Outsourcing in Clinical Trials West Coast 2021 - A Virtual Conference

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

• A word on Novotech
• Current trends for clinical R&D
• Ensuring Clinical Trial Continuity during COVID-19
• Leveraging regional advantages to accelerate development

• The importance of a governance committee and meeting schedule to address milestones and risk management
• Monitoring CRO engagement using high level metrics on start-up aspects to draw up timelines
• Focusing in on inspection readiness to ensure correct documentation on CRO oversight
• Navigating best practices to handle turnover by collaborating with your CRO and establishing key expectations

• Choosing the right vendors based on the population, indication, and country/site mix
• Establishing and nurturing relationships with patient advocacy groups, key opinion leaders, and registries
• Harnessing the power of social media and the rare disease space
• A look at the impact of COVID-19 on rare disease trial recruitment
• Utilizing patient services to support recruitment and retention including the use of translators/interpreters, travel concierges, home health, etc

• Developing a clinical trial model that can withstand global disruption
• Switching gears: Analysing which parts of our trial can go virtual
• Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic
• What contingency plan and tech can we use if patients can’t get to clinic- remote assessments?
• Future trials: What are the long-term effects of the pandemic on clinical trials?

With the need to further minimize use-related hazards and risks, how much information do we need for a comprehensive safety evaluation?

• Considering the pitfalls with formative human factors studies vs market research
• Fit for purpose: Assessing human factors studies including flexibility, cost efficiency and more carefully managed resources
• Establishing a human factors validation study that tests intended uses, under the projected use conditions
• Incorporating Agency feedback and impact to IFU revisions
• Strategic planning: Considerations for pediatric indications requiring human factors studies

• What’s the benefit of doing an RFI for a select few vendors prior to RFP?
• How can you be proactive when constructing RFI?
• Aspects to consider: what matters most; what attributes are you looking for; how to do your due diligence for an unknown vendor; how to clearly differentiate between vendors?
• Constructing an RFI/RFP with a niche vendor vs. large CRO
• Debating the optimal amount of protocol info to give vendors to ensure a full understanding

As early clinical studies have grown in complexity, the presenter will share insights on:

• Ensuring your strategies align with your desired endpoints
• Informing key decision points in early clinical trials
• Working with adaptive study designs or hybrid designs
• Planning ahead for unknown issues or changes
• Incorporating a risk management strategy

As a company transitions from a start-up to a larger business, what are the steps to manage this process?

• When is the best time to expand and what resources do you need to have for a smooth expansion?
• Does expanding your operations mean you need to outsource more?
• Examining how to make decisions on which operations to outsource at each stage of a company’s growth
• Identifying investment areas and how to go about acquiring the funding
• Why is it imperative to implement change management and process improvement during organizational growth?

• “Career limiting” Decision?
• So many choices/ So little time!
• CRO Location?
• Previous Experience with my company?
• Therapeutic Category experience?
• Size of the CRO vs My Needs?
• Costs?

This session will focus on the key drivers for consideration for planning a unified Clinical Technology environment, including  

• Using a requirements driven approach for Vendor & System Selection
• Assessing different platforms to enhance productivity, cost efficiency and expedite decision points
• Pros and Cons of using a Primary Vendor versus Best-of-Breed
• Cross System Integration and Efficiencies
• Change Management & Validation consideration

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. Attendees will learn to: 

• Establish a global DCT platform and library-focused approach
• Evaluate country-specific regulatory requirements and feature specific limitations
• Develop a unique, efficient approach to global device provisioning
• Assess DCT vendors for optimal capabilities related to integrations, technical helpdesk and multi-lingual support availability

With the industry forced into a remote setting, how can we be smarter about this

• Mitigating COVID-19 risks with virtualization methods
• Debating the idea of having a hybrid model by mixing traditional and remote methods
• Exploring how the rise in digital technology has enabled the move towards virtual trials: What tools are out there?
• Considerations in trial design to enable remote data capture

This session will share best practices learned during the COVID-19 pandemic to successfully scale decentralized across all trial sizes and therapeutic areas.

• Why decentralized and hybrid are an imperative for any size trial or therapeutic area
• Lessons in scaling decentralized and hybrid trials to meet the needs of any size study
• Utilizing AI-enabled technology to drive patient recruitment, site engagement, and risk-based monitoring

When do you need it? When to outsource? And what should be in an eTMF?

• Exploring the current trends in streamlining clinical trials with eTMF
• Identifying what internal resources you have to manage eTMF and what can be outsourced
• Allocating a team member with internal authority to be the TMF owner to ensure inspection readiness
• Identifying how eTMF can quicken study start-up to improve overall trial efficiency

The FDA LPAD pathway to approval can be helpful, if you work with a limited population with a life-threatening disease (Limited Population Pathway for Antibacterial and Antifungal Drugs)

• Outlining criteria for LPAD trials: working with small patient pool with a life-threatening disease and unmet needs?
• What drugs have been approved under the LPAD pathway?
• Pinpointing the challenges of these trials such as enrollment and understanding patient motivations
• Discussing the FDA guidance and parameters on LPAD approvals
• Real life case study examples

• Anticipating the realistic shift towards incorporating new technology, accelerating oncology drug development by investing in training and services
• Investigating methods to make cutting edge digital tools more financially accessible to allow for its wider use and benefit by smaller organizations
• Appreciating the incorporation of mobile technology in clinical trials which enables easy accessibility for patients
• Considering the risks regarding the reliability of data and technology
• Connecting with the right technology vendors in a growing and competitive industry to ensure that you receive the best quality service

• 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?

• Ensuring objectives are synchronised by sharing protocol insights with patients
• Identifying strategies for translating patient experience into protocol design to enhance engagement
• Collaborating with KOLs in patient populations for study development and setting up advisory boards

• Reducing patient (and caregiver) burden
• Building flexibility and patient choice into protocol design
• Future-proofing rare disease trials
• Case Study: Special considerations for rare pediatric populations

• Converting the emotional perspective to a data driven patient voice to all stakeholders in the trial
• Working with PAGs to develop the lay language for your trial ensuring patients clearly understand the study
• Discussing how to get patients involved in the trial design and to further promote the study
• Developing a strategy for social media and participation in online communities
• Putting patients at the steering wheel by inviting them to join advisory boards and examine recruitment strategies for a patient-focussed approach

• Exploring different approaches to finding niche CROs to ensure your partner can meet your specific needs
• Looking into unique ways niche vendors approach standard procedures such as enrollment and retention
• Identifying the issues that arise from high turnover rates in smaller CROs and putting a contingency plan in place to manage that risk
• Highlighting the advantages of niche CROs focussing on a specific indication and therefore having outreach in that patient community

• Building relationships between stakeholders to become the sponsor of choice for CROs/sites
• Determining your outsourcing needs by identifying in-house capabilities
• Exploring different types of collaboration between sponsors, CROs and niche providers: what outsourcing models work for you?
• Utilizing the procurement team for cost savings, improved budgeting, technology, and stronger partnerships
• Identifying pros and cons of using niche providers to meet your needs

• Advantages of remote vendor audits; can this be done for small/niche vendors?
• Importance of having preliminary conversations regarding logistics and how docs will be shared remotely
• Front-end planning: Working with your auditing team to scope out the most effective process for a remote vendor audit
• Exploring regulatory agencies view on remote audits and when going onsite is mission critical
• Will this continue post COVID as we see cost savings and better adaptation to technologies?

• Questions to ask your provider so that you can ensure they have understood your needs
• Identifying exactly what you need from a CRO and what aspects can be better managed in house
• How best to negotiate the best teams and what to look for when reviewing the CVs of potential project managers
• How do you know when you have hit on the right partner? Our panel share their thoughts on what makes them know they have found the right vendor

• 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

• Investigating what is needed to properly resource an early phase study to ensure you have set aside sufficient time and budget
• Assessing various study designs for early phase trials to decipher which is best for balancing patient safety with quick progression to Phase II

• 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

• How COVID-19 Trials have rebalanced speed vs. risk
• How the Pandemic accelerated the demand for advances in technology
• How the world has moved to rapidly adopt decentralized trials and DTP
• After the Pandemic, what will remain and what will fade away?

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

• Optimize buffer stock management and forecasting
• Automate IRT supply strategy updates to reduce cost, risk and effort
• Manage and oversee supply chain with flexible self-service tools and actionable insights
• Support traditional, decentralized or hybrid trials with flexible IRT strategies
• IRT design best practices for complex and evolving trial designs

• 80% of trials don’t hit enrolment timelines- Identifying how RWE can be used to locate specific patient populations
• Delving into electronic medical health records to identify patient numbers before setting out study parameters
• Navigating RWE to gain metrics on how many patients sites bring in to improve site selection
• Highlighting the benefits of utilizing RWE for protocol modelling and regulatory submission

• Strategies to alter sponsor processes ensuring more robust monitoring whilst keeping an open relationship with vendors
• Deciding on the level of governance depending on critical data and level of risk
• Utilising internal SOPs to guide you on vendor oversight specific to each individual provider
• Focussing in on inspection readiness to ensure correct documentation on CRO oversight and governance plans

• Evaluate how to meet changing pandemic-influenced patient and practitioner demands using innovative medical device designs
• Hear a case study on how needle-free, vascular access innovation aims to reduce patient pain, anxiety, and practitioner risk while improving quality outcomes, system efficiency, and serving as an asset for socially distanced healthcare
• Explore the innovation and technology needed for remote operations and staff training during the pandemic
• Consider how to do pilot testing, introduce new products, and support hospitals during the Covid-19 crisis, and how this will shape future business models

• Defining the terms and answering common regulatory questions
• Designing the Extractables Study; breaking down guidance documents and everything you need to know:
  • Time, Temperature, Solvents, Endpoints
  • Analytical Evaluation Threshold (AET)
  • Instrumental Analyses
  • Total Non-Volatile Residues
• Offering insight on how to using the Extractables Data to prepare for Leachables Study
• Designing the Leachables Study – is it possible?
  • Device Use, Combination Devices, Implantables
  • Compounds not yet Identified
  • Method Qualification

• An update on how US medical device industry is dealing with the transition to the European Medical Device Regulation
• Looking at the immediate and long-term implications on different medical device products and how the regulation affects global operations for trial sponsors
• After the application deadline was postponed from May 2020 until May 2021 due to the global pandemic, are medical device companies on track to meet their new requirements?
• Highlighting changes to the revised standards, such as ISO14155, the impact of changes, and the greater need for clinical data in general as a result of MDR

• Reviewing the FDA guidance for post-approval surveillance requirements for medical device trials
• Breaking down the guidelines on balancing pre-market and post-market data collection
• Discover the large variety of types of post-market studies that are acceptable to FDA
• Laying out the model for collaborating with the FDA to apply the guidance in a mutually beneficial way

• Diving into the latest technology trends for digitally streamlining medical device trials
• A hybrid area: exploring how digital health tools can power successful medical device trials and conversely the connected and wearable MedTech products offering solutions for pharmaceutical clinical trials
• Assessing the future of telehealth and telemedicine in shaping patient monitoring norms
• Hear updates on the regulatory environment for digital health and the FDA’s stance on this market

• Mapping out everything to consider when partnering with a service provider, such as a CROs’ regional expertise, monitoring capacity, site relations and network
• Looking at your company’s needs and finding a medical device partner who will be the perfect match for your trial
• Sharing experience on how to deal with your vendor going through a mergers and acquisition and smoothen the transition
• Hear advice on how to set up and retain an effective relationship from the beginning, with case study examples from device trials and lessons learned

In this keynote session our guests will introduce the topic with a 30min debate, which will be followed by an interactive panel discussion with both panellists and the audience

• Sharing first-hand experiences of coping with the impact of Covid-19 disruption on global clinical operations
• Exploring strategies for medical device companies to create self-sufficient local trial operations
• Debating which regions are best for US trial sponsors from a regulatory, financial, and operational point of view
• Looking at factors to consider such as patient populations and local expertise needed for your trial
• Hear lessons learned from working in US versus international sites and key tips for moving forward
• Offering different experiences of working in different regions and lessons learned

• Diving into the advancing space for medical device trial space for women’s health indications
• Discover the rise of FemTech and women’s health medical device innovation
• Highlighting key considerations for protocol development of trial design to ensure day-today operations meet patients’ needs
• Exploring how virtual and remote trial models can benefit women’s health trials, such as for gynaecological products and how Covid-19 has accelerated this shift

• Hear a case study of overcoming the clinical operations hurdles for a challenging women’s health study
• Providing key tips on how to establish relationship and trust with all stakeholders, from female patients to sites
• Sharing experience of partnering with and training large site teams and motivating sites to meet recruitment targets
• Discover strategies for successful patient recruitment amid the disruption of a global pandemic in an already complex trial environment

• Hear first-hand experience of running a virtual medical device company developing ophthalmic treatments
• Sharing experience dealing with the supplier delays during the Covid-19 and overcoming these issues
• Providing expert guidance on how to choose the right collaborator and create effective partnerships
• Thinking strategically about how to create sustainable growth from pre-commercial all the way to global commercial market access