Contact us Delivering with heart... Parexel has the experts, innovations and processes in place to navigate the new and rapidly changing landscape while keeping the patient at the heart of everything we do. Learn more in this letter from our CEO Jamie Macdonald. Read the full letter from our CEO HOMECOVID-19 WEBINARS & BLOGS Featured COVID-19 Webinars Empowering Clinical Trial Sponsors in a COVID-19 World Patients can’t wait: Advancing Rare Disease & Oncology drug development during COVID-19 28 July 2020 This virtual roundtable will explore the challenges and opportunities facing companies developing oncology and rare disease products during COVID-19. Parexel will be joined by Sara’s Cure, a Clear Cell Sarcoma patient advocacy group and charitable foundation to share patient perspectives of participating in research during the pandemic. Watch on demand Mitigating risks to ongoing clinical trials in the current COVID-19 environment 28 May and 3 June 2020 The clinical development journey is fraught with pitfalls and roadblocks; COVID-19 has almost overnight added to the complexity. Innovations, technologies and reinvented processes can help. Our experienced team of experts shares experiences, lessons learned and tips to help you mitigate risk in the current environment while implementing some of the industry’s latest innovations. Watch on demand Optimizing study design. Addressing the need for real-time data for emerging COVID-19 therapies 21 May and 27 May 2020 Now more than ever, companies may need to consider agile and novel evidence generating study designs to streamline development. This webinar analyzes the role that Real-World Evidence (RWE) plays in supporting the urgent need for evidence on emerging therapies for COVID-19. Watch on demand Under Siege: Challenges and Mitigation Strategies for Clinical Trial Conduct During the COVID-19 Pandemic with Respect to Data Integrity 15 June and 16 June 2020 During the current COVID-19 pandemic, regulatory and compliance risk is an acute concern by health authorities, pharmaceutical manufacturers, medical practitioners and patients. This webinar will discuss the challenges and potential mitigation strategies, in accordance with appropriate application of regulations and COVID-19 guidance documents, to ensure GCP compliance with respect to managing lost to follow-up and missing data. Watch on demand Fast Start-up of Vaccine Studies for COVID-19 6 May and 13 May 2020 With the evolving situation of COVID-19, companies are rushing to get new vaccines to patients and bring this outbreak to a close. Join Parexel’s experts as they draw on vaccine experience and learnings, sharing tips and considerations for the fast start-up of new trials. Watch on demand Learnings from China: Clinical Studies During and Post the COVID-19 Pandemic 23 April and 29 April 2020 Join Parexel experts as they discuss lessons learned over the past three months in managing COVID-19’s impact on trials in China. Our panel will provide insights into what companies should be doing now to prepare for the upcoming ‘new normal’. Watch on demand Related Webinars Remdesivir for COVID-19: Case Study and Clinical Trial Design 16 July 2020 The preclinical profile of Remdesivir supported its further development as an antiviral for COVID-19. Listen to a panel discussion on how they optimized site selection and the challenges they faced with trial strategy and design. They will also review the clinical trial results of Remdesivir in patients with SARS-CoV-2 infection, address current gaps in knowledge, and share recommendations about appropriate use of remdesivir in the context of the ongoing global pandemic and limited drug supply. Watch on demand Transitioning Clinical Studies from Traditional to Decentralized: An Operational and Regulatory Perspective 19 May and 26 May 2020 Given the unprecedented global health situation, we are seeing a swift change in attitude towards Decentralized Clinical Trials (DCTs) – both fully virtual and hybrid approaches. This is particularly true from a regulatory perspective, where new guidance is coming out with a number of agencies proactively stating their preference for a DCT approach to support patients. In this webinar, Parexel experts will explore what these changes mean for ongoing traditional trials. Watch on demand Watch on demand (APAC) Beyond COVID-19: The New Normal in Risk Based Monitoring and Quality Management 12 May and 20 May 2020 Please join this webinar to learn first-hand how the Parexel and CluePoints partnership is driving best in class Risk-Based Quality Management strategies to support clinical development. This session will focus on how early risk detection can be leveraged to detect issues across your trial and ensure operational excellence. We believe the challenge of identifying and actioning these critical issues in a timely manner will be the catalyst in driving the adoption of central / remote monitoring going forward. Watch on demand Watch on demand (APAC) Fireside Chat: The Future of Clinical Trials and Site Engagement 16 July 2020 In this conversation, Gadi Saarony, CEO of Advarra, speaks with Deb Tatton, Senior Vice President, Global Clinical Operations at Parexel. Gadi and Deb will talk about the challenges sites face, bring awareness to these issues, and propose possible ways sponsors and CROs can work more collaboratively with sites to improve study startup and address the changing clinical trial landscape. Register now FSP and COVID-19: Impact on Clinical Trial Development 23rd June 2020, 12:00 PM ET Functional service provider (FSP) models, designed to help sponsors efficiently and cost-effectively manage workforce needs across clinical portfolios, can be a strategic asset during the coronavirus pandemic. Experts representing monitoring, data operations and safety will discuss how FSP models can often work better than traditional approaches when managing unexpected circumstances. Discussion will also include current COVID-19 examples to illustrate speed and execution flexibility. Watch on demand Regulatory Reliance and Desktop Inspections: The New Normal? 24th June 2020, 3:00 pm IST Former FDA and MHRA regulators will discuss how regulators are needing to employ desk-top inspection programs during the pandemic and also for the foreseeable future. They will also explain how Regulators are utilizing greater reliance on the work of other Regulators, and will also present on some key considerations to take to prepare your company for a desk-top inspection. Watch on demand Global New Drug Development, Supply Chain Compliance & Design Strategy Under COVID-19 21 April 2020 Speakers will discuss the strategy to consider under COVID-19 situation for new drug development, including regulatory, trial design and supply train perspectives. Details and registration information are in Chinese. Watch on demand Recent COVID-19 Blogs What COVID Taught Us About Focus, Innovation, and Leadership 09.24.21 - Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry… RBQM is our future: Using holistic risk-based oversight, we can focus on a trial’s most critical factors 06.18.21 - Recently, RBQM experts offered ideas of what’s ahead. RBQMLive, hosted by CluePoints, featured 18 industry leaders and… Decentralized Trials: Considerations for Building a New Patient-Centric Model 05.13.21 - During the past year, patients around the world waiting for new treatments have taken heart that clinical trials have been… On the precipice of an impending avalanche of regulatory compliance activity: Are you prepared? 03.15.21 - The COVID-19 pandemic brought into sharp focus the vulnerabilities in supply chains for medical products and the importance… Challenges of 2020: Lessons for Clinical Trials in Diabetes 11.23.20 - The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have… How COVID-19 Testing Demand Threw off Thermo Fisher’s Acquisition of Qiagen — From the HealthAdvances.com blog 09.18.20 - About the Authors Aaron Dy, Ph.D. is a Senior Analyst in the Health Advances... See more Parexel COVID-19 Resource Center Your central place to rapidly access latest news, translated guidance information, and expert interpretations from our former regulators related to COVID-19. Stay informed in our Resource Center Decentralized Clinical Trials The future of clinical trials is now Learn how we guide you through all aspects of planning, operationalizing, and safely deploying Decentralized Clinical Trials. Download the new brochure CORPORATE LINKS About Us News Events Careers Education Investigators My Preferences Global Locations SOLUTIONS Parexel Biotech Clinical Development Consulting Medical Affairs Real-World Evidence FSP STUDIES & VOLUNTEERS About Trials Participate in a Trial GLOBAL STUDY LOCATIONS Baltimore, US Los Angeles, US London, UK Berlin, DE 275 Grove St., Suite 101C, Newton, MA 02466 +1 617 454 9300 2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713 +1 919 544 3170 © 2000-2021. Parexel International Corporation. 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