Outsourcing in Clinical Trials Europe 2021- Virtual Conference

• Understanding your counterparts won’t necessarily have the clinical knowledge required to action next steps and identifying how ClinOps can help to explain in more depth
• Changing up the traditional processes by selecting a team member to be responsible for regular CRO communication to ensure all parties are on the same page
• Best practices for keeping CROs in the loop at each stage and drawing on their extensive experience to solve problems
• Appreciating the key to success is to improve personal relationships with your CRO to fully understand your team
• We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

• Accessing Australia’s ecosystem for early phase trials. A case study
• Accelerating patient recruitment in Asia for large complex trials
• The advantage of running global trials with regional CRO partners

• Building the company internal virtual trial eco-system is key to make virtual/decentralised trials happen
• “Perfect” is the worst enemy of “feasible” – hybrid models may be superior to 100% virtualized
• Some elements of virtual trial may need substantial and disproportional investments (e.g. digital biomarkers) for trial to be fully virtual
• Virtual trial also reaches beyond mere execution – with value to be obtained from design, planning and monitoring through digitalized business tools and processes

• Exploring technology used to support submissions
• Global recruitment of rare disease patients- discussing social media communities, websites and patient registries
• Decentralized Clinical Trials- assessing remote data collection and review
• Patient apps to coordinate travel, reimbursement, visit reminders
• Debating the uses and limitations of eCOA
• The importance of understanding the disease and patient community

• The importance of developing a global strategy for your biorepository and archiving needs
• Addressing the challenges you face
• Should you outsource your clinical research asset storage and management?
• Future considerations impacting your biorepository and archiving activities

• Influencing teams to engage early with patients, caregivers and patient advocacy (Alligator vs. Judge brain)
• There are many right ways to involve patients early and within your program
• Review a case study of examples and impact
• How working with patients and advocacy can reduce trial burden and boost patient enrollment
• Importance of Inclusive Research: how to increase under-represented patient populations into your trial

• Understand the potential concerns sites may have with remote visits
• Determine ways you can address these concerns
• Learn how to successfully role out remote visits to your sites

• In a post-COVID-19 landscape how can we create a more virtual patient recruitment process?
• Inclusion/Exclusion criteria- you’ve designed the perfect protocol, carefully thought out criteria but this perfect population doesn’t exist and your site can’t achieve it, what should you do?
• You have a clinical trial where the disease is not officially a rare condition but it is also not common, you still need to enroll a large volume of patients, what would be your strategy?
• How can you encourage patients to sign up to trials and come to the trial site/hospital when they are worried for their health?
• The Google Effect: with more patients/families using Google to learn about trials and the risks, how do you communicate to patients and their extended support group that they should join your study?

• Shifting from traditional research to artificial intelligence to redefine how pharma companies are research and developing new drugs
• Exploring the role of artificial intelligence in automation of business processes, gaining insight into data and making critical decisions
• Discuss who are the new stakeholders involved in this aspect of clinical trial research

• Defining countries in the CEE: Population, EU vs. Non- EU, health care structure, standard of care and similarities in the health care system
• Exploring the regulatory & therapeutic landscape
• Logistics: Looking at tasks and hurdles with import and distribution of study drugs
• Import licenses
• Examples of which countries need QP-release
• Exploring IT and privacy aspects including GDPR

Benefits of a centralised outsourcing process including more consistent pricing, time reduction for selection, outsourcing experts and maintenance of a global repository of vendors. The process for the identification and selection of Vendors includes:

• Establishment of Vendor requirements
• Identification of potential Vendors
• Evaluation of potential Vendors including risk assessment
• Selection of final Vendors
• Approval of the selected Vendor
• Contract with the selected Vendor

Outsourcing biometrics separately from clinical services brings increased data quality and access, and reduced costs. Implementing a data strategy and data standards maximises savings.

• Understand the risks of not having a data strategy and the benefits of having one
• Learn the best practices around data strategies and standards
• Identify the key steps in defining a data strategy and its use in standards development for CRFs and databases, data reporting and key biometrics documentation

With investors holding onto their money due to an uncertain environment, how has COVID forced people to find new ways of doing business?

• Contracting and budgeting during COVID-19 – lessons learns and best practices for crisis management
• Strategic approach: Exploring results from model testing in order to release more funds
• Debating when to look at alternative funding such as funding via a strategic partner: How to maintain a level of control over your trial
• Discussing options of offshoring your trial to reduce costs

This session will give you 5 key takeaways for how and why you should incorporate wearables into your study.

• Discussing what wearable technologies are available and accepted by regulatory authorities
• Exploring home monitoring technologies to collect patient data in a timelier manner
• Overcoming challenges when shifting to wearables whilst ensuring patient safety
• Considering the infrastructure required for wearables when running a large multi-region trial
• How are wearables being more widely used to help with reimbursement?

While wearable sensors and other connected health devices have been in the market for a number of years, pharma has been slow to adopt new technologies driven mainly by concerns over patient data security and privacy. As these issues are addressed, many sponsors and CRO’s are now faced with developing a sensor strategy in support of more flexible, patient-centric trials. Identifying the right sensors in support of hybrid or virtual trials is only the beginning. The ability to distill meaningful clinical insights from massive amounts of data requires a dynamic approach to data ingestion and analysis that will ultimately have the desired impact on the development of new digital endpoints.

• A risk management approach to data use
• How data can be used to best engage patients and sites
• Using PEPS (Patient Empowered, Privacy Secured) approach as an essential privacy component
• A look into the future: what could this be used for?

• Scientific, regulatory and operational considerations
• Is BYOD really cost effective?
• Current data on patient preference for BYOD versus a “provisioned” device
• How to keep your patients engaged and compliant in a BYOD study

• Why patients do or don’t participate in a clinical study?
• Is ageing significantly impacting clinical trials perception and digital technology acceptance?
• Are patients ready for decentralized trials?
• Results of a +1,000 patients study conducted in collaboration with patients associations across US and Europe

As the landscape for RWE and AI continues to evolve, this session will look at the implications for current infrastructure, governance, operating models, people and processes of pharma companies.

• A case study look at the insights of market leaders who have developed end-to-end RWE programs
• A delve into the future: How is the data landscape evolving and how will this impact on AI and RWE?

• Understanding how COVID restrictions are impacting today’s trials
• How the right IRT can ensure an accelerated start with hybrid trials
• Applying the right expertise, how to safeguard your trial when the unexpected happens

• Understand how public health challenges like the COVID-19 pandemic require a combination of therapeutic solutions which align to the pathophysiology of the disease
• Learn from industry’s experience on clinical development in COVID-19 for previously approved products, and the development journey towards approval and patient use for COVID-19
• Appreciate the contribution of different evidence sources contribution, from early access programs to previously generated data in other indications, for development success
• How agencies have shown flexibility and leveraging it for future indications

Harnessing technology will help your transition from traditional trials to hybrid and decentralized trials. This presentation will share insights on:

• How technology can assist you with country and site selection, and investigator strategy
• How to gain a complete view of your trials from multiple data sources
• How to design a hybrid monitoring strategy
• How technology can reduce study set-up time
• How to minimize cost and disruption during mid-study protocol amendments
• How to automate generation of SDTM data

• The Truth of Clinical Trials in Japan
• Strategic Positioning of Japanese Studies in the Global Drug Development Context
• Best Practices to Outsource your Clinical Trials in Japan – Our Solutions, Your Success

This talk provides you a comprehensive overview of the rapidly developing landscape in Patient-Centered Clinical Research. 

• Defining what we mean when use the terms: Patient Centered Research, Patient Engagement and Patients as Partners
• Reviewing the major regulatory developments in support of Patient Centered Research
• Gain insights from the largest bi-annual global survey on patient and public perspectives of clinical research
• Explore the work being done to measure and evaluate the value proposition of Patient Centered Research activities
• Examples of Patient Centered Research programs, including sharing research results and acting-on the patient community’s input, and developing user-friendly websites

• Factors to consider in forecasting and optimization
• Best approaches to IRT to optimize clinical supply
• More dynamic ways to address predictive resupply

How can we change this from a ‘us and them’ situation, to a successful working relationship?

• Identifying a proactive CRO who can be your eyes and ears- Do they have regulatory and clinical knowledge in the regions you lack?
• Methods to encourage your CRO and project manager to drive the study forwards and buy into your vision
• Challenging your CRO selection process to include more in-depth questions to ensure you make the right choice
• Evaluating performance: Don’t be hesitant in changing project managers if you feel you aren’t being taken care of

The discussion will explore how having a good medical writer involved in writing protocols brings value in many dimensions, including:

• Efficiencies during protocol development by keeping authors focused on content and key objectives relative to registration goals
• Improved data quality and study efficiency through consistency and clear messaging to study teams
• Streamlining downstream documents (CSR, CTD summaries) by ensuring the protocol provides the right information for ease of reuse

• Understanding how COVID-19 affected clinical trials and most impacted therapy areas
• Clinical trial disruption in countries most affected with COVID-19
• Disruption of pivotal trials and potential impact regulatory approval of drugs
• Learning from disruption and future path for clinical trials outsourcing

Revati Tatake or Bonnie Bain

• Why digitalization requires a holistic approach
• How data review (DM, Medical), programming, analyses, clinical operations and CTM experiences need to change
• What new technologies and platforms work best to accelerate digital transformation
• How mid-market companies are implementing a centralized clinical data platform for greater oversight and data control

• Exploring how the rise in digital technology has enabled the move towards remote assistance and telemedicine: What tools are out there?
• Innovative methods and technologies to improve chronic disease trial design with the patient voice at the centre
• Examining how COVID has changed the landscape and discussing how our response must also change

• What do patients want?  The value of patient insights
• Does site burden = patient burden? (or vice versa)
• Building an ecosystem focused on the patient for better outcomes

• Exploring how the rise in digital technology has enabled the move towards remote assistance and telemedicine: What tools are out there?
• Innovative methods and technologies to improve chronic disease trial design with the patient voice at the centre
• Examining how COVID has changed the landscape and discussing how our response must also change

• Thinking ahead: Evaluating at which point in the trial process CROs should be involved to have the maximum impact
• Considering your CROs wealth of experience and treating them as an equal partner rather than transactional
• Identifying aspects of protocol development your CRO can advise on, such as which countries to approach first
• Risk sharing: Utilizing CROs who have skin in the game to help set up contracts

• Getting the best from the partnership approach: why trust and flexibility matter
• 3 main steps to building trust: relationship, quality and compliance
• Understanding the benefits of process transparency
• Case Studies: Direct-to-Patient and Cell and Gene Therapy Logistics Platforms

• Navigating the complexity of country-specific regulations and which EU countries to consider for remote and virtual trials
• Debating the idea of having a hybrid model by mixing traditional and remote methods
• Exploring how the rise in digital technology has inevitably lead to virtual trials
• Considering the challenges with retaining patients and investigators in these new trial designs

• Understanding the data flow requirements of long term development pipelines, real time data benefits and overall virtual trial management
• Technology and tools interacting with Patients which collects relevant clinical data
• Identifying the right technology for right data to be collected, planning integration & mapping with clinical DB/EDC

Historically, clinical trials have only been prominent within the healthcare industry. Now, COVID-19 has brought the speed and performance of trials into the glaring spotlight of public interest.

At this time of turmoil, digitization, decentralization, and sustainability are impacting traditional clinical trials. Join me to discover how logistics is adapting and responding to these trends that are here to stay:

• The role of a logistics provider in delivering patient-centric solutions
• Strategies for leveraging an integrated global network
• Deep-dive case studies on Direct-to-patient, Visibility & Sustainability

Inspection readiness and execution, the best teambuilding exercise ever

• Be prepared, not afraid
• Is a Mock inspection useful?
• Roles and logistics definitions are key to the success
• The agenda comes from the inspectors but you can still be in charge

As the industry continues to shift to decentralized clinical trial (DCT) approaches, sponsors and CROs must now focus on how to make this change globally.

• Understanding how to evaluate country-specific regulatory requirements and feature specific limitations
• Assessing DCT providers for optimal capabilities related to integrations, technical helpdesk, device provisioning and multi-lingual support availability

• Exploring the advantages and disadvantages of having study coordinators and CROs heavily involved in your trial
• Identifying potential challenges with study management and how to predict and overcome them
• Audience vote: Do you agree or disagree with the title?
• Final conclusion and takeaway discussion points

With the potential exceeding any other to revolutionize the healthcare industry, it is crucial to first understand the nature of blockchain technology, to distinguish the hype from the reality and then to see real-world case studies of how blockchain, combined with other technology such as AI, will be applied to healthcare systems.

• Exploring regulatory requirements and compliance considerations
• Delving into key data challenges and technology solutions
• Pinpointing the benefits of a unified platform

• Recognising the ability of AI to keep track of the data we don’t collect
• Harnessing the power of AI to identify the most suitable sites using electronic health records
• Smart Analytics- utilizing databases to identifying which sites are enrolling the most suitable patients for your study
• Considering what processes can be automated through technology and AI to minimize human error

This session is part of the S-Clinica Insights series, where we shine a light across the entire clinical trial ecosystem, focusing on various aspects of clinical supply forecasting, budgeting and management. Ryoma (Ray) Collia will be speaking with Dr Vivienne van de Walle who brings a deeper insight and awareness of the challenges that clinical sites face due to pandemic related changes, the elements of risk that Sponsors need to be aware of when planning their studies.

• Redundant data collection in study design
• Number of data collection instruments in clinical trials
• Impact of data collection on the patients

• Why, and how, pragmatic clinical trials are taking off in Europe – could the pragmatic trial replace randomised clinical trials?
• Exploring how the rise in digital and data technology has enabled the move towards pragmatic trials and RWE: What tools are out there?
• Considerations in trial design to enable a successful study

• Experienced leader of scientific operations for drug discovery in both the pharmaceutical and CRO industries.
• Driven to provide actionable data enabling biopharmaceutical research and development
• Collaborative partner ensuring licensing and scientific support for corporate development initiatives

• Innovative ways to inspection readiness in sponsor oversight
• Integrate all stakeholders (Trial Management, Data Management and Statistics, and PV) into the oversight process
• Integrating oversight process and business intelligence on trial data