Risk Based Monitoring: What Works? What Doesn’t Work?
On June 27th, 2017, Collaborations in Clinical Research hosted its first event at HP headquarters in Palo Alto, CA, on the topic Risk Based Monitoring: What works? What doesn’t work?
The recently released E6 R2 Good Clinical Practice guidelines have further defined the use of risk based monitoring and centralized monitoring. This means that sponsors are encouraged to develop an overall strategy for reviewing data, including their on-site monitoring activities. Sponsors are using key risk indicator metrics, remote monitoring, and targeted source data verification to support risk based monitoring.
Collaborations in Clinical Research is hosting a panel discussion on Risk Based Monitoring: What works? What does not work? Panelists will include clinical project managers, clinical research associates, clinical data managers, site research coordinators and software providers. During this session, we will discuss:
- Defining key risk indicators
- Monitoring approaches
- Technologies or tools used
- Overall management of RBM
- Roles and responsibilities
Candace Elek, M.S. / President, ClinPros
Candace Elek is the founder of ClinPros, a management consulting firm supporting clinical development for medical device, pharmaceutical and biotech companies. Candace has dedicated her 15-year career to clinical research in academia and industry. Candace specializes in strategic project planning, execution of clinical trials, and clinical trial cost management. Prior to consulting, Candace spent 8 years at Abbott Vascular, serving most recently as Director of Clinical Research with responsibility for worldwide Clinical Program Management and Clinical Portfolio Management (Financials). Candace earned a bachelor’s degree in Human Development from the University of California-Davis and a master’s degree in Medical Product Development Management from San Jose State University.
Jim Hart, RN, CCRA / Chief Executive Officer, Hart Clinical Consultants
As the Owner and Chief Executive Officer of Hart Clinical Consultants (HCC), Jim Hart partners with medical device, pharmalogical and biomedical pioneers to conduct clinical trial operations that bring technology and innovation to the market. His areas of expertise include cardiovascular, endovascular, neurovascular, pulmonary and diabetes medicine. Hart formed HCC due to a need in the marketplace to supply highly skilled technical advisors to provide a liaison role between clinical trial sponsor organizations and medical and hospital support staff at clinical trial sites. HCC specializes in executing clinical trial plans and training medical and clinical site support personnel on the proper prep, set-up and use of medical devices in a variety of clinical settings, ensuring established indications for use and protocols are expertly followed.
Prior to launching HCC, Hart spent more than 18 years in a variety of roles with Guidant Corporation/Abbott Vascular, progressing to directing U.S. clinical trial operations. Prior to his positions at Guidant Corporation/Abbott Vascular, Hart managed a high-volume endovascular/cardiac cath lab in Orlando, Florida, where he honed his interventional technical skills. Hart maintains active licensure as a registered nurse in Florida and Vermont and has a Bachelor of Science degree in Nursing from the University of Central Florida. He is credentialed as a CCRA through the Association of Clinical Research Professionals.
Lorne Cheeseman / Chief Executive Officer, Kestrel Biologic Inc.
Through his extensive background in managing and training clinical teams, monitoring clinical trial sites, developing SOPs and quality systems, and international clinical research expertise, Lorne knows the clinical industry. He has held national and international leadership positions in companies such as Pfizer, Quintiles, Gilead Pharmaceuticals and Allergan that provided a solid base for his role at Kestrel Biologic. Lorne took on the role as CEO at Kestrel Biologic in 2013. He has taken the company to the next level and is determined to make iQROS™ a household name in the pharmaceutical industry.
Moderated by Carey Smoak / Senior Consultant, Clinical SAS Programmer Analyst, DataCeutics
Carey is a co-founder and co-leader of the CDISC Medical Device team. Carey has 34 years of experience with using SAS software. His first 15 years, he worked in academia. For the past 19 years, he has worked for medical device (11 years) and pharma / biotech (8 years) companies. He has been involved in more than 20 products that have been cleared / approved by the FDA. He has more than 40 publications to his credit and is a frequent speaker at conferences and meetings. His areas of expertise include in-vitro diagnostic devices, companion diagnostics, vaccines, thrombosis drugs, oncology drugs and other therapeutic areas. Carey currently works for DataCeutics as a Senior Consultant in statistical programming.