If you’re a small to mid-size pharma sponsor currently outsourcing trial management and monitoring to a CRO, chances are it was due to resource constraints. Sponsor organizations often are lacking the necessary resources to successfully purchase, manage and maintain in-house solutions. However, outsourcing as the primary practice can often lead to a dependency on the CRO partner and its technology, including CTMS and RBM systems, or an inability to gather data from all of your CRO partners in a standard manner that allows oversight and cross-study reporting.
With the most recent ICH E6 update and a growing need to standardize and aggregate data from across multiple CRO partners, more and more Sponsors are reevaluating the pros and cons of each paradigm.
This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency. Come join us as we explore the topic through case studies and look at ROI considerations associated with different outsourcing options, helping you decide an approach right for you.
- Industry regulations including the recent ICH E6 changes and how they impact outsourcing decisions
- Key cost considerations when evaluating buy vs outsourcing
- Efficiencies gained through purchase and ownership of in house CTMS and RBM platforms
- Is there another paradigm to consider?
Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica
Kristin Mauri, MBA, PMP, heads Bioclinica’s global risk-based monitoring (RBM) practice and maintains responsibility for the technology and services practices. Ms. Mauri brings to Bioclinica more than 20 years of clinical operations experience and eClinical technology implementation for pharma, biotech and CRO organizations. Prior to joining Bioclinica, Ms. Mauri was Director, Product Strategy at Oracle Health Sciences where she was responsible for growing both the technology partnership program, as well as leading the risk-based monitoring strategy. A recognized thought leader and industry speaker, Ms. Mauri has presented broadly on clinical operations topics within the realm of emerging eClinical technology. Ms. Mauri’s educational credentials include an MBA from Lake Forrest Graduate School of Management, MGH Boston master’s program coursework in Clinical Investigations, and a bachelor’s degree from Pennsylvania State University.
Justin Hunt, Director, CTMS Implementation Services, Bioclinica, Inc.
Justin Hunt is Director, CTMS Implementation Services at Bioclinica. He is responsible for the CTMS product at Bioclinica and leads the teams that implement OnPoint for Bioclinica customers and provide the post-implementation support. Prior to Bioclinica, Justin was Director of Operations & QA for TranSenda, which was acquired by Bioclinica in 2010, and has worked with the OnPoint product since its launch in 2005. He is based in Bellevue, WA, USA.
Who Should Attend?
C-level and senior professionals responsible for clinical trials, including:
- Clinical Operations
- Clinical Outsourcing
- Project Management
- Strategic Planning
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.