Outsourcing in Clinical Trials UK and Ireland 2023

• An overview of proposals for the UK’s clinical trial legislation designed to make the UK the best place to research and develop safe and innovative medicines
• Results from the MHRA’s consultation: feedback on proposals
• What the new clinical trial legislation will mean for the future of clinical trials in the UK

The new myMedidata app launches with further integrations of key Medidata technologies in pursuit of a better and more flexible patient experience. Join this session to learn more about the latest developments in eCOA to strengthen decentralized clinical trials with features such as image capture. This provides patients with the ability to capture photos from any device in any location from any location on a secure and compliant platform. See how these updates can be leveraged to improve patient experiences while also streamlining data capture for your trials.

• Understanding MHRA orphan designation and how this differs from EMA regulations
• How can orphan drug status from the MHRA support clinical development for rare diseases?
• Navigating hurdles around data and evidence for studies with smaller numbers of patients
• Ensuring early access to drugs and how to make sure drugs are both safe and quickly available to the British market

• Regulatory and ethics strategy and tactics
• Hospital site set-up
• Onsite monitoring

Chair: Reynald Castañeda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

• How easy is it to incorporate remote monitoring and wearables into your clinical trial?
• Working constructively with patients and advocacy groups to ensure your trial is accessible and patient focused
• Is decentralisation always best for patients? Considering hybrid trials as a means to cater to all patient needs
• Beyond just pandemic crisis management: what is next for virtual, remote and decentralised clinical trials in the UK and Ireland?

MODERATOR:

Reynald Castañeda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

PANELLISTS:

Krzysztof Potempa, Founder and Chief Executive Officer, Braincures

Suki Malhi, Senior Director, Clinical Affairs, Oakhill Bio

• Why is there still hesitancy in the adoption of Bring-Your-Own-Device (BYOD) to capture electronic Patient-reported outcomes (ePROs) in clinical trials?
• Have PRO endpoints captured using BYOD been successfully submitted to regulatory bodies and used for labeling?
• A call to action: pledge your intention to contribute to a database of PRO endpoints captured via BYOD used in medical product labeling
• Are the concerns around BYOD as compared to provisioned devices and paper justified?
• The importance of a considered approach to BYOD in your clinical trials; ensuring controlled flexibility to foster patient centricity
• What is the role of BYOD in traditional, hybrid, and decentralised clinical trials?

• Balancing degree of oversight over your CRO: how involved should you be?
• Looking at how trial sponsors can maintain good outsourcing partnerships
• Aligning vendor and sponsor teams under one shared goal to deliver your trial smoothly and efficiently

• Why eCOA is an important part of your trial design
• Why patient insights are key to both trial design and your eCOA strategy
• Why it is important to ensure that the right eCOA are selected for your study population by identifying the unique challenges of rare disease and oncology patient populations
• Highlight the lessons learned from COVID and how we can define a new norm for research which puts the participants at the center
• How your eCOA strategy needs to focus on the global perspective and to ensure inclusivity
• Why it is important to monitor your eCOA compliance and identify triggers early so that sites can be active partners in the study

• End to end trial coverage without an exorbitant price tag: how to budget and keep costs minimal
• Creating and building a network of external support to run your clinical trial
• Key lessons learned: what would we have done differently?

• Decentralised clinical trials are becoming the new norm, but let’s consider the impact on every step of the clinical workflow
• Digitisation and decentralisation go hand in hand, but does this approach lead to the “consumerisation” of clinical trials and redefine how patients engage with providers?
• The characteristics of decentralised clinical trials present multiple supply chain challenges: is collaboration the solution to these challenges and importantly, are they worth rising to?

• What constitutes a good sponsor-CRO relationship?
• Handling communications with CROs in situations where you have never met face to face: what can you do to make the relationship easier?
• Considerations when choosing a CRO in order to facilitate a strong partnership
• Remote communications: best practice for selecting and working with a CRO when working remotely

• We welcome Pierre Morgan to present this case study style discussion focussing on the commercialisation of a vaccine. The aim of this talk will be to take a realistic look at what is needed for commercialisation so you can plan accordingly.
• Technology impact on scalability and manufacturing lead times
• Evaluating technical feasibility and regulatory acceptability of technology transfers to localize production
• Assessing demand to right-size supply and adjust delivery schedule
• Managing affordability for buyers and corporate profitability objectives through pricing and advanced commitments

• Key factors driving the growth in the world’s fastest growing region for clinical development
• Decentralised clinical trials in APAC current landscape and future expectations
• Cutting edge technologies and considerations when planning for success

Chair: James Rudge, Technical Director, Neoteryx

• Why are racial and ethnic minorities often underrepresented in clinical trials?
• Methods to engage minority communities and demographics who might not usually participate in clinical trials
• Utilising social media as part of patient recruitment

• How are hybrid trials defined
• What are hybrid technologies
• How hybrid benefits your trials
• Disruptive technologies

Learn how elluminate delivers:

• Operational analytics including enrollment, protocol compliance and safety
• Risk-based analyses and insights with elluminate RBQM
• Operational knowledge for data-driven development with elluminate CTMS
• Centralized issue management across roles in operations, data and medical review
• Sample tracking, data forecasting and financial performance indicators

• An overview of the process of designing a decentralised trial for the first time
• Regulatory challenges in the UK when it comes to decentralised trials and what to consider during planning and design stages
• Assessing the benefits of decentralised vs traditional vs hybrid

• Challenges today: the track and trace landscape, site burden, and trends
• Deep dive into shipment and site storage tracking
• Data silos across the supply chain and how technology can be leveraged to a centralized model
• Use case: the drug journey taking into account regulation requirements
• Tips for implementation and key takeaways

• What are the benefits of remote monitoring patients in clinical trial design?
• What are the concerns about remote sampling in clinical trials?
• What can be reliably measured from dried blood microsamples and how does that effect clinical trial design and deployment
• Pharmaceutical approach to offering remote sampling in clinical trials

• Breaking down all that you need to know about CBP and other agency importation requirements to facilitate clinical supply shipments
• Receive detailed information on how to correctly declare biological products at the US border (Ports of Entry)
• Discover which biological products may have transportation restrictions that must be factored into your clinical supply chain strategy
• Covering the importance of permit requirements, including looking at whether a biological material may be hand-carried in the air environment, and what the proper labelling and packaging criteria are