Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
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Clinical trials are increasingly complicated with more data sources than ever. As decentralized trial models, systems and approaches become more common, handling data from these systems in addition to EDC, IVR, eCOA, Labs and Specialty labs adds even more diversity to clinical data sets. CROs experience this challenge tenfold as they work with numerous sponsors, all of whom may have preferred providers, making the process of standardizing and reviewing data from numerous sources across trials even more challenging. The elluminate® Clinical Data Cloud is the foundation of digital trials and provides one centralized source of truth across all sources speeding collaboration across clinical teams, time to insight and speeding cycle time metrics like Last-Patient-Last-Visit to Database Lock.
This webinar will discuss how many life science companies and CROs are still relying on manual methods including excel spreadsheets and SAS programs to ingest, standardize and integrate data for review and the challenges associated with these approaches. The capabilities of a platform like elluminate will be discussed, including automation across the data lifecycle from ingestion through submission, and how a clinical data platform can be implemented into an existing CRO infrastructure.
This webinar is designed for CRO team members in these functions:
- Data Management
- Clinical programming
- Analytics
- Data Sciences
- Medical Monitoring
- IT
Presenters
President and Co-Founder, eClinical Solutions
With over 20 years of experience in the medical and life science industries, Bob has built organizational strategies and processes for a myriad of organizations responsible for the collection of data including ePRO, Lab, IVR, and clinical data. As one of the founders of eClinical Solutions, he designs and implements strategies for the industry adoption of the technologies and services offered by the organization, as well as identifying and building strategic partner channels for business development. Bob’s unique interpersonal skills and drive in building positive company culture enables him to pursue his true passion, which is coaching, mentoring, and helping employees reach their personal and business objectives.
Vice President, Business Development Operations, eClinical Solutions
Dawn has over 20 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.
