Outsourcing in Clinical Trials Southeast 2021 - Virtual Conference

• 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

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

• 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

• Historical review on the diversity in clinical trials
• Overview of the recent FDA guidance document on the enhancement of diversity in clinical trial populations
• The importance of diversity in patient populations, including some recent examples
• How to impact equity in clinical research
• What else can we be doing to effect change?

• 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

Implementing change is not easy; and shifting towards emerging trial designs can be a huge hurdle for your study teams. Learn how PRA is approaching DCTs and CRAACO and hear case studies and key considerations

• Considerations for building and implementing your first (or upcoming) Decentralized Clinical Trial (DCT)
• Understanding how Clinical Research as a Care Option (CRAACO) will impact clinical trial operations
• Example of digital Health technologies enabling DTx

• History of data protection in EU
• GDPR impact + BREXIT Impacts
• Data Protection – clinical research scope
• The 9 implementation steps to Success
• GDPR: risks and their sources
• Benefit of GDPR

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

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

• Improved data quality and study efficiency through consistency and clear messaging
• Simplifying protocols by aiding authors in staying focused on the key objectives for ultimate registration goals
• Long term gains by getting it right at the start

• Enhance clinical trial tracking / authentication allows accurate clinical trial supplies and events forecasting by implementing blockchain technologies in the drug development
• Blockchain assures data confidence for artificial intelligence, deep data mining, internet of things, and decentralized trials to be implemented as the emerging healthcare technologies
• The only true risk in blockchain adoption is actually being ‘risk adverse’ when implementing this disruptive technology

• 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

• 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

• The Validation Plan explained- how the IRT team validates the system
• Interpreting the system requirements for the purpose of UAT
• Generating UAT test scripts that can benefit your study
• Establishing comprehensive documentation that will pass an audit

• Identification of fit for purpose vendors, and driving a productive RFP pathway to award.
• Working with CROs & Vendors to ensure they are able to meet project specifications and within specified timelines/budget.  Balancing sponsor strategies with service provider expertise/recommendations.
• Initial contracting considerations and pitfalls – avoiding misalignment and managing uncertainty.
• Creating appropriate terms during contracting to limit change orders and foster transparency.
• Crossing into global trial execution and ensuring clear agreements that meet regional requirements which will uphold governmental and internal review board scrutiny.
• Measuring success and transparent closeout.

• 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 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 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