Today, study teams and sites rely on a collection of siloed point solutions that weren’t built to work together, creating redundancy and inefficiency. This unsustainable environment produces inconsistent, missing or duplicated data; issues that are exacerbated by increased volume and variety of clinical data available.
Study teams need more accurate patient information, quickly, to help evaluate the safety, efficacy, and benefit of a drug, device, or therapy, while sites need a more streamlined process to eliminate multiple system logins, credentials, training, interfaces, validations, and more. Clinical research systems need to evolve in order to unify people, processes, and data to simplify and accelerate clinical trials.
We’re joined by Lindsay Reklis, Associate Director, Data Solutions and Analytics for FHI Clinical, for an inside perspective regarding proper planning and implementation of process workflows and unified technology platforms to allow study teams to manage better quality data, more efficiently, and gain critical insights in support of clinical development programs.
About the Presenters
Associate Director, Data Solutions and Analytics, FHI Clinical
Lindsay is a clinical research professional with over 16 years experience in biotechnology, with demonstrated expertise in clinical project management, clinical operations, data management and vendor management for small- to mid-sized pharmas and large CROs. At FHI Clinical, she coordinates with cross-
Sales Director, Emerging Biopharma, Oracle Health Sciences
Michael has 18+ years experience working in the pharmaceutical services industry in Europe and North America, having worked in the CRO / outsourcing, clinical supplies and eClinical technology fields. For the last 5 years with Oracle Health Sciences, Michael has been focused on supporting Emerging Biopharma companies to adopt and utilize eClinical technology, helping customers to reduce clinical trial timelines and costs.