Blockchain – Is the Biggest Buzzword in Technology the Best Weapon Against Counterfeit Drugs?
Blockchain is often pointed to as one of the new technologies most likely to revolutionize clinical trials supply – but how useful could it be in tackling counterfeit drugs:
- With the counterfeit drugs market being worth an estimated $200 billion, what is the role Blockchain can play in combatting counterfeit drugs and tracking product authenticity?
- How likely is it that governments will introduce new regulations in regards to labelling and tracking products throughout the supply chain – and what role can Blockchain play in this
- Is the cost of setting up Blockchain worth it in your company? What are the alternatives?
- A quick review of real world evidence in regards to Blockchain – how it has been successfully used in supply chain management and the lessons learnt from this
How We Did It: Getting Device Approval Through the FDA’s Breakthrough Devices Program
- A review of what the FDA Breakthrough Devices Program is
- How we got approval and a walkthrough of the approval process
- Lessons learnt and the benefits of this program
- What companies need to know when seeking approval in the US through this route – could this be the right program for your device?
CASE STUDY: Company Expansion: Handling the Growing Pains
We welcome X from X to discuss how they expanded their company and overcame the associated challenges.
- Translating your company into a larger business when you only have a small workforce – do you outsource to cover processes that can no longer be dealt with in house?
- Discussing and debating at what stage you should look to step up your workforce and invest in expansion
- Surprises and challenges that arose when expanding the company – and how these were overcome
- Discussing the solution providers that helped with the expansion process – how to make the decision on what help to bring in
Working with a Smaller, Niche Supplier: Can this be the right option for your trial?
- Benefits and opportunities that can come with working with a smaller niche supplier on your trial – and how this compares to working with a large CRO
- Identifying the pitfalls and challenges that come with working with a smaller supplier – what questions do you need to ask to ensure they can adequately cover your needs?
- How can we mitigate and minimise the risk that something could go wrong when relying on one small supplier – tips and tricks
- Exploring ways to look into the backgrounds of your small supplier – how to best get reliable information on the reputation of a small supplier. Where is the best place to go to for recommendations on a supplier whose advice can we most trust?
ROUNDTABLE: Starting Over: How to Recognise When Trial Protocols Need to be Redone
Recognising that your trial protocols aren’t working is a difficult thing to do. Join this group to discuss red flags and key signs that could indicate that a trial needs to be abandoned and restarted with new protocols.
Moving Forward for Rare Disease Studies: Are Decentralized and Virtual Trials a Permanent Solution?
- Getting your trial back on track post- COVID-19: are remote solutions the way forward?
- Weighing up the pros and cons of virtual and decentralized trials for rare disease studies
- Considerations needed for a rare-disease specific remote trial
- How a virtual trial can benefit the rare disease patient
A Fresh Look at Patient Recruitment Focusing on the Top of the Funnel – Is Our Image the Problem?
This talk will focus on why we should be looking at the top of the patient recruitment funnel – why we should be targeting patients before they have even thought about joining our study – in order to more successfully recruit for trials. This new approach is vital as studies show we are failing at efficiently engaging patients – some experts claim we are still only reaching 10% of our potential pool of patients.
- Strategies for changing the public’s perception of clinical trials and how this can benefit all of us
- How we should be using social media and other tools to engage with your potential audience and encourage them to see you in a positive light
- What we can learn from the oil and gas industries – why are we seen as ‘greedier’ than them?!
Electronic Informed Consent: The First Thing to Introduce for a Modern, Streamlined Study
While they may be flashy, technologies such as DCTs, wearables, Machine Learning and blockchain can be expensive, hard to learn and difficult to immediately integrate into most studies. However there are other technologies you can invest in such as Electronic Informed Consent that can position you as a modern, future-ready institution.
- An overview of Electronic Informed Consent and how it can be quicker and easier in the long run to implement an electronic system
- Facing up to the challenges in implementation such as adhering to regulations over different regions and developing a platform
- Exploring the impact on patient engagement – will it really lead to easier recruitment and fewer patient dropouts?
- How the pandemic has streamlined the adoption of virtual solutions for patient consent and the benefits this has had
Conducting Trials in North Africa and The Middle East: Key Considerations and Best Practices
In this session, we welcome X to break down the various challenges and benefits that come with expanding into emerging markets in North Africa and the Middle East.
This session will cover:
- Regulatory considerations – exploring what US companies need to be aware of before submitting a trial in these territories
- Unpacking the cultural differences and taking a realistic look into how this could impact your trial protocol and design
- Exploring the benefits such as large, treatment naïve populations, lower costs etc.
- The other side of the coin: downsides that need to be taken into consideration such as a lack of infrastructure, slower regulatory processes etc.
Launching Your First Clinical Trial: Top Tips and Lessons Learnt
- Advice on vendor negotiation and management – how to ensure you are working with a partner who can cater to your specific trial needs
- Staying on budget and sticking to timelines: advice on how this can be done
- Exploring governance and risk control – ensuring you remain in control of all aspects of your trial
- Lessons learnt: what advice should be passed on to a first time trial manager
Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations
- Starting off strong: What you need to know before launching your rare disease trial
- Change your mindset: how rare diseases require a much more individual approach to patient recruitment
- Preparing for your study: ensuring you have understood the impact on patients and their caregivers
- Finding the right vendor partner: how to ensure your CRO can handle a rare disease trial
The Single Most Important Technology You Can Have: Cybersecurity
With many of us turning to remote monitoring and virtual at home data tracking solutions – how can we ensure this data is accurate and secure?
- The argument that cybersecurity is the single most important investment your company can make – and why it is that so many companies are ignoring the issue and failing to adequately protect their data
- Data breaches and cyberattacks – how to remain vigilant at all stages
- Exploring how you cannot innovate other areas of your supply chain with wearables, AI, virtual site visits etc if your data protection and cybersecurity is not adequate
Back
