7:15 am Sponsored Breakfast (Opportunity Available, Contact Arnie Wolfson: 781-972-5431, awolfson@healthtech.com ) or Breakfast on Your Own
8:00 Creating a Collaborative Environment at Monitoring Visits: A Global Perspective
Carol Opalek, Clinical Research Associate, Abbott Vascular
In 2008, a survey was developed comparing and contrasting CRA and CRC perceptions of qualities of an interim monitoring visit. In a follow-up to that survey, the same instrument was administered to a primarily South African population of coordinators and monitors in 2009. Respondents to this follow-up survey were from Kenya, India, and Australia. This session will explore both the remarkable similarities and the differences in the responses, and the possible cultural implications of the answers given. Discussions will focus on the subjective responses given, and the importance of professionalism, visit preparation, and follow-up after a monitoring visit. Key take away messages include the importance of communication and time management skills. The roles of CRCs and CRAs are truly global in nature. Just like Good Clinical Practice principles, the harmonization of roles and expectations at visits must be practiced no matter where the visits take place. This survey is a small step in understanding perceptions from both sites and sponsors point of view and working collaboratively in this endeavor.
8:40 Global Monitoring: Strategies for Managing Sites in both Developed and Developing Regions
Rodrigo Crispim, Site Monitoring Manager, Brazil Regional Clinical Operations, Bristol-Myers Squibb
Globalization is a reality for conducting clinical trials, and with that comes the need to understand how the regulatory climate and the overall level of clinical trial experience of each country effects the monitoring responsibilities required. Additionally, the understanding of the relationships and expectations that the medical community has of the pharmaceutical industry can be different for developed versus developing regions. Given that clinical trials around the globe can bring opportunities, like more efficient subject recruitment as well as potential financial savings, how to ensure patient safety and consistent data quality throughout all regions is a key monitoring deliverable.
9:20 Monitoring Informed Consent in India: Addressing Ethical, Regulatory, Sponsor, Protocol, and IRB Requirements
Rao Teki, M.D., Vice President, Clinical Operations, MakroCare
As India is becoming a global hub for clinical research and services, there is a current need for good understanding of local regulations and ethics. This presentation covers the required information, including how to work with India and its service providers with local guidelines; GCP and Drug Controller General of India (DCGI); and local regulatory agency’s guidelines on ICF. Clinical research activities are shared among multiple players like sponsor, investigator, IRB, and monitor. Each player needs to be aware of their specific responsibilities, and most importantly, how the socioeconomic, cultural, and literacy of study subject plays a role in executing ICF.
10:00 Networking Refreshment Break and Exhibit Viewing
10:20 How to Go from Being a Good CRO Monitor to a GREAT CRO Monitor
Brenda Reese, Executive Director, West Coast Operations, Clinical Operations, DSP Clinical Research
Research has shown based on the current economic situation, pharmaceutical companies are going to continue to downsize, restructure, and increase their outsourcing of clinical trials to CROs. This increased outsourcing will result in a need for monitors who understand the CRO model, the preconceived opinions of a CRO monitor, site conceptions of a CRO monitor, and the job expectations of a CRO monitor. The success of a CRO truly lies within the monitoring team. This presentation will focus on providing guidance, practical tips, and demonstrate through case studies how one can truly be a GREAT CRO monitor and, in turn, be a part of a great CRO. In her roles at large pharmaceutical companies, small biotechnology companies, and both large and small CROs, this session’s speaker has extensive experience improving site and monitor relationships. Sponsors, CROs, and monitors alike will gain insight into becoming and appreciating the GREAT CRO monitor.
11:00 Whose Job Is It Anyway? Sponsor Strategy for Ensuring Quality and Integrity in Clinical Trials while Enhancing CRO-Site-Sponsor Relationships
Rebecca Darlington, Manager, Clinical Operations, Otsuka Pharmaceutical Development & Commercialization
Sponsors face unique challenges when clinical trial monitoring is outsourced to a third party. This session will explore the importance of sponsor oversight of outsourced monitoring activities. We will look at Otsuka’s successful “Accompanied Visit Program,” a program which provides oversight of clinical trials globally when the monitoring function is outsourced. Your speaker will share the details of the program, as well as real-world applications of lessons learned from this initiative. Monitors will gain a deeper understanding of the rationale for sponsor oversight and how this responsibility can further develop the CRO-Site-Sponsor relationship.
11:40 Best Practices for the CRO Monitor: Managing Various Scenarios, Establishing Clear Communication, Developing SOPs, and Managing Staff Turnover
Amal Kumar, Team Lead-Research Scientist, Clinical Research and Pharmacology, Cadila Pharmaceuticals Limited
Best practices for the CRO monitor are required throughout the entire clinical research area. In the global environment, there are many hidden practices that can help us manage the quality, cost, and timeliness of research and decision-making. Complete management of clinical trial process involves patient management, clinical data management, and clinical trial staff management. Given the complexities that exist in clinical trials, it has been difficult to measure the efficiency and effectiveness of the trial process quantitatively. The best practice by sponsors assures that clinical investigators abide by their obligations for the proper conduct of clinical trials. This session will present different scenarios and variations of results in multi-centric trials. The audience will learn the benefits of employing best practices of clinical research findings in operational and decisional research, the key factor in research success and failure.
12:05 pm Sponsored Luncheon (Opportunity Available, Contact Arnie Wolfson: 781-972-5431, awolfson@healthtech.com ) or Lunch on Your Own
1:35 Sponsor and Site Communication: Principles for Developing an Effective and Rewarding Site-Sponsor Partnership
Deborah Lasher, RN, MPH, CCRC, CCRA, Senior Clinical Research Specialist, Diabetes Clinical Research, Medtronic, Inc.
Site management of clinical trials is both an art and a science. The regulations and processes of the clinical research enterprise are more concrete and overt than the subtle nuances of effective communication between the site and sponsor as partners in a clinical trial. Individuals have varying degrees of inherent communication skills. Most monitoring professionals are hungry for new perspectives on what makes communication effective and how we can influence others by the messages we send. Effective, positive, and productive communication skills are a critical component of a “Master” Clinical Trial Monitor. In fact, in the U.S., it has been noted that “communication skills” have recently surpassed “technical skills” as the most important quality when hiring professionals. This presentation will provide communication principles for any clinical research professional with specific examples tailored for monitors in preparing for site visits and when communicating critical information with study partners.
2:15 Improving the Monitor’s Reputation: “Fixing” Site Misperceptions of the Monitor’s Role
Amy Adams, Clinical Project Manager, Regulatory Compliance and Human Subjects Protection Program (RCHSPP), SAIC-Frederick, Inc.
This presentation will include ideas and information for monitors on how to improve their reputation with their sites, as well as how to remove the authoritarian stigma that sites often perceive. The speaker will focus on ways to approach sites in a more collaborative manner to create a better working team environment for the sites and the sponsor. Currently, in RCHSPP/SAIC-Frederick, Inc., we begin collaborating with our sites very early in the clinical research process; hence we establish a positive working relationship that ensures data quality and encourages mutual respect. Our foundation, as a program, has been to promote team work with our sites, work with them to overcome challenges, and provide a support system for them when needed.
2:55 Monitors are from Mars, Sites are from Venus: Establishing Successful and Collaborative Site Relations
Harry Barnett, J.D., Managing Partner, Clinical Assistance Programs
There is a marked disconnect when it comes to clinical monitors effectively communicating and working with investigative sites for clinical studies. Although a monitor’s success depends upon his/her ability to establish a productive and positive relationship with the site investigator and study coordinator, the regulatory focus of traditional CRA training is insufficient to serve as a basis for effective site relations. This presentation will emphasize the importance of indication and endpoint-specific knowledge as a precursor to developing a better working relationship with key site personnel.
3:35 Networking Refreshment Break and Exhibit Viewing
3:55 EDC Training Requirements in Clinical Trials: A Monitor’s Role in EDC, CRA, and Site Activities
Tina Pagos, EDC Technology Project Leader, EDC Solutions,
Chiltern International
Effective EDC training is crucial for an EDC trial to be successful. A monitor’s role within EDC encompasses not only onsite and in-house review of data, but also acting as a site’s resource for EDC data entry/query resolution. A clinical trial is only as successful as the quality of data entered. It is crucial for CRAs to understand both study team and site activities within EDC to increase data quality, and cut down on the time from last patient in (LPI) to database lock.
4:35 Electronic Medical Records: Overcoming the Obstacles in Monitoring the EMR
Dana Haudek, Manager, Clinical Operations, Research/Vascular, Abbott Vascular
This is a discussion about how a monitor can overcome the many obstacles of monitoring the electronic medical record. Beginning with managing the sponsor’s expectations and responsibilities in site selection, this session will cover how to manage time with the site’s research coordinator, communicate difficulties with the site to the sponsor, gain access to the EMR, and ultimately verify copies of the medical record. The speaker will share her monitoring group’s experience with difficult processes at sites in getting access to the EMR. Best practices will be shared, including questions to be asked during site assessment, and statements that may be added to a site selection standard operating procedure for accessing and monitoring the EMR.
5:15 Close of Conference