Contract Pharma: What do you see as the greatest motivators for outsourcing in today’s market? 
 
Jeff James, Executive Vice President, Alliance Management, ICON
The clinical research industry has undergone transformational changes in the last 10 years as it has matured and consolidated. This accelerating change has brought new outsourcing models and operational strategies driven by an increasingly prevalent partnership imperative between large pharmaceutical companies and contract research organisations (CROs). More than ever before, the success of an organizational strategy is tied to a shared partnership culture. 
 
Where outsourcing used to be a decision between full-service outsourcing (FSO) and functional service provision (FSP) models, blended and hybrid models are increasingly common. A blended model allows for harmonized portfolio SOPs, systems, and processes and can be tailor-fit to each sponsor or project. Strategic partnerships and blended outsourcing allow sponsors and CROs to engage more tactically, providing tailored models depending on the sponsor’s specific configuration, capacity and desired outcomes. Different models or different versions of a blended model can be employed across the CRO-sponsor relationship. However, these flexible, tailored models require additional emphasis on partnership and cultural alignment. 
 
As we leverage more of the spectrum of operational and outsourcing strategies, from both full-service to functional, from a single study to a portfolio, and from regional to global, we add layers of complexity. As complexity increases within the industry, trusted partnership is vital to the success of the operative outsourcing models. Understanding the models themselves is crucial for the initial decision-making, but a holistic strategy will also account for the cultural component. 
 
Contract Pharma:  In what service areas do you see the most demand? 
 
Harpreet Gill Head of Decentralized Clinical Trial Solutions, ICON
Decentralized clinical trial services, focused on the patient, are continuing to grow in importance and is one area where we are seeing increased interest from customers. Associated with this is the demand to deliver these services in a way that increases patient participation and engagement, reduces patient burden, improving diversity and inclusion, and ultimately leading to faster time to bring treatments to market.  

There are some basic fundamentals and services in ensuring the technology used to deliver decentralized clinical trials is truly patient centric which include; consultancy on ensuring the study design and technology interaction is developed to reduce rather than increase patient burden, ensuring patients have optionality in how to engage in the clinical trial, be it remotely through digital health technologies (DHTs), data capture at in-home visits or both, and most importantly, providing appropriate technical and protocol adherence support. We are seeing significant interest in our in-house Concierge Services that can help with scheduling, welcoming patients, responding to patient queries, collecting reported events, and provisioning and retrieving DHT devices, all of which increase patient satisfaction leading to higher retention, to avoid trial delays. 
 
If executed in the right way with the right support to patients and sites, the digitalization of clinical trials has the potential to really shift trials to be more patient centric. 
 
Contract Pharma: What role does technology and regulatory frameworks play in outsourcing today?
 
Tom O’Leary, Chief Information Officer, ICON
Both technology and regulatory frameworks play an integral role in outsourcing. Post the COVID-19 pandemic there has been a significant increase on the regulatory aspect of outsourcing, with particular focus on the level of operational resilience to ensure firms have the appropriate arrangements in place to reduce the risk of operational disruption resulting in negative impact to customers and/or the wider market as a result of outsourcing arrangements. 

The life sciences sector proved itself to be particularly resilient in this regard and virtualized much of the ways in which clinical trials were conducted. This resulted in a decentralized clinical trial delivery model being firmly established.
 
Data has also become a fundamental consideration in all outsourcing arrangements – ensuring the organization that is processing the data has all the necessary infrastructure and capabilities to support the General Data Protection Regulation is a fundamental.
 
Lastly, ensuring organizations have a robust cybersecurity capability to protect the technology and data that are utilised in the context of drug and device development is key. When outsourcing services it is critical to understand whether any key security obligations flow down the supply chain. Key suppliers and vendors may hold important data – having access to critical IT infrastructure and ensuring companies maintain appropriate technical and organisational measure in this context are key. 

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