Risk-based monitoring (RBM) has become a clear imperative for the life sciences industry because of its compelling value proposition. Both FDA and EMA have provided strong endorsements for RBM, and industry groups including TransCelerate have provided additional guidance and support. Despite this, many organizations are struggling to move forward effectively. Several key factors have conspired against RBM progress. These include natural resistance to change – often supported by misperceptions about increased quality and regulatory risk – and a level of RBM over-engineering that results in complex, burdensome implementations especially during already pressure-packed study planning and set-up periods.

But the reality is that RBM does NOT need to be complicated or burdensome to your organization. Industry and RBM experts Andy Lawton (Boehringer-Ingelheim) and Steve Young (OmniComm Systems) will share their insights on RBM keys to success. The following topics will be covered:

The Growing Evidence in Favor of Risk-Based Monitoring
RBM Over-Engineering – Sifting through All of the Advice
Review the Keys to RBM Success

Keywords:

Speakers

Steve Young, Senior Director of Transformation Services, OmniComm Systems, Inc.

Steve Young brings more than 20 years of clinical research experience to his role as Senior Director of Transformation Services at OmniComm Systems. Prior to joining OmniComm, Steve led the development of Medidata’s Insights and site monitoring solution portfolios, and provided risk-based monitoring consultation to numerous customers. He led a pivotal SDV analysis in collaboration with TransCelerate and co-authored an article with them in DIA journal presenting the results. Steve previously spent a number of years in clinical data management leadership positions, where he successfully led the enterprise roll-out of EDC at both J&J and Centocor.

Message Presenter

Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim

Andy Lawton has extensive experience in Computing, Statistics, Data Management, RDE/RDC, System Design, RBA in CSV and Clinical trials. He has previously worked with Seismic Exploration (1971-1972) and National Health Service (NHS) – Consultant Statistician (1979-1984) and is currently at Boehringer Ingelheim (1984 – present). He became the Global Head of Clinical Data Management on 1st Jan 2013. This is a new strategic role within BI responsible for SOPs, Governance of processes/systems and new initiatives in the CDM area.

Beyond that, Andy is a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publication is the paper with Dr. Alistair Ross on GP Audit – throughout 80’s and 90’s this was the most quoted paper in the BMJ.

Message Presenter

Who Should Attend?

Heads of Clinical Data Management
Heads of Phase I Clinics
Heads of Operations
Heads of Clinic Systems
Heads of Clinical Pharmacology

Xtalks Partner

OmniComm Systems

OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s Pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.