Corporate Patient Advocacy Partners — for working closely with Parexel to connect with patients and care partners who provide invaluable personal insights to our councils. 🩺 🌍

📣 We're thrilled to announce our "Next Generation" Site Scholarship program, exclusively for emerging investigative sites! The scholarships will provide support and resources to help emerging sites ─ the next generation of clinical research ─ reach the next level. 🚀 Each of our 10 scholarship recipients will receive 🔹 A one-year SCRS membership with online training 🔹 Mentoring sessions with experienced sites in our Site Alliance Program 🔹 A dedicated Parexel Site Alliance Manager 🔹 One complimentary pass to the 2024 SCRS Global Site Solutions Summit. Don't miss this opportunity to accelerate your site's success! Apply today: https://lnkd.in/e_bpyVnx