What will the future of clinical research hold? What PROCESSES will we keep and what PEOPLE AND TECHNOLOGIES will we need to have moving forward? Join our panel as they provide their insight into what the future may hold and how they suggest you should prepare.

We will be discussing the challenges we experience in conducting multi-country clinical research, including how differences in policies, regulations, as well as language barriers may affect our study planning and execution.We encourage all our peers to participate, including CRAs, project managers, investigators, and site coordinators, regardless of their experience in multi-country clinical research.We believe the clinical research industry is trying to introduce new medicines and devices to benefit patients globally, especially in developing countries where people may otherwise not have access to healthcare. Also, there is increasing awareness that diversity among clinical trial participants is vital to better evaluate the safety and efficacy of medical products.Therefore, we want to share with the audience our experience in global clinical research, as well as risk mitigation tools that can help in the conduct of multi-country clinical research.

In this session, two key opinion and thought leaders from the clinical research industry will discuss their very distinctive, yet successful career pathways. Careers in clinical research do not sit solely into two baskets, the Clinical Research Coordinator (CRC) or the Clinical Research Associate (CRA). As the clinical research industry continues to evolve, so does the work needed to support these new methods. The skills gained in and throughout varied positions, help pave one’s career pathway. The ability to leverage those experiences and parlay them into the next opportunity is key. Multiple business functions provide exposure to processes throughout the clinical research enterprise and enable a diversified set of skills. Each steppingstone, though it may not seem like a direct route, provides the building blocks for success. Clinical research professionals by design, pay attention to details, follow the rules, and have a common goal to improve health. Identifying steps for navigating career silos and assessing opportunities are proven tools for career growth. Presenters will provide insights on how clinical research professionals can leverage their experience and expertise to impact their careers. Analyzing lessons learned, tips for career development and case studies will be addressed in this session.

The COVID-19 pandemic put a floodlight on weaknesses and gaps in clinical research workflows, policies, and work structures. In some hospitals and academic medical facilities, it halted research operations altogether. In a field where time is of the essence, clinical research professionals must establish contingency plans for the conduct of research during pandemics and other unforeseeable catastrophic events. Contingency plans need to be comprehensive and able to represent the diversity of research designs and medical specialties of your institution. They must also address how and when non-crisis workflows (i.e., SOPs, team roles, ancillary services), policies (i.e., ethical regulations, institutional requirements, etc.), and work structures (remote, hybrid, in-person) should adapt to crisis mode operations. Most importantly though, the plans must also outline how and when to return to non-crisis operations. This expert panel of clinical research leaders for the Department of Surgery at the Medical College of Wisconsin will outline how they adapted the Department's research conduct at the height of the pandemic while remaining in compliance with federal and institutional requirements. They will also speak on how they took a stepwise approach to safely return to non-crisis operations. The panel will conclude with a discussion on lessons learned - what elements worked, what they would do differently next time, and is it possible to have a one-size-fits-all crisis contingency plan?

We will describe our Center’s use of an electronic research delivery platform to expand participant adherence to two longitudinal clinical trials utilizing wearable technology. We will share our development of workflows to use the electronic platform and effective data management strategies to ensure participant safety, protocol compliance, study completion, and data integrity. By creating automatic pathways to guide a participant through the trial, our team was able to ensure quality trial delivery involving less manual work and human error, while maintaining regulatory rigor and research integrity. Our framework serves as a model in conducting completely virtual research. Each trial utilized wearable technology to passively collect data from participants, and successfully utilized the electronic platform as a basis for participant communication and trial conduct. Workflows were created which guided participants through enrollment, informed consent, and study interventions with limited hands-on work by the study team. By automating these processes, we were able to increase participant engagement without jeopardizing participant experience. Through this, we managed participant adherence to trials involving myriad study requirements over many-week periods, reducing the likelihood of participant dropout in trials which would otherwise run a risk of experiencing such. The techniques detailed in this session will equip audience members with the knowledge needed to implement similar strategies for observational or interventional clinical trials, benefitting their study teams and, most importantly, participants. Any clinical trial which engages a large participant population, has a long-term time frame, or requires participant adherence to multiple protocol requirements can benefit from our experience.

This session will contribute to the core competency of Communication and Teamwork. Communication is critical for the success of any research study and has become increasingly challenging as a result of the pandemic and higher prevalence of remote work. Following this session, attendees should be able to demonstrate the ability to coordinate and manage communicate with their internal teams and with stakeholders (ie Sponsor, IRB, etc).

Study and Site Management presents many challenges over the course of the research study. Regardless of the size of the research site or whether you are leading a multi-site study or a participating site within a study, you may often feel you are swimming against a current of issues including communication barriers, an ever changing research environment, and frequent coordinator turnover. This panel discussion will review impacts of coordinator turnover from a site and study level, methods for maximizing study productivity and communication in a virtual world, and strategies for adapting to changes in the research environment. Attendees will gain practical tips and information for minimizing impact of coordinator turnover and building robust research teams that are both adaptable and effective in today’s research world. Attendees will also have an opportunity to engage in Q&A with the presenters and audience to discuss and strategize site specific issues related to study and site management.

The purpose of this presentation is to introduce an Electronic Signature System (ESA) as a fast, efficient, and trustable mean of communication among research professionals. Nowadays, ESAs is a fascinating hot topic in research that can assist with the management of the high volume of documents that clinical researchers handle every day. This presentation will introduce to the audience a research study conducted in an Academic Institute. This study demonstrates how the use of ESA supports clinical research professionals by facilitating PI oversight. Thus enhancing patients safety and increasing productivity of the researchers. In addition, ESA facilitates regulation compliance and permits a higher level of accuracy in clinical trials. The audience will learn why using ESA can facilitate and improve the management of their studies. They will learn how to use it efficiently and will receive advices and specific details about this new technology.