Outsourcing in Clinical Trials Europe 2022

Driving the adoption of decentralized trials in Europe; where are we at and what can we learn from the US?

• Identifying the pain points with implementing a decentralized trial in Europe
• Educating patients with active learning – improving the informed consent process
• Addressing readiness among sponsors and healthcare professionals to adopt a decentralized trial
• Advice to trial sponsors to make it happen – having a digital mindset
• Key drivers for ethics committee acceptance and which European countries to focus on
• The budget conundrum – how can your decentralized trial be less costly?
• Practical takeaways from a case study and how US decentralization can translate to Europe

• Benefits to uniting continuous, objective technology-acquired data with subjective clinical outcomes data
• Keys to creating a sustainable approach to decentralized trials that leads to greater flexibility and better clinical insights
• Enhancing value demonstration through real-world effectiveness
• Use cases examples across select therapeutic areas including oncology, Parkinson’s disease, and cardiology
• How to get started – benefits of a pilot study

This session will delve into Janssen’s strategic site engagement piece, focussing how Janssen wants to shape and intensify its relationships with sites.

• Highlighting what Janssen wants to do to drive and advance existing relationships with sites
• Thought-sharing how Janssen might need to change its site selection process
• Potential benefits for sites and overall trial performance
• Outlining how this might affect innovation like DCTs

This interactive session will cover diversity and race inequalities in clinical trials; why we have underrepresentation and why it’s vital we improve this now. Robert will give a 15min overview on the challenges and will then open up the discussion to the panel and audience. (Audience are encouraged to ask Qs throughout on Slido)

• How can we improve engagement by paying more of a focus on race and socioeconomic disparities?
• Exploring the role of patient organisations/ advocacy groups in tackling underrepresentation
• Highlighting the impact on your trial if all groups aren’t adequately represented – ask ourselves why not
• Brainstorming solutions: What actions can we take now to get groups interested in participating in trials? Speak to them!
• Advice on how best to reach out to patients to understand their needs
• Informing patients efficiently and translating the trial into a language they understand

This presentation will discuss the evolutions of CRO-Biotech integration and partnership models and best practices for success. 

• Spectrum of Biotech/CRO models
• Pros and Cons of each
• More detailed description of newer and more integrated models
• Discussion of some of the newer and pioneering approaches
• Preservation of Biotech ownership of assets in all models

Our expert panel give their thoughts on continuing a clinical trial through the pandemic, using concrete examples to deliver key takeaways to the audience. 

• Do you continue or pause? Making the decision regarding trial conduct in the pandemic situation
• Operational challenges as the inspiration for the innovative or…. not innovative solutions
• Exploring the regulatory approval/GCP approval aspects
• Advanced risk management for the greater good

• 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

This session will be a quick fire 15mins presentation followed by 10mins audience Q&A

• Working with patient advocacy groups from pre-study start-up to facilitate engagement
• Overcoming the barriers and challenges in patient engagement
• Understanding where patient engagement gives you an edge over your competitors
• Getting patient more involved in the trial design decision-making process
• Seeing patients as passionate advocates for your trial utilizing their voice to engage others

• Precision For Medicine (PFM) in the Clinical Research Arena: What We Know, Where We Are, and Where We Want To Be
• PFM After the COVID-19 Pandemic: Partnership Model To Create an Innovative Environment in Clinical Research
• Anticipating the Future: PFM Integrative Approach To Support Biomarker-Driven Patient Enrollment in Clinical Research

• Transitioning into a clinical company – FIH FIMEA authorisation 2018
• Pre-pandemic first in human trial – SAD 2019
• Second trial in the mist of the initial stages of the pandemic – MAD 2020
• Third clinical trial two years into the pandemic – EEG/fMRI 2022

Clinical trial regulations make sponsors responsible for the conduct of decentralized clinical trials (DCT) in accordance with GCP, as well as other laws and regulations. This responsibility extends to technology deployed in the conduct of DCT. In this session, trial sponsors will learn about:

• GCP, privacy and clinical trial requirements to consider when selecting and configuring technology products
• Common challenges in conducting due diligence in DCT technologies
• Suggested approaches for evaluating DCT technologies

With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. How do we move forward from here?

• Rethinking your site management strategy to minimize overburdening sites
• Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind
• Advice for the ClinOps team on working closely with the CRO to avoid unnecessary screening/visits
• Give your site the freedom to breathe! Have a virtual meeting/call
• Communication is key- how can the sponsor/CRO help and support as a partner
• No one size fits all with oversight, be clever with strategies to ensure GCP and patient safety without overburdening the site

Exploring the strategies and partnerships that contributed to the success of the study

• How CRO and Sponsor drive innovation and embrace digitalization
• How to increase patient engagement and retention
• How to improve data collection and protocol adherence
• How to build a solid platform to have all patients data in

• What is special about a dialysis population
• Individual units vs. larger dialysis organizations
• What about a different approach to feasibility, screening, recruitment, and retention?
• The role of (big) data
• Has the future already started – Artificial Intelligence and other newfangled stuff

Sponsored by eClinical Solutions

Uncovering the key pain points with recruitment and how social media can help plug the gap

• Presenting three type cases and strategy of using RWD and social media for support recruitment
• How to combine the use of EHRs and social media/health data to locate your patient pool
• Social media increase during the pandemic; how to use this to your advantage?
• Best practices for Facebook adverts to funnel eligible patients into your trial– get patients reaching out to you
• Validating patients efficiently to ensure highest conversion rate possible
• Advice on creating your first social media campaign and outlining the barriers

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate® Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. 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

Creating a clinical trial landscape where small companies have better access to tech and innovation 

• With biotech companies increasing in numbers and influence on the market, what tech is available for them?
• Overcoming the barrier of cost as well as acceptance and adoption of new technologies- Can we convince small biotechs to change the way they work?
• Discussing the possibility of vendors having a subset of tools that are affordable and can be easily adopted by smaller companies
• Does technology deliver according to its promise?

• Impact of COVID on Clinical Trials from March 2020
• Using census data as a means of refining investigator selection based on availability of diverse populations
• Optimizing clinical trial design through dynamic simulation tools

(15min tech spotlight)

This session will consist of a practical technology demonstration of the topic and interactive Q&A with the audience

• The utility of digital measurement standards
• Look under the hood: defining measures and modality standards
• How can we collaborate to create standards, how can they be published
• WIIFM: tech companies, sponsor view, regulatory

• Key learnings from running DCT/hybrid trials so far
• Points to consider designing your coming clinical trials using DCT processes and technologies
• The building blocks in your DCT/Hybrid trials

• Presentation of the draft guidance
• Analyse and comments on the guidance, what is missing and could be changed at a later stage
• Personal reflection on the elements which might be more difficult to implement for the industry than others

• Data protection compliance and business risks
• Privacy by design: beyond the sexy terms
• Total outsourcing and compliance needs
• Coping with exponential growth of data protection laws
• How smart implementation can help you achieving your goals
• What MDT can do for you

• Sharing Sanofi’s experience with using RWE for clinical development
• Better definition of patient populations and drug combinations
• Higher evidence of external validity providing confidence in trial results
• Leveraging secondary use of data to gain efficiency and reduce costs
• Assessing efficacy of treatments in early phase trials to inform development strategy

Floris Morang will address challenges and opportunities that will help organizations select and deploy the right eClinical ecosystem and drive optimal study outcomes.  From remote patient recruitment and enrollment to integrated data capture including EHR, ePRO/eCOA, device, and sensors, we’ll discuss how to adapt and scale according to clinical trial protocol and needs.

• There are a broad range of eClinical tools available that can improve the quality and speed of your clinical studies.
• It is important to understand how to best apply them according to study design and clinical trial needs.
• CROs and eClinical vendors can be included in the early design stage of your studies to ensure the best possible configuration.

Conduct of clinical trials are increasingly becoming expensive. Significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible.

In this talk, we will provide an overview of the application of Artificial Intelligence methods in clinical operations including evolution from a descriptive statistic and visualizations to traditional machine learning methods to now deep learning AI methods. We will delve into details on the application of machine learning methodologies, specifically deep learning sequential methods to optimize clinical site monitoring for site facing personnel.

• Oversight with less presence– designing an oversight plan based on KPIs, fewer monitoring visits and more virtual meetings, how to make this work
• Lessons learned on how to effectively build working relationships remotely
• Strategies to deliver training and upskill your clinical trial team
• Handling hard discussions with the site remotely if can’t get there in person
• Guidance on improving CRO communication channels– how to keep CROs in the loop and draw on their extensive experience
• We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

• What is Adaptive Design?
• Advantages of utilizing an adaptive design in Oncology trials.
• How does this Adaptive Design differ from the traditional approach?
• What to expect, from a CRO and Sponsor perspective, with an Adaptive Design approach to clinical trials?

• Impact of increasing complexity of clinical trails’ design on study cycle times
• Why Operations deserve a seat at the “study design table”
• How to assess complexity of clinical study protocol
• Driving cultural change and challenging the status quo during protocol design phase
• Does operational complexity increase patient burden?

This presentation will examine the impact of the CTR on site contract timelines and start-up during the three-year transition period. Trial sponsors have through January 2023 to move their trials under the new regulation, and until then may elect to continue working under the legacy rules. As site contracts must be in place before site initiation visits can occur, contracts could emerge as the most prominent roadblock in the initiation of future trials. What impact will the CTR have on site contracts, and what risks and opportunities will result from the new rules?

• The ability to submit one online application for approval to run a clinical trial in multiple European countries, instead of separate applications in each country
• Tools that allow national regulators to process trial applications across borders collaboratively, request further information, authorize or refuse trials, and oversee trials
• Easier expansion of trials to additional European countries
• Availability of information to any interested party through a public website

• General update about healthcare access for Ukrainians in Poland
• Participation of patients from Ukraine in the clinical trials conducted in Poland – Good practice of the clinical trials industry in Poland
• Notes from personal experience

• Within the SGS Clinical Operations department, we apply integrity on a continuous basis towards our sponsors too
• This doesn’t only mean advising a sponsor on what they can do, but also what they cannot do
• Come and join our session to hear all about on how this difficult message can be conveyed with ease to your clients as well

• Current guidelines published by journals in medicine and especially oncology, where you have to comment on how you have managed the diversity and inclusion in your clinical trial is necessary to publish it
• Why it’s still a challenge for Big Pharma?
• Why are some populations still underrepresented in a clinical trial and the scientific societies and the Governments are trying the pharma companies take into consideration this approach, to include the minorities in clinical trials?

• 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?

• Through a pioneering taxonomic lens powered by GlobalData, the goal of this session is to:
• Characterize the multiple facets of decentralized, remote and hybrid trials
• Analyse the adoption trends and forecast of specific decentralization approaches and components
• Understand the decentralized trial landscape by therapeutic area, sponsor, etc.

• Establishing an architecture that imbeds the right business logic into your API’s and reporting strategies through sponsor/vendor collaboration
• Ensuring data quality and availability through the timely exchange of the right data, and building reports that matter
• Looking beyond data exchange to opportunities to automate workflows, eliminate redundant tasks and improve oversight
• Enabling faster decision making which improves data accuracy and patient compliance by simplifying the site experience

Cross-disciplinary appeal for less bureaucracy, improved patient safety and better trials

• Addressing the need to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper
• Working with regulators, policymakers, sponsors and ethics committees to discuss changes to regulatory guidelines, safety reporting and informed consent
• Ensuring these actions do not harm what they are meant to protect: quality and patient safety
• Reducing administrative burdens in safety reporting, informed consent, regulatory guidelines, and harmonization of requirements across the EU

The chair will give a summary of the past two days, the key takeaways and best practices moving forward. Audience views and comments welcome for the final discussion.

biotx.ai’s COVID-19 strategy is to find patterns linked to the disease in patients’ genomes as well as in the DNA of the virus. Marco will discuss this clinical trial testing process, why it’s a priority and what data is available.

•  Discussing best practices for finding and testing drug target candidates for drug repurposing
• Using UK Biobank data to match critically ill COVID-19 cases with healthy controls
• Exploring promising drug targets for the selective treatment of critical COVID-19 patients

• Stakeholder-centricity by design
• Case Study: Clinical investigator meeting during a Global Pandemic
• Case Study: Rapid protocol review

• Discussing how the Covid pandemic has accelerated e-Health & technologies
• Telemedicine, Teleconsulting & Teleremote: Is this the best way of patient management?
• Digital pharma solutions; the cardiotech accelerator experience

• Challenges today – Track & Trace Landscape, site burden and trends
• Deep dive – shipment and site storage tracking
• Data silos across the supply chain and how technology can be leveraged to a centralized model
• Use case review – the drug journey taking into account regulation requirements
• Tips for implementation and takeaways

• Case study of sponsor oversight system – May 2022 update & lessons learned
• What should you be doing now for data & inspection readiness
• CRO aspect: how can we ensure CROs deliver on what they offer?
• Proper documentation of oversight, how does it help in audits and inspections?

With only 5-10% of clinical trials expected to be fully de-centralized and 70-80% expected to be hybrid, sponsors, sites and CROs need to continue to solve the challenges of generating rich evidence in this Trial Anywhere reality. During this session, speakers will discuss:

• Capturing high-quality data that meets regulatory standards and using rich evidence to determine the safety and efficacy of a medicine, medical device, or therapy.
• Fusion of scientific and technological excellence to generate rich, gold-standard evidence.
• How therapeutic area and domain expertise augments evidence-generating technologies and methodologies.
• The impacts of decentralized and hybrid trials on clinical evidence generation including: the influences of patient accountability, how science drives rich evidence, and the impact of rich evidence on studies

• Introduction to Nestle Research & Clinical Research Unit (CRU)
• Key differences between Pharma and Nutraceutical Trials
• Challenges unique to Nutraceutical Trials
• Outsourcing needs and strategies
• Key takeaways followed by audience Q&A

In this session, Sinéad Callinan, Executive Director, Head of Delivery EMEA at THREAD will share her perspectives and best practices focused on scaled adoption of decentralized clinical trial approaches. Topics include:

• Global Implementation
• How to move beyond pilots
• The convergence of DCT technology and real-world data
• The use of analytics to prove out the value proposition of DCT
• The importance of working closely with research ambassador teams, participants & sites to enable change management

Is it worth tweaking the relationship? How do you know when/how to severe ties?

• Utilizing milestone data to identify if the CRO-sponsor partnership is efficient and successful
• Renegotiate – pros and cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
• Don’t burn bridges – identifying when to bail and how to go about it with grace
• Exploring exactly why the CRO isn’t hitting those milestones and what can be changed
• Practical solutions and case study to conclude