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<v Speaker 1>All right on. Our next presenter will be discussing insights

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<v Speaker 1>from TOUGH Center for the Study of Drug Development into

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<v Speaker 1>evolving trial partnerships models. Please join me in welcoming the

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<v Speaker 1>amazing Joane Chambers.

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<v Speaker 3>So what a.

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<v Speaker 2>Great attendance for this inaugural summit. And it's very nice

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<v Speaker 2>to see so many familiar and friendly faces and to

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<v Speaker 2>also meet some new people. So good afternoon. Hopefully everyone

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<v Speaker 2>is still awake, you're not coming off that sugar high.

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<v Speaker 2>But I just want to say thank you for the

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<v Speaker 2>opportunity to share insights on the evolving global investigative site

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<v Speaker 2>landscape at the Partnerships with Site Summit. I will be

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<v Speaker 2>referencing my notes just to ensure that I stay on time.

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<v Speaker 3>I have fifteen minutes.

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<v Speaker 2>I have a lot of great information to share, insights

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<v Speaker 2>and some data. A copy of the slides will be

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<v Speaker 2>available after the summit, so if you want to take

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<v Speaker 2>pictures of the slides, you're more than happy, but there

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<v Speaker 2>will be a copy sent to everyone. As I prepared

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<v Speaker 2>for this presentation, I reflected on the goal of this

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<v Speaker 2>event to discuss, share and learn how pharma, biotech and

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<v Speaker 2>CROs can be better partners with investigative sites, and this

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<v Speaker 2>has been a longstanding challenge in our industry and remains

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<v Speaker 2>just as relevant today. So far, in my opinion and

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<v Speaker 2>hopefully you agree, we've heard some really excellent presentations and

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<v Speaker 2>panels on strengthening biopharma cro site partnerships, bridging the gaps,

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<v Speaker 2>improving and streamlining communications. A common theme that we heard

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<v Speaker 2>navigating consolidations and industry disruptions, leveraging technology to boost patient

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<v Speaker 2>recruitment and retention, and improving study conduct and management. And

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<v Speaker 2>so when I stepped back and when I heard a

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<v Speaker 2>lot of these common things teams this morning, my talk

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<v Speaker 2>today will focus on the trends and insights shaping the

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<v Speaker 2>site landscape, including investment interest and the importance of close

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<v Speaker 2>collaboration between sponsors, CROs and sites to make clinical trials

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<v Speaker 2>more accessible and convenient for patients. We all know and

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<v Speaker 2>we heard this just recently. One approach doesn't fit every

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<v Speaker 2>single study, and at the same time, we must rethink

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<v Speaker 2>how we conduct and manage trials across the industry, always

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<v Speaker 2>keeping the patients safety front and center. So with this introduction,

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<v Speaker 2>oh where's the clicker?

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<v Speaker 1>Oh?

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<v Speaker 3>So with this introduction, I'd like to just do a

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<v Speaker 3>really brief.

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<v Speaker 2>Introduction to the TOUGH Center for the Study of Drug Development.

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<v Speaker 2>Next year, TOUGH CSDD will celebrate fifty years as an

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<v Speaker 2>independent academic group at the Tufts University School of Medicine

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<v Speaker 2>based in Boston, Massachusetts. Over this time, the team has

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<v Speaker 2>conducted data driven research that supports drug development and provides

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<v Speaker 2>clinical provides critical insights for stakeholders across government, industry, and academia.

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<v Speaker 2>This afternoon, I will cover industry insights or perspective on

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<v Speaker 2>the global investigative site landscape with new clinical trial execution

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<v Speaker 2>models emerging and through these new models, creating a roadmap

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<v Speaker 2>for increased consolidation, centralization and accessibility for clinical trial participation,

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<v Speaker 2>for the participants and for the communities.

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<v Speaker 3>A few key areas of focus.

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<v Speaker 2>I'd like to highlight on this slide because I know

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<v Speaker 2>that there's a lot of information that really reinforces the

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<v Speaker 2>theme of this summit clinical trial success hinges on patient

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<v Speaker 2>recruitment and retention. Only two to five percent of US

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<v Speaker 2>patients are enrolling in trials and just twenty seven percent

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<v Speaker 2>of screen participants meet the eligibility criteria. Patients are central

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<v Speaker 2>to clinical trials. We are hearing this theme throughout today

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<v Speaker 2>investigative sites have the direct contact with patients and are

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<v Speaker 2>known as the trusted partner, and yet all industry stakeholders

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<v Speaker 2>are faced with the key patient participation burdens. Today, there's

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<v Speaker 2>a growing demand for clinical trials that are more accessible, convenient,

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<v Speaker 2>and flexible for participants, and while this is true for

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<v Speaker 2>some studies, it's not universal. In response, new site execution

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<v Speaker 2>models have emerged, including site staff embedded in clinical care settings,

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<v Speaker 2>home health services, and many more, as you can see

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<v Speaker 2>on this slide. At the same time, site networks and

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<v Speaker 2>academic institutions have grown to meet this demand. Larger private

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<v Speaker 2>site networks are attracting investment and capital markets are backing

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<v Speaker 2>roll up strategies and new models, and this is leading

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<v Speaker 2>companies to rethink site use as well as study execution.

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<v Speaker 2>How is the site landscape shifting with these new execution

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<v Speaker 2>models and where is where is the investment flowing. This

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<v Speaker 2>section that i'll next present explores how clinical trial insights,

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<v Speaker 2>growing capital interest, and new technologies like DCT solutions are

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<v Speaker 2>driving centralization, efficiency and accessibility. In order to keep pace,

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<v Speaker 2>we must really rethink how trials are being conducted, something

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<v Speaker 2>very different from thirty years ago, and again we heard

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<v Speaker 2>that kind of common theme from this morning through this afternoon.

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<v Speaker 2>From nineteen eighty to twenty ten, the clinical trial landscape

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<v Speaker 2>was relatively straightforward, with six primary site execution models really

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<v Speaker 2>shaping trial management and patient outreach. This chart shows how

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<v Speaker 2>a site distribution has changed over time from two thousand

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<v Speaker 2>to twenty twelve, the six primary site execution models really

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<v Speaker 2>dominate it as we saw on the previous slide. Between

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<v Speaker 2>twenty twelve and twenty twenty four we see a more

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<v Speaker 2>diverse mix of models, with a slight uptick increase in

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<v Speaker 2>sites in Asia, increasing and expanding global access to clinical trials.

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<v Speaker 2>We all know the site landscape is shifting. More sites

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<v Speaker 2>are handling multiple filings across different trial settings. This growth,

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<v Speaker 2>especially among AMCs and hospitals and your dedicated sites, opens

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<v Speaker 2>the doors for organizations to scale run trials more efficiently

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<v Speaker 2>and diversify their portfolios. And these trends could reshape trial

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<v Speaker 2>management and expand the site capacity to meet the growing demand.

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<v Speaker 3>Today.

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<v Speaker 2>Sorry Today, various site execution models aim to improve patient

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<v Speaker 2>accessibility and operational efficiency in clinical trials. So again, back

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<v Speaker 2>in the nineteen eighties we had six. Now we have

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<v Speaker 2>a wide array of different site execution models, but again

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<v Speaker 2>not one size fits all solution. And additionally, with these

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<v Speaker 2>different types of models, what will each relationship look like?

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<v Speaker 2>With biopharma and CROs. Over the past decade, protocol designs

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<v Speaker 2>have become even more customized. Endpoints, procedures, and planned visits

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<v Speaker 2>have all increased across phases one, two, and three. In

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<v Speaker 2>Phase three especially, the burden on patients and sites has grown.

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<v Speaker 2>Patients face more visits and procedures while sites are managing

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<v Speaker 2>more tasks. Additionally, expanding into more countries and having sites

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<v Speaker 2>add to this level of complexity, so the impact is

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<v Speaker 2>really clear. Trials run longer, they face more amendments, and

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<v Speaker 2>see higher dropout rates, all signs of the rising burden

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<v Speaker 2>on the patients.

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<v Speaker 3>As we move forward.

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<v Speaker 2>Let's take a look at overall trial duration by phase

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<v Speaker 2>from twenty eighteen to twenty twenty one. Phase one trials

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<v Speaker 2>averaged one year and eight months, while phases two and

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<v Speaker 2>three each took more than three years from protocol approval

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<v Speaker 2>to actual databaselock. There's a high coefficient, a variation that

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<v Speaker 2>reflects difficulty in predicting timelines and more protocol deviations. And

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<v Speaker 2>then when we look at phase one. The high variance

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<v Speaker 2>stems from the mix of complex diseases and trials and

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<v Speaker 2>more traditional studies. Key reasons, as we're probably all very

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<v Speaker 2>much aware, but nicely to be reinforced. Key reasons that

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<v Speaker 2>pay choose not to participate based on informed consent reviews

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<v Speaker 2>include the burden of participant, the burden of participation, scientific

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<v Speaker 2>or study related insufficient information and privacy or confidentially concerns

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<v Speaker 2>participant feedback, and adds other challenges regarding the uncertainty about

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<v Speaker 2>receiving the investigational treatment. What's key here is the research

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<v Speaker 2>center location and long study visits and large site networks

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<v Speaker 2>in site management organizations help reduce patient burden by making

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<v Speaker 2>studies more accessible and convenient. They streamline the operations, They

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<v Speaker 2>improve the scheduling. They strengthen the communication to address the

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<v Speaker 2>concerns about the research location, about the timing, and the procedures.

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<v Speaker 2>This approach may also ease the anxiety about risks and

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<v Speaker 2>the treatment. Transparency. Transparency another word that we've heard today

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<v Speaker 2>supporting stronger engagement and smoother participation. Since twenty twenty one,

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<v Speaker 2>sponsors and CROs have increasingly relied on SMOs for their

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<v Speaker 2>later stage trials. While Phase three studies have actually doubled

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<v Speaker 2>by twenty twenty three and Phase two usage more than doubling,

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<v Speaker 2>highlighting the smo's growing role in managing larger, more complex studies.

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<v Speaker 2>Since twenty sixteen, investors including private equity, venture capital, and corporations,

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<v Speaker 2>have been building multi site research networks, and these networks

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<v Speaker 2>benefit from technology standardization and centralized operations areas where investors can.

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<v Speaker 3>Add the real value.

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<v Speaker 2>Investor support has also grown steadily in Sponsors are increasingly

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<v Speaker 2>evaluating the quality of sites that are receiving this type

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<v Speaker 2>of backing. As as institutional interest in clinical research grows,

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<v Speaker 2>financial investors are increasingly driving site consolidation. This trend is

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<v Speaker 2>evident in this chart that we see here. In twenty

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<v Speaker 2>twenty three, thirty four financial investors acted as a majority

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<v Speaker 2>or a lead investor in site networks, compared with just

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<v Speaker 2>three in twenty fifteen. This year, the Tought Center launched

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<v Speaker 2>a study on the changing global investigative site landscape. We

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<v Speaker 2>looked at how organizations are working with different site models

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<v Speaker 2>and how clinical child networks are growing and evolving. We

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<v Speaker 2>had a working group of pharma companies biotech companies in

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<v Speaker 2>one cro provide funding for this study. When we met

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<v Speaker 2>it was very challenging for the entire group to really

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<v Speaker 2>identify all the different site types and the definitions. So

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<v Speaker 2>based on this study, we came up with these three

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<v Speaker 2>in order for the sites to self identify themselves.

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<v Speaker 3>One are you an.

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<v Speaker 2>Academic medical center or a health system? Two are you

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<v Speaker 2>community based for profit site?

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<v Speaker 3>Network?

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<v Speaker 2>And three independent community based for profit site but you

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<v Speaker 2>are not affiliated with a network. So the next few

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<v Speaker 2>slides just really show highlights of this study. We're still

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<v Speaker 2>also in the midst of analyzing some of the data,

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<v Speaker 2>so from the survey that we sent out to global sites,

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<v Speaker 2>we asked how the sites are funded and owned. As expected,

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<v Speaker 2>we see that for profit networks rely on private equity

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<v Speaker 2>and investors. But what caught our attention in the study

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<v Speaker 2>and the data was what sites across the three segments

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<v Speaker 2>listed their funding as either individual or not individually or corporate.

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<v Speaker 2>Looking at it from a study conduct phase, we see

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<v Speaker 2>that across these across the site execution models, the study

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<v Speaker 2>conduct phase was relatively consistent. Our working group wanted to

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<v Speaker 2>understand where patients live in relation to the study site.

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<v Speaker 2>This slide shows that similar percentages of patients participate in

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<v Speaker 2>trials within a one to ten mile or eleven to

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<v Speaker 2>fifty mile from home. We added kilometers because some of

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<v Speaker 2>our global sponsors of the working group were based internationally,

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<v Speaker 2>and then we also saw that some other patients were

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<v Speaker 2>in other comparable distant areas. Additionally, we wanted to take

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<v Speaker 2>a look at public transportation, so public transportation from participants'

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<v Speaker 2>homes to the site was actually limited, according to the

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<v Speaker 2>several research centers that replied to the survey. Again looking

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<v Speaker 2>at that accessibility, the flexibility and the convenience for participants

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<v Speaker 2>to join a clinical trial. Each site model uses DCT

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<v Speaker 2>elements to make childs more accessible and flexible from the information.

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<v Speaker 2>ECOA conducted at the patient's home is common in community

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<v Speaker 2>based for profit sites, while your site networks and AMCs

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<v Speaker 2>affiliated centers deploy a broader mix across apps, telehealth, wearables,

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<v Speaker 2>and web portals others that are.

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<v Speaker 3>Backed by funding.

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<v Speaker 2>The views on expected use of technology was generally consistent

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<v Speaker 2>across AMC's and affiliated centers and the site networks in

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<v Speaker 2>the area that technology will improve data quality and integrity.

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<v Speaker 2>Other areas showing strong alignment across the models, including providing

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<v Speaker 2>faster enrollment recruitment and lead to greater trial efficiency. This

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<v Speaker 2>slide shows how alternative visit locations are used across different

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<v Speaker 2>sites types. The beige areas that you see highlight. It

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<v Speaker 2>represent the percentage of trials using these types of different

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<v Speaker 2>locations and the actual providers whether it was a mix

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<v Speaker 2>of a sponsor, ro or site or combination, and the

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<v Speaker 2>slide actually reveals how the adoption varies across a different landscape.

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<v Speaker 2>It was insightful to see how each group ranked the

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<v Speaker 2>top five challenges in clinical research. This is my last

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<v Speaker 2>slide for these challenges which we heard this morning in

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<v Speaker 2>the panel discussions communication protocol complexity, patient access, and staff turnover.

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<v Speaker 2>The fifth profit pressure primarily affects privately backed site networks.

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<v Speaker 2>I do have closing remarks. I'm just going to make

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<v Speaker 2>this one comment. Strong partnerships today are what will shape

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<v Speaker 2>the trials of tomorrow.

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<v Speaker 3>Thank you very much,