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Beyond Protocol-Specific RTSM: How to Optimize Clinical Operations at Portfolio Scale

If you're managing multiple clinical trials, you're likely facing a familiar paradox: while RTSM systems have become more sophisticated, your operational complexity keeps growing.

Sites juggle dozens of usernames and passwords. Study teams recreate the same processes for every protocol. IT groups spend weeks setting up data feeds, study by study. 

The problem isn't your RTSM technology; it's that protocol-specific thinking is creating operational silos that prevent you from working efficiently at scale. 

Why Traditional RTSM Implementation Creates Operational Bottlenecks 

The Protocol-Centric Problem 

Most organizations approach RTSM with a protocol-first mindset. Each study gets its own implementation, leading to: 

  • Site frustration: Multiple credentials to manage across studies, creating the #1 pain point sites report
  • Study team inefficiency: Substantial time spent on administrative tasks that should be standardized
  • IT bottlenecks: Manual setup of monthly data transfers for every protocol
  • Lost portfolio visibility: No way to see operations across your entire research program 

The Real Question You Should Be Asking 

It's not whether your RTSM can handle your randomization needs—most modern systems can. The critical question is: How can you break down the silos preventing you from operating efficiently at portfolio scale? 

Transforming from Protocol-Specific to Portfolio-Level Clinical Operations

What Portfolio Optimization Means for Your Organization 

Instead of treating every protocol as an isolated implementation, portfolio-level optimization identifies what doesn't need to be protocol-specific and standardizes it across your entire research program. This fundamental shift affects three critical operational areas: 

  1. Unified Identity Management: Eliminate Credential Chaos

The Challenge: Sites managing separate logins for every study across multiple solutions create workflow interruptions and security risks. 

The Solution: Signant's SmartSignals ID Portal provides every user with a single identity across all solutions—RTSM, eCOA, and eConsent. 

Your Benefit: 

  • One login for sites across all your studies
  • Seamless integration with your existing enterprise credentials
  • Direct response to sites' most common complaint  
  • Reduced onboarding time and training burden 
  1. Study-Agnostic Data Access: Free Your IT Teams

The Challenge: IT groups become bottlenecks, manually setting up data transfers and reports for each protocol without portfolio-level visibility. 

The Solution: APIs that provide access to RTSM data across your entire portfolio without protocol-by-protocol configuration. 

Your Benefit: 

  • Automated go-live processes for site and user management
  • Real-time portfolio dashboards without manual data collection
  • IT teams become enablers rather than bottlenecks 
  1. Standardized Configurations: Stop Reinventing the Wheel

The Challenge: Study teams recreate processes for every protocol, leading to inconsistency and wasted effort. 

The Solution: Controlled design standards built in, with protocol-specific variability only where actually needed. 

Your Benefit: 

  • Consistent integration patterns across all protocols
  • Standardized reporting and operational processes
  • Study teams focus on data analysis instead of administrative overhead
  • Organizational best practices embedded in every implementation  

The Operational Impact: What Changes When You Optimize at Portfolio Scale

When you move from protocol-centric to portfolio-centric operations, transformation happens at every level: 

For Sites: 

  • Dramatically reduced complexity with one login and consistent interfaces 
  • Less time managing credentials, more time with patients
  • Predictable workflows across all your studies

For Study Teams: 

  • Focus on analyzing data in real time instead of administrative tasks
  • Standardized processes that work the same way every time
  • More efficient protocol execution 

For IT Groups: 

  • Become strategic enablers rather than implementation bottlenecks
  • Portfolio-wide data access without repetitive setup
  • Automated processes reduce manual intervention 

For Leadership: 

  • Real-time portfolio visibility across all trials
  • Data-driven decision making at enterprise scale  
  • Your organization operates as a unified research enterprise 

Why Strong RTSM Fundamentals Enable Portfolio Transformation 

This portfolio-level optimization only works when built on a proven RTSM foundation. Signant SmartSignals RTSM brings 25+ years of experience across thousands of trials, including: 

  • Rapid implementation and change management through configurable systems
  • Complex trial support including adaptive designs, direct-to-patient, and cohort management
  • In-house biostatistics team ensuring statistical integrity
  • Integration across the complete Signant ecosystem 

Strong randomization and supply management capabilities remain critical to any RTSM solution. What sets us apart is how we leverage this foundation to transform operations at portfolio scale. 

Moving Forward: From RTSM Vendor to Strategic Operations Partner 

The future of clinical research is data consolidation, standardization, and portfolio-level optimization. As the industry evolves, organizations need partners who bring more than just technology—they need expertise that transforms operations. 

Questions to Ask Yourself 

  • Are protocol-specific implementations preventing portfolio-level efficiency?
  • Could unified identity management reduce site burden and improve retention?
  • Is your IT team spending too much time on repetitive setup tasks?
  • Do you have real-time visibility across your entire trial portfolio?

If you answered yes to any of these questions, it's time to think beyond protocol-specific RTSM. 

 

The Path to Portfolio Optimization 

Breaking down operational silos isn't just about implementing better technology—it's about fundamentally changing how your organization approaches clinical operations. With proven RTSM capabilities and portfolio-level optimization expertise, Signant Health helps you: 

  • Reduce site complexity and improve user experience
  • Eliminate IT bottlenecks with automated data access
  • Standardize processes across your research program
  • Gain executive-level portfolio visibility
  • Transform from managing individual protocols to operating as a unified research enterprise

Ready to optimize your clinical operations at portfolio scale?

 

About the author

Lakshmi GanesanLakshmi Ganesan has over 15 years in technology and product management, and specializes in platform enablement for clinical supply chain solutions. For the past 7+ years at Signant Health, she's been dedicated to advancing clinical supply solutions that power clinical trials worldwide. Her work focuses on building and scaling platforms that streamline RTSM and clinical supply chains, ensuring patients have reliable access to investigational treatments while helping sponsors and CROs navigate the complexities of modern clinical research. Lakshmi is passionate about leveraging technology to remove barriers in clinical trials and accelerate the delivery of life-changing therapies to patients who need them most.

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