Outsourcing in Clinical Trials Asia 2021

• Pinpointing experience as an essential element to scrutinize their capability to operate your trial successfully
• Recognizing soft skills such as time management and problem-solving competence as important When considering who should lead the trial
• Uncovering strategies for balancing time, quality and cost and how to achieve it by prioritising your needs

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

• The necessity for sponsors to have local clinical trials in countries where they tend to market the product
• The evidence would provide the confidence for healthcare professionals to prescribe the products
• The localized experience will boost patients to stick with the product

• The challenges of running successful trials in China can be daunting, and getting comparator sourcing right from the start is essential.
• This session will focus on the key areas for success as participants hear both the pharmaceutical and service provider views on how to navigate the Chinese landscape effectively.
• Join this session to find out more about overcoming these challenges and learn how making the right strategic choices can have a positive impact on running clinical trials in China.

• Considerations in clinical trials in India
• Challenges and Solutions in COVID19 Clinical Trials
• Requirements for determining clinical trials of start-ups

• Evolving Clinical Trial Logistics trends – Digitalization, sustainability and patient centricity
• Driving storage and transport efficiencies with an integrated regional distribution model to deliver seamless patient experience
• Increasing agility and reach with localized supply chain strategy for large domestic markets, taking a closer look into Australia, Japan and India

• Highlighting rising awareness of the major RBM pitfalls
• Utilizing advanced RBM models to improve data quality
• Leveraging experienced partners to RBM to ensure a best quality in your clinical trial
• Implementing technologies and setting expectations with the partner in RBM to make a smooth run of trial

• Implementing technology to maximise the value of RWD in your trials
• Navigating how early use of RWE can reduce Post market study costs and time-to-market
• Introducing the emerging applications of RWE that can increase trial research efficiency

• Addressing common events of temperature fluctuation during distribution and storage to understand the importance of real-time monitoring system
• Highlighting the significance of real-time online tracking tool to identify, trace, track, locate and protect perishable drugs on their journey through supply chain to provide immediate support to achieve high quality
• Examining best practices to monitor temperatures in difficult conditions to prepare for unexpected circumstances

• The IRT system plays an important role in patient randomization and inventory management. Despite the wider adoptions in recent years, Sponsors and CROs in APAC continue to face many challenges and obstacles when applying such technologies to manage their clinical trials.
• In this session, we will address some of these challenges (such as budget and resource constraints), recognize not all IRT solutions are the same, and why it make sense to adopt different IRT strategies depending on the specific needs of your clinical trial
• Almac’s newest offering, a configurable IRT solution (SimplifyTM), is designed specifically to address these challenges and the ever changing landscape of running clinical trials in APAC, especially in light of the trying time we are experiencing with the COVID-19 pandemic. As such, we will explore key benefits of this solution and how to make smart decisions when choosing an IRT solution.

• Describing the landscape in the biopharma’s current settings and exploring the areas where blockchain could be used
• Navigating blockchain approaches to address clinical trial management challenges
• Exploring how blockchain can be used for the design and implementation of faster, easier user identification processes

• The challenges of running successful trials in China can be daunting, and getting comparator sourcing right from the start is essential.
• This session will focus on the key areas for success as participants hear both the pharmaceutical and service provider views on how to navigate the Chinese landscape effectively.
• Join this session to find out more about overcoming these challenges and learn how making the right strategic choices can have a positive impact on running clinical trials in China.

• Considering what makes the delivery complex, including sensitivity, shelf-life and temperature control requirements
• Sharing key elements of how to successful delivery cell therapy products
• Presenting supply chain specific regulations to improve efficient supply distribution process and secure IPs in high quality

• Dramatically increasing demands of cold chain
• What is your challenges from this new trend?
• How to turn challenges into chances?

• IND Document preparation and approval procedure
• Exploring the impact of FDA requirements to conduct self-inspection and verification on clinical trial data
• Preparing communications with the inspector and pre-requisitions

• Overview and comparison of past and current dynamics of clinical outsourcing activities amid covid-19 situation
• Emerging trends and paradigm shift in outsourcing method
• Evolution of service provider selection strategy
• Use of digital techniques-platform and impact in decision making process

• Developing a clinical trial model that is able to withstand global disruption
• Switching gears: Should we be analyzing which parts of our clinical trials can go virtual?
• Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic

Future trials: Assessment of how upcoming clinical studies will be conducted in light of the pandemic and what the long-term effects will be

• Understand the purpose and value of a TMF
• Define what an inspection-ready TMF means to different regulatory bodies
• Evaluate how different regulatory agencies may interact with the TMF during an inspection
• Assess the current state of your TMF to determine how to achieve inspection-ready status
• Identify common areas of non-compliance

• Developing a clinical trial model that is able to withstand global disruption
• Switching gears: Should we be analyzing which parts of our clinical trials can go virtual?
• Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic

Future trials: Assessment of how upcoming clinical studies will be conducted in light of the pandemic and what the long-term effects will be