PurpleLab Enhances Clinical Trials with Managed Services Solutions

Clinical trials are essential for evaluating the safety and efficacy of new medical therapies and devices. They gather vital evidence to determine if a product is safe for patients and effective at the intended dosage. Recently, advancements in statistical techniques and technology have improved the accuracy of clinical trial results. However, these advancements have also introduced complexity, highlighting the need for thorough pre-trial planning.

To navigate these challenges, life sciences companies must have a clear strategic direction for the assets they are developing. This involves understanding market size, dynamics, and the clinical economics of the health conditions they aim to treat. Specific questions must be addressed to inform trial design and anticipate how a new asset might influence existing market conditions.

PurpleLab Managed Services offers solutions to these industry-wide challenges by empowering clinical development teams to optimize trial execution and minimize risks through the use of comprehensive real-world data. In an interview with Jason Gagner, VP of Product Management at PurpleLab, he emphasized the importance of anticipating potential hurdles throughout the asset lifecycle, from early trials to post-launch evaluations.

Strategic Planning and Execution

Gagner notes that successful clinical teams create detailed action plans and establish key performance indicators (KPIs) early in the project. “The Managed Services team at PurpleLab, supported by robust data, ensures seamless transitions between trial phases and project milestones,” he stated. This approach reduces the need to start each phase from scratch, allowing teams to build on the insights gained from previous stages.

PurpleLab’s Managed Services play a critical role in enabling clinical teams to respond effectively to market trends and shifts. Gagner explained, “Even before you start your phase 1, we can monitor the clinical space and identify significant market concerns that might impede new therapies.” This proactive monitoring acts as a risk mitigator, allowing companies to adjust their strategies in response to evolving market conditions.

In one illustrative case during a haematologic disease trial, PurpleLab successfully identified 15 high-performing sites that achieved an impressive 80% enrollment success rate, significantly reducing startup time. Furthermore, an analysis of PET scan utilization revealed a year-over-year increase in the technology’s usage, even as the proportion of patients receiving PET scans within specific diagnostic subgroups decreased.

Regulatory Insights and Market Strategies

Regulatory bodies, particularly the Centers for Medicare & Medicaid Services (CMS), play a pivotal role in drug classification and reimbursement processes. Gagner highlighted that PurpleLab actively monitors federal policy changes and engages with Requests for Information (RFIs) and Requests for Comment (RFC) issued by agencies such as the FDA.

He noted that the FDA’s recent RFC focused on the use of HL7 Fast Health Interoperability Resources (FHIR) for real-world data submissions. “This could bridge the gap between data collected in clinical practice and data submitted as part of a study,” Gagner explained, emphasizing how this integration could inform future therapy development opportunities.

PurpleLab also addresses issues related to drug classification, helping companies navigate the complexities of reimbursement. “There’s specificity that’s lost in some medications, drastically changing reimbursement for those treatments,” Gagner stated. By providing evidence to CMS, PurpleLab aids in ensuring that healthcare systems receive appropriate reimbursement for their services.

The company’s approach also involves classifying and standardizing terminologies relevant to patient populations. This includes using coding systems such as NDC codes for patients on GLP-1 medications and ICD10CM codes for cystic fibrosis diagnoses. By mapping these terminologies across various standards, PurpleLab ensures consistency in communication and evaluation.

Gagner emphasized the importance of PurpleLab’s HealthNexus platform, which addresses industry pain points related to vocabulary acquisition and maintenance. “Without this solution, life sciences companies struggle to create and maintain value sets,” he explained. By offering clinical informatics expertise tailored to both clinical and commercial objectives, PurpleLab supports clients in managing project costs, timelines, and milestones effectively.

With over 25 years of experience in healthcare, Gagner has held various leadership roles and received accolades for his contributions to healthcare informatics. He holds an MBA from Vanderbilt University and an MS in Biomedical Informatics from the University of Utah School of Medicine. Under his guidance, PurpleLab is positioned to drive innovation and efficiency in clinical trial development, ultimately improving patient outcomes and expediting the introduction of new therapies to the market.

PurpleLab’s mission is clear: to unify healthcare communication and enhance outcomes. Their comprehensive Managed Services and analytics platform serve as critical tools in addressing the evolving landscape of clinical trials, ensuring that life sciences companies can navigate complexities with confidence and precision.