Small and medium-sized enterprises are always looking for ways to run effective trials at a reasonable cost. It has become a high priority for sponsors to set up efficient clinical trials, especially when collaborating with outsourced companies.
However, improving efficiency is also not just something that will save a sponsor. It additionally bodes to improve patient retention and site cooperation while speeding up trials to get drugs to market quicker.
Go deeper with GlobalData
Arena International’s Outsourcing in Clinical Trials (OCT) West Coast 2025 conference will bring together industry professionals at the Hyatt Regency San Francisco Airport on 11-12 February to discuss a number of the recent advances in the industry and the changes that experts are anticipating over the next few years.
The conference will have four streams running over the two days. The Outsourcing and Clinical Operations, and Clinical Innovation and Technology streams will both run across both days of the conference. The Patient Engagement with Diversity and Inclusion stream will run on 11 February and a Medical Devices stream will run on 12 February.
Improving efficiency – saves time and cash
The conference will open with a keynote from RenovoRx’s chief clinical officer Leesa Gentry about optimising efficiencies at clinical trial sites when they are underperforming.
Speaking ahead of the event, Gentry said: “Clinical trial sites do not need us as much as we need them. To the best of our ability, we need to try to work within a framework that makes it easier for sites to be efficient. We also need to make sure that those protocols are set within the constraints of the site’s own processes whenever possible instead of a blanket process across an entire trial. We need to think global but act local. Try to use the local requirements as an advantage, instead of making it a disadvantage, and try to bridge the gap from a more personal level.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataOther sessions on efficiency will also be heard, including a session about innovating data in life sciences, how AI is transforming healthcare and how contract research organisations (CROs) can bolster strategies to improve efficiency while maintaining quality.
Gentry adds: “AI is going to be pervasive in every aspect of our industry in the future. We certainly have not yet figured out how to use AI and harness its value to the extent that we can, but I do think there are a lot of groups that are working on that. Efficiency is certainly the low-hanging fruit for AI – being able to generate documents quickly and cross-referencing documents to aid in the regulatory approval process – those tasks are all going to be aided by AI.”
Regulatory and political shifts also on the agenda
As the US welcomes returning President Donald Trump, the industry is preparing for changes. On Tuesday, a session entitled “The 2025 Biotech Landscape: Perspectives and Projections” will be hosted by Aditya Kotta, head of business development US and EU at Novotech. The session will look at trends observed during the JP Morgan Healthcare 2025 conference and the impact of the new administration on clinical trials.
Katie Bessette, head of regulatory affairs at Abbott, will run a session on recent FDA guidance on clinical research topics and what it means to those in the sector. Topics of conversation will include waiving consent forms when needed, how to ensure that informed consent forms include key information and ways to implement decentralised clinical trial elements to improve trial patient engagement, recruitment, enrolment, and retention.
Diversity in clinical trials on a global scale
On 12 February, Archana Sah, founder of AS Pharma Advisors and oncology board member for the Society for Clinical Research Sites, plans to examine the World Health Organization’s (WHO’s) recently released guidance on best practices for clinical trials to enhance the efficiency and credibility of clinical research. The session will delve into the guidance and the best practices for sponsors to incorporate into their trial design to improve the diversity of patients while collecting data that will later be supported by regulators.
There will be questions about how US companies will take on this guidance given Trump’s executive order to remove the US from the WHO. Speaking ahead of the conference, Sah explains: “The clinical trial ecosystem pillars as outlined in the WHO guidance have cross-cutting themes of patient and community engagement, collaboration, coordination and networking, use of common systems and standards, training and mentoring, risk-proportionate efficient approaches, sustainability, innovation and transparency.
“These will continue to exist as the pharma industry will play the long game of executing global trials and seeing these pillars as value drivers for innovation and access to diverse patients globally.”
Other sessions focusing on diversity will include whether clinical trial exclusion criteria are too stringent and how the FDA’s recent directives will impact representation in trials.
Patient-centricity key to improving clinical trial retention
One of the key ways to improve patient engagement, recruitment, enrolment, and retention is running more patient-centric studies – especially in rare diseases.
Sah added: “In my opinion, the true definition of patient centricity is thinking about the patient throughout the patient journey as you’re designing the protocol. This continuum ranges from the prevalence of the disease (pre-screening), screening, enrollment, follow up and even monitoring post-follow-up as well.
“It is important that protocols are designed with digital and decentralised tools that enable taking the trials to where the patients reside in the community/rural settings. An often overlooked factor but vitally important is to make sure the protocols are practical, executable and in concordance with the clinic workflow and avoid a high burden on sites to execute them.”
One session will look at the benefits of building trials focused on patients and delivered in their community, presented by Catherine Jervis, general manager of integrated solutions at clinical trial support company MRN [Medical Research Network]. Other sessions will look at how the patient’s voice needs to begin from informed consent forms, with another looking at how sponsors can collaborate with CROs to build more patient-centric trials.
On day one, Nisha Trivedi, a rare disease patient advocate, will discuss their clinical trial journey in two hybrid studies and what worked well during these studies. She will also highlight areas of improvement from these studies, before providing recommendations for ensuring patient-centric trial design.
