More than a Four-Letter word, Risk is an Opportunity
Uncover and seize the opportunities to expedite studies
Risk management is central to avoiding the dreaded rescue study, cost overruns, delays in regulatory filing, market entry, and above all else the delivery of new therapies to patients. Risk management in study startup, a notorious bottleneck in the conduct of clinical trials, entails the proper identification of red flags that signal the study is veering off course. Risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace.
Most people don't like talking about risk. We've all been conditioned to think of risks as negative. Sometimes risk is really an opportunity. Not all risks are there to be avoided. Positive risks or opportunities are uncertain, but favorable events if they occur can positively impact study objectives, saving costs and reducing timelines.
But how can these potential risks be identified? And what strategies should organizations use for positive risks?
In this webinar, we will explore:
- The importance of risk management for the identification and tracking of both negative and positive risks.
- How to manage positive risks effectively and associated strategies: exploit, share, enhance and accept
- The importance of automating document workflows (e.g., alerts, ensuring compliance, role-based assignments, etc.)
- The need for standards and performance metrics for benchmarking and projections
- The importance of improving collaborations with transparent communications
This webinar is applicable to:
- Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating trial metrics
- Sponsor and CRO roles responsible for project management of studies
Lorena has more than 20 years of experience in clinical development, having started her career as a phase I coordinator in 1996. She has gone on to hold leadership roles in both Clinical Operations and Project/Program Management and is currently the Global Director of Strategic Start Up and Essential Documents at Allergan. Prior to starting with Allergan in 2016, Lorena oversaw Start Up Strategy and Clinical Outcomes Assessment Management across all therapeutic areas at AbbVie.
Lorena holds a BS in Microbiology, a BA in Molecular Biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program. In 2011, she was awarded the PharmaTimes Clinical Researcher of the Year silver medal in the Project Management Category. She has been a core team member for the TransCelerate Shared Investigator Platform and Investigator Registry Initiatives since 2013.
LORENA R. GOMEZ
Director, Global Study Start Up & Essential Documents
Joan provides marketing and strategic planning, guidance, and direction to companies and professionals to further build their presence in the clinical trials enterprise. Ability to lead, motivate, mentor and establish trust and loyalty at all levels internally and externally.
A well-known speaker at industry conferences, Joan has presented on a wide variety of topics specific to the clinical trials enterprise. In the course of her career, she has also published in clinical trade journals. For five years, she was an instructor for Barnett International's CRA/CRC programs on the site identification/qualification process. Joan is on the Board of Directors for Greater Gift, The Center for Information and Study on Clinical Research Participation (CISCRP), the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/Informa Clinical & Research Excellence Awards, Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA).
Joan's 20+ years in the health life sciences industry includes eight months with SCORR Marketing as a Senior Strategic Advisor; over seven and a half years with CenterWatch as COO; two and a half years with Cambridge Healthtech Institute as Senior Director of Marketing & Operations-Publications; two and half years with the Tufts Center for the Study of Drug Development at Tufts University as Director of Strategic Marketing & Development; seven and a half years with Thomson CenterWatch as Senior Director of Marketing & Sales; and four years working for PAREXEL International as Site Selection Specialist. Joan holds a B.S. in Marketing.
JOAN A. CHAMBERS
Independent Marketing & Strategic Advisor
Ed has over 25 years' experience in the life-sciences and healthcare industries, building and leading teams in clinical operations as well as portfolio and partnership management. He has extensive experience in global management across regions and countries.
Prior to joining TFS Ed was the Sr. Director & Global Delivery Head, Customer Operations at Quintiles, and his career includes clinical management positions at PPD, Novartis, Sanofi-Sythelabo, AstraZeneca, and Alcon. Ed holds a Bachelor of Science (BS) degree in Biology from Villanova University.
VP Clinical Development
Andrea has over 20 years of product management experience, most recently serving as VP of Product Management for RelayHealth where she was responsible for product strategy, research, and strategic initiatives around Health Information Exchange and Clinical Integration. Her career has also included product management roles at Healtheon/WebMD, Quovadx, and Oracle Corporation. Andrea holds a Bachelor of Arts degree in Molecular Cell Biology from UC Berkeley.
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