Outsourcing in Clinical Trials Southeast 2020

• Utilizing various methods of patient engagement such as apps, websites and text messages to ensure the patient is well informed throughout trial
• Easing the financial burden of trial on patients due to traveling by utilizing decentralized methods to encourage participation from early stages to completion
• Understanding the importance of ensuring diversity within trials to ensure inclusion of patients from various backgrounds
• The importance of technology in fostering a more patient minded approach to clinical trials by allowing decentralization of the clinical trial process

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

• Looking at methods of ensuring success when applying for grants by showcasing the aspects of your trial that will differentiate your proposal from the rest
• Looking at various methods of funding such as grants and private investors to decide which is the best fit
• Navigating the politics of the review process when applying for grants when the FDA and review board have conflicting feedback
• What to do if you have been turned down for a grant; navigating the appeals process

• Ensuring the clinical data management plan outlines all aspects of CDM management
• Fostering early communication between the sponsor and CRO to ensure any CRF design changes and protocol amendments are addressed and understood to ensure they consistently align throughout the trial
• Ensuring an adequate data review plan is available to ensure anomalies are found prior to data lock
• Understanding how to utilize eSource Direct Data Capture (DDC) in your study for direct data capture

• Working with CROs to ensure they are able to meet the project specifications by the specified timelines by ensuring the initial contract is clear and concise
• Asking CROs for recommendations on how to handle certain issues within trials during RFP process to ascertain the compatibility between their chosen methods of progressing and the trial sponsors expectations
• Creating strong terms during contracting to limit the change orders which will lead to less ambiguity in costs associated with each step
• Crossing into global trial execution and ensuring clear agreements that meet regional requirements which will uphold governmental and internal review board scrutiny

• Looking at the role leadership plays in the success of various trial aspects
• Incentivising team members to control the time/cost/quality during the clinical trial process
• Fostering deeper communication by looking at personal means of contact rather than e-mail
• Looking at the physiological benefits of promoting a space that encourages the ‘freedom of mistakes’ to ensure small issues will not snowball

Technology Afternoon

As innovation and technology take a hold of our everyday lives, the pressure for the pharma and biotech industry to adapt and integrate these new methods into trials have become further prevalent with each passing year. This afternoon will not only look at cost effective way to integrate new tech into trials but also look at the question of whether this tech is necessary or not.

This talk looks 10 years into the future when clinical trials are driven by many AI processes including

• Using AI to enroll a trial based on EMR and genomics
• Using AI to design adaptive and patient segmented clinical trials
• Using AI to deliver the trial to the patient, manage compliance and track results
• Using AI for poly pharmacy based trials

• Using virtual trials to access patients that would not be able to conventionally travel to an site
• Ensuring the use of ePro systems will not affect the time lines of trials due to issues with initial programming
• Finding the right balance between utilizing technology to achieve decentralization in trials while maintaining oversight of the integrity of the data
• Navigating regulations and data protection laws when looking to expand virtual trials to a global scale

• A brief overview of the current landscape and direction of novel oncology therapies
• Evaluating & selecting the optimum trial design for targeted therapies such as immunotherapy, monoclonal antibodies, and gene therapy
• Feasibility considerations, including advancements in resourcing and technology to help find and recruit patients
• The importance of biomarkers and companion diagnostics play in the development of targeted therapies

• Utilizing an electronic TMF to effectively oversee the trial to foster accountability
• Telecommunication as a tool to encourage real time dialogue to establish deeper connections between sponsors and providers
• Open technology standards and their ability to decrease overall trial timelines for trials by allowing the direct transfer of data and milestones from CRO to sponsor
• Choosing the correct analytical overlay to allow easy digestion of data being transmitted

Delegates will form small groups for an interactive session solving some of the issues that can be seen when integrating technology into trials. Each group will be given 10 minutes to brainstorm solutions to crisis situations to look for ideas that will cause the least disruption to the overall integrity of the trial. The scenarios will be revealed at the session to encourage ‘on-the-spot’ solutions.

• Understanding the gaps in oversight from off-site trials and looking at the best ways to overcome these especially in gene or cell therapy trials
• Ensuring the data collected from patients is reliable and are not being ‘fudged’
• Choosing sites equipped with managing the collection of sensitive material such as LabCorp to decrease trial costs
• Looking at the impact a decentralized trial would have on the investigator ensure the large caseloads do not interfere with the integrity of the trial

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.

RT1
The role of patient registries to assess safety risks in clinical trials Joy Carson,
Vice President, Clinical Operations & Development AskBio

RT2
Matchmaking between CRO’s & trial sponsors to find the right fit for your study Chris Warner
Lexicon Pharmaceuticals

RT3
Techniques for streamlining reporting in order to comply with FDA regulations Michael Mclaughlin
Associate Director, Clinical Operations Dermavant Sciences

RT4
Methods for strong contract negotiation to improve overall trial experience Chad Whittaker
Associate Director, Business Operations& Program Management, Aerami

• Overview of GDPR Framework and the challenges for life science companies big and small
• Sponsor/ data controller responsibilities when considering CRO data processor third party preferred vendors
• IT/ Technology security standards and compliance monitoring for sponsors and outsourced partners
• Understanding the difference between informed consent (IC) and the legal basis under the GDPR for processing personal data

• The importance of face to face conversations to foster a reputation with vendors and sites as a means of ensuring the correct attention is paid to the study
• Utilizing the Trial Steering Committee’s involvement to offer recommendations to get the trial back on track
• How program management skills played a role in ensuring the trial is being running correctly and there is adequate leadership guidance
• When to rely on supplemental outsourcing methods to bring life back into the study

• Recognizing red flags during the bid defence meeting for early detection of possible issues that may arise in CRO relationships
• Techniques for establishing clear KPI’s and deadlines that are consistently followed through to ensure study deadlines are met
• How to get back on track when vendor obligations are not being met
• Assessing issues that arise during trial from both CRO & sponsors point of view to ensure future trials have less change orders after initial contract negotiation

• Choosing the correct transportation couriers when running a global trial that requires cryogenic storage to ensure the integrity of the product
• Understanding embargo treaties with targeted countries to ensure the timely delivery of biological materials
• Easing the transportation burden on patients in remote locations to ensure the quality of the IMP is not compromised during travel from site to patients home
• Meeting QA standards when transporting temperature sensitive materials from site to patient

• Ensuring effective monitoring of the vendors ability to meet contractual obligations
• Following the FDA’s 3 step approach to RBM; detecting the critical data points and processes, preforming risk assessments and developing a monitoring plan
• Applying a risk threshold while ensuring enough data is reviewed that confidence in the final product is unwavering
• Choosing the correct RBM strategy to apply to your trial to reduce the time to approval for INDs

• Choosing a CRO with a level of expertise needed to conduct specialized trials within needed time parameters
• Ensuring the integrity of the target therapies is not compromised during transport by understanding the best couriers and storage to use for temperature & time sensitive materials
• Targeting the correct patient populations to meet enrollment requirements for specialized trials
• Methods of long term monitoring of patients to monitor efficacy of IMP

• Choosing which hybrid model to utilize in your trial dependent on in-house capabilities
• Ensuring a clear SoP is utilized across all vendors to enable ease of FDA auditing with limited resources
• Cost effective ways of outsourcing specific portions of a study to regional CRAs
• Methods of managing and organizing contracts to maintain oversight over vendors ability to meet contractual obligations

• Understanding the best ways of reaching diverse populations such as the LBTGQ community
• Utilizing decentralized trials to create an environment that allows patients to participate in clinical trials without needing to physically go to a site
• Ensuring the population understands procedures terms as informed consent to allow them to feel comfortable with participating in studies
• Looking at new methods of reaching a wider patient population such as social media