Outsourcing in Clinical Trials East Coast 2021

Juggling the needs of a shifting portfolio can be challenging – different portfolios we work on, especially those in different therapeutic areas, will have different requirements. In this session we will look at identifying which studies suit internal trials and which it would be most cost and time effective to outsource.

• Debating and identifying which studies suit internal delivery and which should be outsourced using realistic parameters
• Improving on field solidarity – ensuring both internal CRAs and CRO partners are working efficiently together towards the same goals
• How effective use of site managers can help studies to remain within time and budget

• A word on Novotech
• Leveraging APAC regional advantages to accelerate development
• Understanding the benefits of running clinical trials in China

At the OCT East Coast Conference we present the latest technology, CRO and patient recruitment etc companies and start-ups to showcase the solutions they can offer to a range of pharmaceutical companies. Now it’s time to reverse the conversation!

Hear from our panel as they debate what they are actually in need of – the business challenges and opportunities they would like to solve together with vendor companies and starts ups. Including:

• The issues they want their partners to help fix
• What are they looking to invest in?
• How can they differentiate between different vendors? And how do we know when we have hit on the right vendor?
• Do we even need to work with a vendor partner and what challenges can be best solved in-house?

Intro: The pandemic has accelerated the move to decentralized trials, and industry is moving this way:

• Regulatory support has been there for some time now (e.g. FDA and EMA guidance around decentralized trials, QbD, and related risk-based approaches e.g. RBM)
• Benefits for sponsors: time and cost savings through greater operational efficiencies e.g. centralized / remote monitoring; easier patient recruitment and retention; better medication adherence
• Benefits for patients: Easier and less burdensome to participate in clinical trials

However: With these benefits come critical operational challenges for trial sponsors, including:

• More “edge” devices (closest to patient) e.g. wearables create higher volume / velocity / variety of data (aka “big data”), making it hard for already overburdened clin ops and DMs
• New data sources and streams are creating a hard-to-manage mix of non-integrated point solutions
• Virtually all existing clinical technologies (EDC, RTSM, safety, etc.) were not designed for this new world and struggle to support it effectively

Prevail is helping leading trial sponsors successfully overcome key operational challenges of decentralized trials experience by applying innovative clinical technologies, domain expertise, and global support.

Selected case studies:

• Bringing together unified clinical and operational data from every trial system and data source into a single source of the truth
• Ability to effectively manage this data with real-time, holistic views and detailed drill-down reporting, with powerful analytics to help sponsors and sites manage more complexity and identify problem areas sooner
• Advanced clinical systems that allow companies to break free from established processes without adding risk, e.g. predictive, adaptive direct-to-patient drug supply
• Proven expert trial services to help design and implement decentralized or hybrid trials to optimize outcomes
• Ability to set up clinical systems quickly and adapt rapidly and effectively to mid-study changes
• Centralized risk management / remote monitoring capabilities
• Home assessments

• Sponsor Proactivity: What we can do better for the CRO before the start actually starts.
• Exploring the granular details that should appear in your RFP to find the right CRO (but often doesn’t).
• Tactics for Designing Feasibility Questionnaires: How to get faster responses without sacrificing valuable content.

When working on a study withSusan Lubin tight deadlines, is the full service or FSP model the best way forward?

• Comparing the FSP with full service approach – what are the positives and negatives to both so that you can make the best decision for your trial
• Can working with a preferred partner really save you money and time due to their ability to meet all your needs in house?
• Setting up governance and quality control meetings to ensure you remain in control of all aspects of your trial

A comprehensive sensor strategy goes way beyond sensor selection and data collection. Join Medidata’s Mark Matson as he breaks down critical outsourcing considerations including protocol integration, device acquisition and setup, global logistics support, site / patient training, and data management. Key takeaways for this session will include:

• Successful device selection and integration
• Effective device deployment and support
• Best practices for data capture and transfer

With an ever-more competitive market, how do we ensure the best teams?

• Exploring the strategies we can employ to ensure that we receive the best possible proposal from our preferred vendor even when having a smaller portfolio means that we don’t have the most leverage
• “Sharpen your pencil” – Exploring negotiation techniques so that we can ensure the best possible team and get the attention of our preferred vendor in a crowded marketplace
• Retention of your project manager and your team – are there strategies we can employ to ensure our ideal team isn’t pulled off our project?

• How to manage a direct to patient trial using effective eclinical Solutions
• Key technologies to directly manage direct to patient drug shipments
• Managing the overall information flow for all key stakeholders in DTP trials

Reserved for Axiom Real-Time Metrics

This session will take a deep dive into maximizing the value of device data.  Focusing on using the devices to  generate digital endpoints,  the potential to democratize clinical trials,  create robust data for payers and support labelling claims.

Time for some group problem solving! Delegates will be split into small groups and we will give you a nightmare scenario. Working together with your teammates, brainstorm ideas that can help you successfully overcome this stumbling block and ensure that the issue has the smallest possible impact on your resources and budget.

10 minutes will be given for each scenario, after which a spokesperson from each team will share your best ideas with the room before we move on to the next scenario.

‘Scenarios’ the groups will have to overcome include:

• Your CRO project manager has decided they want to take early retirement and move to Florida. What strategies do you need to put in place to ensure a seamless transition for your new PM? How would you go about finding the next perfect PM?
• Patients just aren’t interested in your study – recruitment is proving a struggle. How could you innovate your protocol and mix up your strategy to entice patients onto your study?
• Your competitor is launching a similar study to you. What should you do when negotiating with your preferred vendors and sites to ensure that your study is the one that is given their preference and their A-team?

This is a good opportunity for delegates to share their own experiences in problem solving and learn from each other’s ideas.

In this session Frank Leu, CEO at Novapeutics explores where he sees Blockchain going in the future, its implications and whether we should all be investing in it. Our expert will be answering such questions as:

• How can it be best adapted into a clinical trial?
• Which system should you use? It seems every vendor has the own system but how are we supposed to know which is the best?
• Is the FDA likely to pick it up?
• Will it actually save us money and time in the long run? Exploring examples of when Blockchain has been effectively implemented and the benefits it has had
• How do I persuade my boss that Blockchain is important?

In this session we will investigate how to avoid your TMF being the weak point in your trial and how digitalisation of your records results in a stronger study.

• Moving to an electronic TMF – what you need to know and the benefits it can have in streamlining the organisation and accessibility of your trial records
• The drawbacks to a paper TMF and the implications on your study if the records are not correctly kept
• The different systems vendors are offering and clarifying the main components your eTMF needs to have – from customisable user roles to automatic backup systems and the ability to easily search for the information you need
• Auditing – how a more reliable digital TMF can be more likely to pass the auditing process

Considering the complexity of today’s clinical trials, research staff need a direct line to study experts for real-time guidance or clarification of protocol instruction. Yet, traditional approaches to managing clinical trials separate those conducting research and those with study expertise.

It’s time to put clinical trial communication in the hands of research staff. In this session, we will look at a new approach for investigators and site staff to connect with both study content and experts so they can get the guidance they need, when and where they need it.

• How new technologies can be employed to make decentralized trials possible and discussing what tools need to be in place before you launch a decentralized trial
• Managing the admin responsibilities that conducting trials off-site can involve – getting it right so that the trial is run efficiently and saves your staff time
• The different models that can be utilized – from a completely virtual trial to a hybrid approach – ensuring that you pick the right model for your study in order to effectively streamline your processes

A discussion of the many different competing priorities that Biotech companies face in drug development and how the PRA team can lend support.

In this session, we welcome Brandon Maggio to discuss telemedicine and its implications for the future of patient centricity.

• How telemedicine and decentralized trials can be put at the forefront of patient engagement, breaking down the barriers to recruitment and giving us a better perspective on how your product will act within a particular population
• Exploring the overall perspective on why telemedicine can improve patient centricity and exploring if this method can reduce dropouts
• Examining the future of telemedicine and the uses it can have in improving study processes today

Leveraging predictive dosing with AI-enabled technology can be applied to analyze participant data and develop accurate predictive trends. When applied to dosing behavior, this information reveals which patients are most likely to maintain a high rate of medication adherence over the course of a study. Optimizing your patient pool for maximum medication adherence can have a significant impact on your clinical study.

• Higher performing sites: Predictive dosing enables sites to provide the right level of outreach to patients based on their anticipated behavior. This enables sites to be more efficient with resource management.
• Smaller patient pools: Using predictive dosing, you can avoid enrolling non-adherent patients who are more likely to drop out of a trial, reducing the need to “over-enroll” as a contingency for dropouts.
• Holistic data Predictive dosing enables a complete and more accurate picture of patient behavior and symptoms.

Time for some group problem solving! Delegates will be split into small groups and we will give you a nightmare scenario. Working together with your teammates, brainstorm ideas that can help you successfully overcome this stumbling block and ensure that the issue has the smallest possible impact on your resources and budget.

10 minutes will be given for each scenario, after which a spokesperson from each team will share your best ideas with the room before we move on to the next scenario.

‘Scenarios’ the groups will have to overcome include:

• Your CRO project manager has decided they want to take early retirement and move to Florida. What strategies do you need to put in place to ensure a seamless transition for your new PM? How would you go about finding the next perfect PM?
• Patients just aren’t interested in your study – recruitment is proving a struggle. How could you innovate your protocol and mix up your strategy to entice patients onto your study?
• Your competitor is launching a similar study to you. What should you do when negotiating with your preferred vendors and sites to ensure that your study is the one that is given their preference and their A-team?

This is a good opportunity for delegates to share their own experiences in problem solving and learn from each other’s ideas.

In this session Cathleen Platt, Head of Clinical Operations at Click Therapeutics, will discuss how she is working to make their trials more patient-focused and the technologies that can be utilised to achieve this goal, including:

• Ways to keep in touch with your patients (specifically newsletters) and how this has impacted engagement and retention rates
• Creating a patient-focused website to give reliable and interesting information on your trial and products and the benefits this has had on ease of patient recruitment
• To what extent does using even the most basic technologies make you look more modern and approachable in the eyes of your patients and how effectively does an innovative approach boost your profile above that of competing trials?

Further details to follow…

Getting a varied patient group is getting more and more attention in recent years but can it really help us achieve better results? In this session our panel will discuss:

• Exploring why, when the USA has one of the most diverse populations worldwide many of us struggle to recruit a varied patient population and whether improving our recruitment can improve our study results
• How Social Determinants of Health could be impacting our trials – will taking these into account improve the data we get from our trials?
• How should we be integrating SDoH’s into our study design to get the most reliable results
• The implications of not getting a diverse patient group – could this affect the safety of your product?

Considering the complexity of today’s clinical trials, research staff need a direct line to study experts for real-time guidance or clarification of protocol instruction. Yet, traditional approaches to managing clinical trials separate those conducting research and those with study expertise.

It’s time to put clinical trial communication in the hands of research staff. In this session, we will look at a new approach for investigators and site staff to connect with both study content and experts so they can get the guidance they need, when and where they need it.

By Teckro

Patient Centricity, Patient Engagement, Patients as Partners – these are not just “buzz words”. This talk provides you a comprehensive overview of the rapidly developing landscape in Patient-Centered Clinical Research. You will learn about a myriad of initiatives from regulators, industry, and advocacy groups aimed at improving and accelerating clinical research through collaboration with patients, their communities, and other key stakeholders.

• Defining and clarifying 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, including insights on participant experiences.
• Explore the critically important work being done to measure and evaluate the value proposition of Patient Centered Research activities, sometimes referred to as “Return on Engagement” or “ROE”.
• Analyze concrete examples of Patient Centered Research programs and projects, including sharing research results, collecting and acting-on the patient community’s input and feedback, and developing user-friendly registry websites that educate and empower patients and the public.

A discussion of the many different competing priorities that Biotech companies face in drug development and how the PRA team can lend support.

Leveraging predictive dosing with AI-enabled technology can be applied to analyze participant data and develop accurate predictive trends. When applied to dosing behavior, this information reveals which patients are most likely to maintain a high rate of medication adherence over the course of a study. Optimizing your patient pool for maximum medication adherence can have a significant impact on your clinical study.

• Higher performing sites: Predictive dosing enables sites to provide the right level of outreach to patients based on their anticipated behavior. This enables sites to be more efficient with resource management.
• Smaller patient pools: Using predictive dosing, you can avoid enrolling non-adherent patients who are more likely to drop out of a trial, reducing the need to “over-enroll” as a contingency for dropouts.
• Holistic data Predictive dosing enables a complete and more accurate picture of patient behavior and symptoms.

Time for some group problem solving! Delegates will be split into small groups and we will give you a nightmare scenario. Working together with your teammates, brainstorm ideas that can help you successfully overcome this stumbling block and ensure that the issue has the smallest possible impact on your resources and budget.

10 minutes will be given for each scenario, after which a spokesperson from each team will share your best ideas with the room before we move on to the next scenario.

‘Scenarios’ the groups will have to overcome include:

• Your CRO project manager has decided they want to take early retirement and move to Florida. What strategies do you need to put in place to ensure a seamless transition for your new PM? How would you go about finding the next perfect PM?
• Patients just aren’t interested in your study – recruitment is proving a struggle. How could you innovate your protocol and mix up your strategy to entice patients onto your study?
• Your competitor is launching a similar study to you. What should you do when negotiating with your preferred vendors and sites to ensure that your study is the one that is given their preference and their A-team?

This is a good opportunities for delegates to share their own experiences in problem solving and learn from each other’s ideas.

We are pleased to welcome X from Bristol-Myers Squibb to discuss how to ensure your business is inspection ready- no matter the region you are working with.  

• Ensuring that your teams have the correct training and that all necessary documentation is in place at all stages of your clinical trials
• Examining different regulatory bodies worldwide; what they expect to see and the differences between regional requirements. Includes a look at the regulatory bodies in the USA, Canada, Russia and others
• Tips on what your company can do to prepare and an overview of the main guidelines required in each region

• Learn about an innovative strategy that is changing the paradigm of clinical supply and medical procedure reimbursement
• Understand how this alternative strategy saves time, money, mitigates risks, and reduces reimbursement hassles
• Hear real-life case studies proving time and resource savings
• See how this efficient strategy compliments your decentralization efforts

In this session, we will debate the differences in approach to clinical trials that large and small pharma have and the pros and cons of each method. The format of the debate is as follows:

• Moderator opening remarks
• Initial audience vote
• Arguments For
• Arguments Against
• Interactive debate/Q&A
• Final audience vote

Our panelists will debate:

• Large pharma companies are better at picking up and adapting to new technologies
• Large pharma companies attract the best talent in terms of their employees
• Full service models (which are more likely to be used by larger companies) are the best at achieving results

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Don’t miss your chance to join the conversation!

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. This session will outline best practices learned over the past years in conducting global DCTs that should be considered to scale globally across complex regulatory landscapes.

Attendees will learn:

• How to identify and plan the initial studies for DCT approaches to scale
• Understand how to evaluate country-specific regulatory requirements and feature specific limitations
• Assess DCT providers for optimal capabilities related to integrations, technical helpdesk, device provisioning and multi-lingual support availability

• Can a small company handle specific requirements better than a large CRO? Identifying the pitfalls and weaknesses in your smaller suppliers – 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? Is this something that is riskier for small biotechs as they are more likely to be relying on one partner?
• 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?

Decentralizing clinical trials changes the factors driving patient burden by increasing the patient’s level of responsibility for accurate data collection. We’ll discuss the necessity of finding solutions that contribute to high quality data capture, compliance, and support to enable a better patient experience and achieve study success.

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Don’t miss your chance to join the conversation!

• Looking at RBx for Risk Based approaches to determine the quality, accuracy and integrity of clinical trial data.
• Discovering the ultimate tool kit for data management to ensure cost effective recording of data.
• Looking at TransCelerate tools and RBM methodology to help proactively manage emerging risks to better focus on patient safety and data quality.
• Meeting compliance through a preset, recognised model to avoid hitting roadblocks at “build-your-own” tools.

• Adopting Data Analytics software to help visualise data intelligently and allow access to data across different teams in a single location.
• Understanding block chain in both manual and electronic forms of data management to simplify processes and achieve reliable Clinical Trials assessment.
• Debating the need for eTools to identify trends and anomalies in data collection.
• Transitioning to eSystems to save time, better control data and obtain efficacy signals sooner.
• Developing eClinical and data strategies through cost effective tools to simplify and ensure more efficiency and compliance.
• Ensuring approved time frames and quality of data through correct training and / or electronic measurement tools to improve clinical trial outcomes.

• 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

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Don’t miss your chance to join the conversation!

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

• Leveraging Data Science teams to make an organisation data literate and upscale
• Identifying the value in a Data Science team to ensure cost effective processes and quality data
• Establishing and growing a Data Science team to be multi-disciplinary and globally efficient
• Developing strategic processes with a Data Science Team to ensure reliability and credibility of trial results
• Using technologies, AI and Data Analytics in conjunction with good clinical data practices to make fast and proficient decisions in the cycle of data collection

• 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

• Defining clear roles and developing smooth communication process between Operations and Clinical teams to ensure efficient data management
• Deciding on clear objectives based on hypothesis to streamline and future proof data
• Devising a thoughtful, upfront database build to decrease data cleaning time and increase data quality
• Developing a fluid process with outsourcing partners to ensure improved timeframes and data collection

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Don’t miss your chance to join the conversation!