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

• Accessing Australia’s ecosystem for early phase trials. A case study in how Australia’s generous 43.5% tax rebate and numerous skilled personnel make it the ideal environment for trials
• Accelerating patient recruitment in Asia for large complex trials
• The advantage of running global trials with regional CRO partners and the expertise they can offer

• 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

• 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.

• Designing your First in Human Trial
• What is a hybrid study
• What needs to be considered when running a hybrid study
• Case studies and leading examples on how to bring such studies into operations

By Celerion

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

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.

This session will focus on the current state of quality and provider oversight, synthesizing key insights from The Avoca Group’s 2019 industry research, and a vendor qualification study conducted in 2019 by the Tufts Center for the Study of Drug Development and The Avoca Group.

Learning Objectives:

• Utilization and perceptions of the effectiveness of oversight practices and approaches
• Approaches to and resources invested in clinical provider qualification
• Next-generation solutions to address the growing size and diversity of clinical trial service providers

This talk will focus on why we should be looking at the top of the patient recruitment funnel – why we should be targeting patients before they have even thought about joining our study – in order to more successfully recruit for trials. This new approach is vital as studies show we are failing at efficiently engaging patients – some experts claim we are still only reaching 10% of our potential pool of patients.

• Strategies for changing the public’s perception of clinical trials and how this can benefit all of us
• How we should be using social media and other tools to engage with your potential audience and encourage them to see you in a positive light
• What we can learn from the oil and gas industries – why are we seen as ‘greedier’ than them?!

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?

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.

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?

Data are generated at nearly every stage of the clinical trial life cycle, from collection of baseline subject data at enrollment to the analysis of the data set. Accessing meaningful subject data and obtaining insights into real- time engagement make a major difference between the probability of staying in treatment and discontinuation.

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

• 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

• Learn about an innovative and more efficient strategy that is changing the paradigm of clinical trial supply
• Understand how the alternative strategy saves time, money, mitigates risks and reduces clinical trial supply hassles
• Hear real-life case studies proving time and resource savings
• See how meeting the target “Study Start” and “First Patient In” date is more easily accomplished

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

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?

We are pleased to welcome Colleen Kostic 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

In this session we will discuss how to obtain high quality imaging data and the benefit the best possible imaging can have in evaluating, measuring and quantifying product effects

• Examining site set-up and qualification and the importance of choosing the right partner at the start of your trial
• Working with your Imaging partner, including phantom management and analysis of data
• The role that site-training and web-based training using services such as Litmos can help you get the best possible Imaging results

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

• 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?

Join Teckro as they discuss how to transform your protocol into valuable data for sites, monitors and sponsors.

How you can bring your study back into your control when things look like they’re going wrong based on the experience of mTem.

Including:

• What to do when relationships break down – steps you can take to monitor a CRO that you believe are not working to your standards and ensure that your trial is delivered successfully
• Working on your relationship with your CRO so that concerns can be raised before they have a chance to negatively impact your trial
• Best practices in re-monitoring your data if needed in order to ensure that the data you have received is reliable
• Dealing with high turnover of Project Managers – what negotiation strategies can we use to ensure that we are always getting the A-Team
• The steps we should all be taking to cover ourselves in case the worst should happen and we are let down by our CRO

We invite attendees to celebrate World Clinical Trials day by taking some time to reflect on why they got into clinical trials in the first place, what motivates you to do what you do, how your colleagues inspire you and your hopes for the future of healthcare.

Please do share your thoughts with your colleagues and write down any thoughts on the papers provided.

Our chairperson will gather up your notes and read them back to the room – a good opportunity to remind yourself of why we are all here working in this sector.

Join Bill Cooney, CEO of MedPoint as he discusses the Digital Document Ecosystem.

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?

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.

Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables.

Roundtable 1

Moving to an FSP Model – Examining When This is the Best Option For Your Study
Lynnette Etzel, Associate Director, Portfolio Sourcing and Relationship Management, Merck

Roundtable 2

Staff Retention – How You Keep Your Staff Happy, Encouraging a Low Turnover in Staff
 Alice Drumheller, Vice President of Clinical Operations, Sensei Bio

Roundtable 3

Examining the Sponsor-CRO-Site Relationship – Expectation Vs. Reality
Jigna Parekh, Senior Clinical Trial Manager, Incyte

Roundtable 4

Debating Best Practices to Achieve Successful Outsourcing of Data Cleaning
Lisa Squibb, Senior Associate Director Data Management, Boehringer Ingelheim

Roundtable 5

Leveraging Data to understand patterns, detect risk early and ensure proper oversight
 Timothy Koch, Global Head, Clinical Analytics, Novartis

Roundtable 6

Discussing proven methods for training CMs to successfully identify specific KRIs and modernise  Clinical Outcomes Assessments

Phi Tat, Central Monitor Manager, Pfizer

• 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.

• Defining the data manager role to ensure thorough data cleaning and recording
• Understanding metadata and clinical metrics to ensure effective, secure and accurate data collection and reporting
• Collaborating cross functionally to help develop and launch process improvements
• Supporting the data management process to ensure high data quality, efficient data process and smooth data flow
• Identifying trends from patient, study and country level to minimise time wasting and build better reports, faster

• 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.

• 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

• Transitioning from EDC to ESource to gather real time and true source data
• Analysing the challenges in the implementation of ESource to prepare for a risk-free approach
• Implementing EDairies and other Electronic Source Approaches to benefit patients, sites and sponsors
• Adopting the Esource approach to influence more efficient data gathering practices
• Embracing the digital revolution in clinical trials to enable smoother and more reliable data collection and management practices

• 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