Operational Strategy & Process Improvement

Rethinking Clinical Operations for Greater Efficiency

At Yashira Consulting Services, LLC, we specialize in helping sponsors, CROs, and research teams improve the way their clinical trials operate—from the inside out. Whether your study is at the planning stage or already underway, our process improvement consulting services are designed to streamline workflows, eliminate inefficiencies, and support faster, more compliant execution.



Headquartered in the Bronx and serving clients across the U.S., we apply operational strategy consulting with a hands-on, sponsor-aligned approach. Our goal is simple: to optimize your trial’s execution so you can deliver high-quality data on time and on budget.

Why Operational Strategy Matters in Clinical Research

A clinical trial's success often hinges not only on the protocol, but on the systems, communication, and processes behind it. Without a strong operational foundation, even well-designed trials can experience:

• Missed milestones
• Poor site performance
• Budget overruns
• Low team engagement
• Delays in data delivery or database lock
  
  

Strategic planning and continuous process improvement reduce friction across clinical operations, improve collaboration, and strengthen compliance.

Sponsors who invest in operational optimization experience better outcomes, faster recruitment, improved regulatory confidence, and fewer costly rework cycles.

Workflow Assessment and Mapping

We conduct a comprehensive review of your current operational workflows, including:

• Protocol development and review timelines
• Site startup activities
• Communication pathways across teams
• Vendor and CRO interaction models
• Data entry, query resolution, and monitoring schedules
  
  

We then create clear process maps that identify gaps, redundancies, and misalignments.

Bottleneck Identification and Resolution

Delays often stem from overlooked inefficiencies. We help uncover:

• Approval or contracting bottlenecks
• Inefficient meeting structures
• Gaps in documentation or follow-through
• Technology underuse or misalignment
• Poor resource allocation
  
  

Once identified, we work with stakeholders to implement realistic, high-impact changes that address root causes—not just symptoms.

SOP and Role Clarification

Unclear processes lead to inconsistent performance. We offer:

• SOP revision or creation tailored to updated workflows
• Clarified roles and responsibilities across functions
• Job aid development for consistent task execution
• Training materials to support rollout of process improvements
  
  

This improves accountability, communication, and compliance at every level.

Strategic Planning for Growth

Whether you're scaling operations or preparing for new trial phases, we support long-term planning through:

• Team structure design and resourcing models
• Technology tool recommendations and integration plans
• Budget planning with operational alignment
• Communication cadence optimization
• KPI development for operational monitoring
  
  

We help turn strategic goals into actionable execution plans that your team can manage.

Our 5-Phase Process Improvement Model

We follow a proven methodology to evaluate and improve your operations:

1. Discovery & Interviews: We meet with key stakeholders across functions to understand current processes and pain points.
   
   
2. Workflow Mapping: We document workflows, SOPs, systems, and reporting structures.
   
   
3. Gap Analysis: We compare current operations against industry best practices and regulatory expectations.
   
   
4. Improvement Planning: We deliver a practical roadmap with phased implementation strategies.
   
   
5. Support & Follow-Up: We provide coaching, documentation, and monitoring tools to ensure sustainable improvements.
   
   

Each phase is customized to your trial type, company size, and internal team capacity.

When to Call Us In

Our operational strategy and improvement consulting is ideal if you are:

• Launching a new clinical trial and want to get ahead of operational risks
  
• Experiencing delays or budget overages on an active study
  
• Adding new CRO or vendor partners and need clearer coordination models
  
• Transitioning internal teams or expanding capabilities
  
• Revisiting SOPs or training programs after an audit or quality review
  
  

Whether it's a fresh perspective or structured intervention you need, we’re here to support both.

Why Choose Yashira Consulting Services?

• Clinical operations experience in biotech, pharma, and academic research
  
• Hands-on approach to operational change, not just slide decks
  
• Founder-led expertise: Yashira Henriquez brings direct experience from highly reputable organizations.
  
• Emphasis on diversity and equity in operational design and communication
  
• Bilingual English-Spanish services to improve inclusion and coordination
  
  

We don’t just consult—we collaborate, troubleshoot, and implement. Our goal is to leave your team stronger, your workflows smoother, and your trials more efficient.

Let’s Improve How Your Trials Run

If your clinical operations could benefit from more structure, clarity, or speed, we’re ready to help. Yashira Consulting Services, LLC provides the strategic insight and hands-on support you need to reduce delays, enhance collaboration, and improve trial outcomes.