Clinical Trial Consulting Services



Comprehensive Support for Every Phase of Your Clinical Trial
At Yashira Consulting Services, LLC, we help sponsors, CROs and academic research institutes protect the integrity of their clinical trials through robust regulatory compliance and quality assurance (QA) consulting. With ever-evolving FDA, EMA, and ICH-GCP requirements, trial sponsors must be proactive in maintaining inspection readiness, documentation accuracy, and operational transparency.
From feasibility assessments and SOP development to CRO coordination and site oversight, our expertise enables you to stay on schedule, on budget, and in compliance with evolving regulatory standards. Whether you're conducting an early-phase study or preparing for closeout, we provide hands-on solutions that align with your team, goals, and values.
Our Core Clinical Consulting Services
We offer a full suite of services that address every operational need in modern clinical research. Each offering is customized to your protocol, therapeutic area, study phase, and regulatory environment.
Clinical Trial Management & Planning
Primary Focus: Laying the foundation for efficient and successful studies.
- Protocol feasibility reviews
- Resource planning and budgeting
- Timeline development
- Risk identification and mitigation
- Investigator meeting preparation
Our consultants help you navigate complexities early on—ensuring alignment between internal stakeholders, study goals, and execution strategy. With experience across Phase I–IV studies, we know how to anticipate challenges and adapt accordingly.
CRO Coordination & Sponsor Support
Primary Focus: Ensuring smooth collaboration and oversight between sponsors and CROs.
- Vendor selection support
- Metrics tracking and performance reviews
- Communication streamlining
- Compliance with sponsor expectations
- Continuous issue resolution
We serve as an extension of your internal team, managing communications with CROs, escalating concerns, and providing strategic guidance to ensure expectations are met.
Site Selection & Patient Recruitment
Primary Focus: Enhancing site performance and participant engagement.
- Site feasibility assessments
- Outreach strategies to diverse communities
- Recruitment material development
- Community-based site engagement
- Enrollment tracking and retention support
With a strong emphasis on diversity, equity, and inclusion, we help you identify high-performing sites and design culturally competent recruitment approaches that lead to higher retention and better data quality.
Regulatory Compliance & Quality Assurance
Primary Focus: Mitigating risk while upholding GCP and regulatory standards.
- SOP development and review
- Audit readiness assessments
- GCP training coordination
- Document control systems setup
- Deviation tracking and CAPA support
We ensure your trial documents, systems, and procedures meet FDA, EMA, and ICH-GCP expectations—supporting both inspections and internal audits with confidence.
Operational Strategy & Process Improvement
Primary Focus: Improving trial efficiency and team alignment.
- Workflow analysis and optimization
- Bottleneck identification
- Technology tool evaluation
- Performance metric dashboards
- Stakeholder communication plans
We apply practical strategies to improve how your trial team functions day-to-day—reducing delays, increasing data quality, and improving sponsor-site collaboration.
Our Process
We follow a structured yet flexible consulting model to ensure consistent results across projects:
- Discovery: We begin with a detailed intake session to understand your trial objectives, current systems, timelines, and resource needs.
- Assessment: We analyze your protocol, workflows, site list, or vendor partners to identify gaps and opportunities.
- Recommendation: We deliver an actionable plan tailored to your trial scope and phase.
- Execution Support: We work directly with your internal team, sites, or vendors to implement improvements, manage progress, and ensure quality.
- Ongoing Optimization: We monitor and adjust strategies to adapt to changes in recruitment, regulatory requirements, or study direction.
Why Choose Yashira Consulting Services?
Clients choose Yashira Consulting Services, LLC for our strategic insight, commitment to quality, and community-driven approach. Unlike larger firms that offer a templated experience, we provide:
- Hands-on founder involvement
- Proven experience across trial phases
- Responsive communication and problem-solving
- Bilingual services (English/Spanish)
- Experience with small to mid-sized sponsors
Our team is deeply invested in helping your study run efficiently, ethically, and inclusively.
Industries We Serve
Our clinical trial consulting services are built to support:
- Biotechnology companies conducting early- or late-phase research
- Pharmaceutical firms scaling large, multi-center trials
- Academic research centers launching investigator-led studies
- CROs seeking trial oversight, coordination, or vendor support
- Health equity organizations expanding community-based trials
From niche studies to complex, multi-site programs, we tailor support based on your infrastructure, therapeutic focus, and trial design.
Get Started with Us
Whether you're planning your first study or managing a portfolio of trials, Yashira Consulting Services, LLC can help you elevate your operations and outcomes.

Let us show you how our services can support your goals while keeping your research compliant, efficient, and inclusive.