This session will discuss and address the impact that COVID-19 has had on clinical trial budgets, including site contracting considerations, site initiation processes, remote monitoring versus face-to-face monitoring visits, virtual meetings requirements, and vendor requirements.

Identifying trends in site payments during the pandemic to better inform upstream forecasting, budget creation, and set realistic expectations between key stakeholders in study start-up.

We'll discuss key trends to help support informed upstream decision making, including:

Sponsors continue to operate under compressed timelines and there is a need to speed up negotiation timelines.  One of the bottlenecks is the timely negotiation of clinical site budgets.  In this session we will discuss the advantages and disadvantages of negotiating site budget by visit versus procedure.  

Investigator payments continue to be one of the most pressing and enduring clinical operations challenges. More than one year after implementing an automated solution in the US, Bayer has expanded to six countries with 13 more planned for 2021. Bayer will discuss the implementation process for the expansion, the challenges and lessons learned, and why managing expectations with your vendor is so important.

COVID-19 has forced manufacturers to rethink trial timelines and speed up vaccine and drug development, without compromising on safety and quality. They must be equipped with technology and processes that not only automate core budgeting, contracting and forecasting processes, but also enable business agility and accelerate execution. In this session, we’ll explore clinical research contracting solutions that are essential to achieve efficiency and be prepared for the uncertainties of tomorrow. 

The rise of a highly-contagious COVID-19 variant has highlighted the importance of developing vaccines that induce broadly reactive antibodies capable of offering potential for protection from mutated strains of COVID-19 that may continue to emerge over time. The challenge the industry is facing is not only prioritizing how to end the ongoing pandemic, but also how to optimize vaccines for long-term protection against coronaviruses. With the goal of developing vaccines that add meaningful clinical benefit to the group already approved, VBI is progressing two vaccine candidates – a monovalent COVID-19 candidate and a trivalent broad-spectrum coronavirus candidate, which in preclinical studies induced reactive antibodies against COVID-19, SARS, MERS, and a seasonal variant HCoV-OC43. 

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

The COVID-19 pandemic is disrupting clinical research in most of the world, with immediate impact on clinical trials monitoring practices due to challenges coming from the travel bans, restrictions/social distancing and shifting operations to work remotely, etc. These factors have also translated into issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks in clinical trials conduct due to COVID-19. Remote monitoring should be based on risk assessments as a continuous and living process as the situation evolves over the coming weeks to months. Routine and ongoing cross checks for study teams are already proving an alignment on key timelines, critical risk points and other study specific challenges as we are moving towards de-centralized settings in the conduct of clinical trials. We have analyzed lessons learned and attempted to develop best practices to mitigate risks and adjust clinical research operations in this unprecedented time.

One of the pillars to a successful trial is data management. The data management workflows have been manual in many aspects including review, cleaning, oversight and reporting heavily reliant on Excel. RBQM concepts, including quality by design, risk-based approaches, automation and aggregation, and transparent reporting can be applied to these workflows, bringing substantial improvement to processes, collaboration and oversight.

As we entered a new normal at the tail end of COVID-19, we took lessons learned from the experience and applied them to how we continue to conduct clinical trials to produce new therapies for the patients we serve. We needed to look beyond the pandemic to design and plan resilient clinical trials with the ability to withstand future pandemics and mitigate some of these key challenges. During this session, the panel will discuss some of the ways we examined and implemented a better way to do clinical trials from concept through conclusion. 

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.