Delivering with heart...

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.

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.

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.

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. 

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’.

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.

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.

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.

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.

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.

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.

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.