Welcome to the March issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
A career in clinical research was not on Charlie Jordan’s radar coming out of college; he was a history major and had a different professional path in mind. However, his job search led him to pursue accounting work at PMG Research and, like many others, he tumbled into the clinical research industry and fell in love with it.
Clinical studies have to be closed out eventually, and this is where Charlie started his career. As he gained proficiency in study close-out, he helped the site switch from cash to accrual accounting, refine how they recognize revenue, and better understand their accounts receivable. As he learned more about what is required to bring a clinical study to fruition, Charlie developed an interest in areas extending beyond the financials. “By managing the finances of clinical studies, I became more familiar with what is required to negotiate a clinical trial agreement (CTA) and a budget within a CTA,” Charlie said. He spent two years as PMG’s primary budget negotiator.
Charlie’s interests extended still further. Known for his friendly demeanor at PMG, he wanted to engage in some of the outward-facing work to improve communication practices with the site’s sponsor partners. “I wanted to be able to work on building these relationships from the ground up so that when issues arise, sponsors knew exactly who to call to navigate the issue,” Charlie said. Poor communication has been identified as one of sites’ primary pain points, so attention to the quality and consistency of communication is vital. By delineating a primary contact, PMG Research was able to begin the process of decreasing study start-up timelines and navigating issues as soon as they were identified.
Charlie has been the manager of business development at PMG Research for almost two years. In this role, he is able to focus on both sponsor negotiations and communication. “The start-up process has the potential to be streamlined, but it is often one of the biggest elements that holds us back from study success,” he shared. Delayed study start-up often results in hundreds of thousands – if not millions – of dollars in delays, and while site employees are very capable, no employee is able to maximize their effectiveness by working as fast as possible to meet deadlines. “We cannot improve the start-up process without bringing focus to managing our relationship with sponsors,” Charlie said. Sites are highly motivated to work quickly, but when sponsors tell sites that they are not working fast enough, the quality of work suffers and it becomes impossible to think smarter about start-up processes.
“I see my job less as finding one particular study for the company, and more about talking with the sponsors we work with the most to determine how satisfied they are with the quality of work we provide and how we can build upon that,” Charlie commented. “Sponsors that have demonstrated commitment to timely and efficient study start-up are willing to have conversations that might extend beyond the normal scope. When these conversations happen early on in the study process, all involved end up benefiting.” To date, Charlie has been able to facilitate increased quality in relationships with five primary sponsors that PMG Research works with. As a result, both the sponsor and the site are able to utilize candid feedback to adjust protocols and approaches as needed. “We all benefit,” he said, “including the patients.”
“Clinical research as a care option is our mantra at PMG,” said Charlie. The organization focuses intently on the patient experience and how patient’s lives are impacted by trial participation. The clinical research industry is trending toward patient-centricity, and conversations with PMG’s investigators about what they want to achieve for their patients helps Charlie advocate for that.
From turning a degree in history into a career in clinical research finances, Charlie has demonstrated the importance of the guidance he offered to help sites amplify their success: “Be flexible and fast. In this ever-changing landscape, sites have to be open to considering alternative approaches to start-up, communication and even to the types of studies your site considers taking on.” When a site’s ability to start up and enroll quickly is the sponsor’s primary motivator for site selection, it is easy to understand the value of this piece of advice.
ACRO launches revamped website
It’s here! The Association of Clinical Research Organization (ACRO), has launched a new website. Redesigned in the context of growing membership and innovation in the clinical research industry, the new website is focused on delivering useful information about ACRO’s activities and impacts on the industry.
From the blog with updates about the organization’s work, to a full archive of comments to regulators, the website offers a deeper look at how ACRO is collaborating with diverse stakeholders to advance the clinical trial enterprise.
We encourage everyone to visit the new website, sign up for the free quarterly newsletter, read about ACRO’s work and be in touch.
You can access the new website at www.acrohealth.org.
The Changing Face of Clinical Research
Technology is changing the face of the world as a whole, person by person and industry by industry. The introduction of technology in the clinical research space is making sweeping changes in an industry that has remained relatively unchanged for the last 15 years. While change is often difficult to navigate and acclimate to, it generally leads to improvements in processes, especially when experience and science merge to develop methods for overcoming age-old challenges. To quote William Pollard, “To change is difficult. Not to change is fatal.”
However, one needs only to examine one’s own experience with change to understand that too much change too fast creates chaos. Finding the balance between too much and not enough change is the way to create sustainable growth.
Why Do I Need Technology?
As technology infiltrates most every day activities, today’s consumers have come to expect increased convenience in every aspect of their lives. This, combined with the ever-increasing complexity of trials, has made it increasingly difficult to recruit and retain participants for clinical trials due to the time and effort participation requires, often including numerous visits to a physical research site. The barriers are enhanced for sites that conduct trials requiring work with a population that doesn’t drive or a demographic in remote areas far from a research site.
Technology as a Solution in the Research Industry
As is the case with general medicine, the emergence of telehealth solutions demonstrates how technology can add convenience to participants’ lives by enabling them to connect and converse with their physician without having to travel to and from their office. For some types of visits, patients can obtain a benefit similar to an in-person visit by connecting with their physician on a computer or mobile device. This saves the participant a significant amount of time typically spent commuting to appointments and sitting in waiting rooms.
Telehealth solutions in clinical trials introduce significant benefits to trial sites and sponsors as well. By eliminating or reducing late arrivals, missed appointments, and the transition time between seeing patients, opportunity exists for research sites to increase efficiencies and therefore the number of patients they see each day. This increases productivity and profitability for both the site and sponsor.
A plethora of technology solutions extend beyond telehealth. Electronic data capture (EDC), electronic regulatory binders (eTMF) and electronic source (e-source) have played a significant role in simplifying the collection and exchange of data. Electronic informed consent forms (eICF) provide a means to consent a clinical trial participant remotely on a mobile device or computer, and often includes a video explanation of the study which improves participant understanding of the trial and overall ICF process. The benefits introduced by the adoption of clinical payment solutions are vast within the site community. SCRS VP of global engagement Dan Milam shared, “Whether sponsors and CROs pay sites monthly or quarterly is not just a timing issue. This is an issue of whether or not sites can stay in business.”1 The ability to automate and streamline the management and processing of site payments has dramatically improved study start-up timelines, made delivery of study funds timelier, and increased sites’ ability to sustainably conduct work.
The Dangers of an Extreme Shift
While there are undeniable benefits to incorporating technology for all players in the clinical research space, it is important to consider the potential downfalls of making an extreme shift too quickly, utilizing technology in a manner that decreases connectivity, or simply using the wrong technology.
Click here to continue reading this article in SCRS’ Spring 2019 InSite Journal.
Q&A on Building Stronger Bonds with Investigators to Enhance Site Operations
Meridian Clinical Research has created a unique program to support the success and growth of its investigators. In this Q&A, Wes Bonner, vice president of strategic development at Meridian, shares how Meridian supports its investigators and why that support creates advantages and enhances site operations for the organization.
What makes your role at Meridian unique?
I’m responsible for ensuring Meridian’s investigators are aligned and engaged with our organization and vice versa. My role is a unique position of investigator liaison, business development, and new site vetting and enhancement.
Meridian strives to minimize the administrative burden and overhead for investigators at our dedicated and embedded research sites across North America. To do this successfully requires constant communication with our investigators and, in some cases, existing clinical practice executives and managers.
As Meridian’s investigator liaison, I also function as each investigator’s advocate to the leadership team. This entails routine calls and face-to-face time with each investigator. We want our investigators to have every opportunity to voice ideas so we can address all issues strategically and consistently. From there, we leverage investigator feedback to strengthen the way we support them.
What does Meridian do differently when it comes to engaging investigators?
In the past decade, we’ve focused on providing resources that go well beyond the traditional embedded site model. We provide dedicated staff at each site in-house quality programs, centralized regulatory support, contact center and patient recruitment support, and other forms of training that increase investigator support and decrease liability for practices. This frees up more time for investigators to provide oversight and allows us to optimize working relationships.
One of the keys to sustainable growth has been the thoughtful vetting of sites. New sites are only added when 1) there’s a viable study pipeline for the site and 2) we predict a healthy relationship with the potential investigator(s) and office administrator(s). This careful vetting increases and reinforces consistency, efficiency, and quality in conducting our future research and positions Meridian as a preferred partner with sponsors and CROs.
Does this help investigators become more invested in clinical research?
Absolutely. Beyond improving our organization’s engagement with investigators, we aim to help connect them with the greater research community. We want to help investigators expand their personal networks and connect directly with sponsors and CROs.
Our team regularly attends industry events with our investigators and works to enhance their visibility. I also present or participate in panels at several conferences each year. When doing so, I use the opportunity to talk about investigator relationships and generate ideas for how Meridian can strengthen investigator engagement to improve trial conduct and service delivery. Much of this happens in sessions with representatives from sponsors, CROs and other site networks.
How else has this approach enhanced research conduct at Meridian?
One of Meridian’s top assets is our ability to collaborate among sites. Our sites share best practices, standardize processes, and remotely support one another as needed. Our sites can also accept the same contract language and budgets. My role enables our investigators to have the same level of collaboration and continuity on a peer-to-peer level.
We hold training meetings and attend events so investigators and clinical personnel can meet in person and talk in structured and unstructured environments. Communication has improved companywide as a result, and investigator attendance and interest in these events has grown considerably.
Altogether, this brings investigators closer to their research while breaking down the silos that trigger disengagement. This approach improves the way we engage investigators, recruit and retain patients, communicate with practices, and deliver high-quality research.
Meridian is deeply invested in our investigators’ success. We want them to feel supported and know that we go to great lengths to enable them to provide oversight with confidence.
Founded in 2012, SCRS is a global trade organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, connectivity and mentorship. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community.