Over the last decade, the drug development industry has realized the benefits of monitoring trial conduct, safety, data integrity, compliance and enrollment through improving risk-based monitoring (RBM) methods. As a result, we are seeing several recommended changes in our approach to research.
In fact, the US Food and Drug Administration (FDA) has released guidance regarding the adoption of new RBM strategies to support safer, more efficient and higher quality clinical research. Scott Gottlieb, the former commissioner of the FDA, has been a longtime supporter of RBM and in a recent statement he explained:
“The FDA isn’t alone. The advent of precision medicine is challenging the entire medical research ecosystem to develop more efficient approaches to testing and developing diagnostics and therapeutics… including frameworks that are more carefully suited to the kinds of precision technologies that underpin new treatments.”
But, for various reasons — including the potential for change to jeopardize approvals — drug sponsors have been slow to adopt these innovative research methods, and the lag is costing the pharmaceutical industry huge amounts of both time and money.
In this free webinar, the featured speaker will discuss how adopting a comprehensive RBM strategy supported by today’s newest data integration and management technologies — including direct data capture (DDC) systems — are making new efficiencies possible across the development spectrum.
Jonathan Andrus, Chief Business Officer, Clinical Ink
Jonathan Andrus has more than two decades of experience developing eClinical solutions that integrate data and technology to help life science companies optimize study execution. As chief business officer at Clinical Ink, he is focused on helping study sponsors and clinical research organizations (CROs) better leverage eSource, eCOA and ePRO data for use throughout their trials. Johnathan has spent his career in leadership positions at eClinical service and technology organizations, supporting industry associations like SCDM, CDISC, DIA and ASQ. Thanks to his vast industry experience, he is also an active thought leader, blogger and presenter. At Clinical Ink, Johnathan also works on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals across the industry.Message Presenter
Who Should Attend?
This webinar will be suitable for executives, scientists, directors and managers from pharma, biotech and CROs working in drug development, including:
- Strategic drug development
- Head of therapeutic areas
- Clinical operations
- Clinical science
- Outcomes research
- Data management
- Outsourcing and procurement
- Clinical trial planning and optimization
What You Will Learn
Attendees will learn about:
- The advantages of using eSource systems, including ePRO and eCOA, for capturing data directly from the patient
- The impact of time and cost savings associated with DDC including reducing site monitoring visit frequency and eliminating source document verification and review
- The power of on-demand data and a complete audit trail in study planning, decision-making and regulatory submission
Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our eSource clinical technology and configurable ePRO and eCOA modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Accelerate the completion of key clinical development milestones in your study and confidently manage your trial’s critical decisions with our flexible menu of collaborative services, remote monitoring support, and a complete, real-time view of your trial.