Fireside Chat - Maximising your Sites Productivity & how to lessen the burden.
Sites are increasingly challenged with workload and resource constraints. This session will discuss ways in which to get the best output from sites.
- Addressing challenges, the sites are currently facing.
- An overview of the repercussions of such challenges, and a focus on what we can do to overcome them.
- Forward thinking to strengthen site output.
- Limitations with electronic applications
- Unravelling challenges of when sites are running multiple trials for the same indication or patient population
- Minimising study complexity to secure your site
- A look down the rabbit hole of increased site costs
Fireside Chat - Are Decentralised Clinical Trials still relevant?
- Was DCT just a COVID buzzword or does it still have practical applications?
- How can elements of decentralization be applied to clinical trials in order to maximize patient engagement?
- Does DCT still have a future in a post-COVID world or has the clinical trial industry returned to ‘normal’?Are there therapeutic areas where elements of decentralization or hybridization are essential to success? Where are the main technological and practical hurdles to DCT taking off?
The Pursuit of Success: Driving your drug from the lab to the patient
- Considering biotech’s limited funds
- Defining what do we do well & what could be improved – EU vs US focus
- Planning & preparation within clinical trials
- Choosing the right trial designs for new studies
- How to achieve successful launch by building an appropriate program
- Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly
RT: How do we apply GCP Compliance to Artificial Intelligence in Clinical Trials
Implementing effective vendor management tools and communication strategies to avoid the failure of clinical trials
Software as a Medical Device
Patient Engagement and Recruitment through Cooperation and Innovation
Political challenges beyond our control: How pharma and biotech companies in the US can mitigate against this
- Analysing global conflict’s impact on clinical trials within the US Pharma & Biotechs
- Assessing future trial design from a more resilient perspective
- Discussion on the higher plan of how regulators govern clinical trials and manage the rapid changes within the area, including what expectations the clinical trial ecosystem has for their regulators. Furthermore, discussions on how to strengthen the collaboration in the clinical trial ecosystem and what the clinical trial ecosystem would like to see from the governing bodies such as the FDA, and vice versa
Featured New Technology Presentation – CASE STUDY
Medical Device Trial Regulations, Quality, and Data Management.
Collaboration On Trial Design to Ensure Study Success
- Navigating collaboration & understanding between the AI experts and the Clinical Trial experts at design stage
- Understanding the complexities of a trial.
- Communication between study team and tech provider, to mitigate against possible failures before the start of the trial.
Overcoming Growing Scepticism of Industry Sponsored Research
- Transparency in our failures to avoid similar complications moving forward.
- Industry vs Government funding
Great expectations and how to meet them; How Technology is addressing Patient Reported Outcomes
- Connected devices and ePRO in clinical trials
- Digitalization and use of device data has endless opportunities to change the way we run trials
- Understanding your data collection is key – but how do we achieve the level of knowledge needed?
- Avoid expensive mistakes that undermine your trial outcome
- Focusing on design considerations
- Understanding the best framework for your study
- Considering patient ePRO assessments needed for a specific study
- Highlighting best practice for data collection
- US vs EU endpoints
Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
Legislation aiming to increase diversity in clinical trials which requires enhanced data reporting on clinical trial participant demographics.
- An overview of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
- What does a Diversity Plan look like?
- How are companies approaching the DAP process
- Determining the dynamic and strategy of such a plan
- Addressing the requirement to include information about the demographic diversity of the clinical trial population and address related issues
- Practical experience – submitting your diversity plan
Strategies to Develop Medical Device Clinical Trial Design
- Trial Design and Technology to Optimize Medical Device Trials
- Improving trial timelines
- Uncovering operational challenges of medical device trial design
- Best practices within medical device clinical trials in order to stay compliant
FIRESIDE CHAT - Conducting Real world studies efficiently with the objective of having high quality evidence
This session will discuss how Real-World studies can be conducted efficiently and with the objective of having high quality evidence.
- An overview of opportunities and challenges in working with RWD/RWE in Clinical Development
- Expanding the use of RWE by stakeholders
- Utilising tools to allow patients, investigators, and the wider clinical team to monitor progress and facilitate data from patients
- Using Real World Data in your clinical development program
- How we source & collect RWE
A New Age of Technology & Innovation: Ethical, Privacy, And Safety Considerations
- Collaborating With Digital Innovation: Data Security and Governance Under a New Age Of AI
- Finding the right balance between protecting data and enabling innovation
Regulatory Considerations and the use of Artificial Intelligence to Support Regulatory Decision
Sharing Best Practice for Improving Patient Enrolment, Retention, and Engagement for Successful Clinical Trials
- How to expedite enrolment through interface with sites
- Collaborating with patients to ensure patient-centric clinical trials and improved engagement
- Incorporating hybrid decentralized trials as a potential solution to decreased patient enrolment
- Understanding how much patients value the human touch to tend to their needs better
- Improving site engagement techniques
Protecting our planet: Sustainable drug development
- Understanding the environmental and social impacts of clinical trials
- Metrics for sustainability
- Collaborating with supplier ecosystems to drive sustainability goals
- Sustainability by design: innovation and changing behaviours
- Improving ways of working in the study design phase to reduce waste
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