Clinical Trial Management & Planning Services
Introduction to Clinical Trial Management
Efficient clinical trial management is the cornerstone of successful drug development. At Yashira Consulting Services, LLC, we provide hands-on clinical trial management and planning services that help sponsors and CROs execute timely, compliant, and high-quality studies. Based in the Bronx, we work with biotechnology firms, pharmaceutical companies, and academic researchers to design and manage trials that are built for success from day one.
Whether you’re preparing for first-in-human studies or expanding into multi-center trials, we bring deep operational experience and strategic oversight to every step of the process. Our consulting services ensure your study is not only feasible and compliant—but also scalable and inclusive.
Why Clinical Trial Planning Matters
Too often, clinical trials encounter delays, budget overruns, or protocol deviations due to poor planning. Strategic planning at the earliest stages of your study can prevent downstream issues that impact regulatory approval, site performance, and patient enrollment.
Effective planning allows sponsors to:
- Accurately estimate resource needs and timelines
- Develop realistic recruitment goals
- Align internal and external teams
- Proactively identify risks
- Ensure GCP and regulatory compliance from the start
Yashira Consulting Services is here to help you develop a plan that aligns with your trial goals, stakeholder needs, and regulatory environment.
Our Clinical Trial Management Services
We offer full-spectrum support to optimize the planning, coordination, and daily oversight of your clinical research program.
Feasibility Assessments
We conduct detailed assessments of trial protocols, timelines, and enrollment expectations. This includes:
- Site capability evaluation
- Population availability analysis
- Competitive landscape review
- Operational complexity scoring
- Budget and resource planning support
These insights help determine whether your trial is operationally realistic and where adjustments may be needed.
Study Startup Planning
We coordinate all aspects of study startup, including:
- Regulatory and ethics submission timelines
- Contract and budget negotiations
- Site initiation materials and training
- Investigator meeting planning
- Trial master file setup
With a structured and streamlined startup process, your study launches faster and with fewer administrative obstacles.
Project Management Oversight
We provide end-to-end clinical project oversight to keep timelines and teams aligned:
- Gantt chart and timeline development
- Role clarification and communication mapping
- Task ownership tracking
- Recruitment performance monitoring
- Issue escalation and resolution pathways
Our systems ensure that every task is assigned, every risk is tracked, and every milestone is met.
Protocol and SOP Guidance
We review and advise on key trial documents including:
- Study protocols and amendments
- Informed consent forms
- Standard operating procedures (SOPs)
- Data management plans
- Trial closeout documentation
Our input ensures your documentation is both operationally viable and regulatory-ready.
Our Planning Process
Our proven approach ensures planning leads to real results:
- Protocol Review: We analyze your study design, endpoints, and complexity.
- Feasibility Scoping: We identify timelines, budget alignment, and potential risks.
- Startup Strategy: We outline submission, contracting, and site activation pathways.
- Execution Framework: We create a timeline, assign responsibilities, and monitor KPIs.
- Ongoing Support: We remain available to course-correct as needed, minimizing mid-trial disruptions.
This framework ensures your trial has the structure, systems, and support it needs from day one.
Who We Support
Our clinical trial management and planning services are ideal for:
- Biotech startups preparing for IND submission or first-in-human trials
- Mid-sized pharma needing expert oversight without expanding headcount
- Academic institutions running investigator-initiated studies
- CROs managing multiple sponsor projects simultaneously
- Diversity-focused research groups requiring community-aligned planning
No matter your size or scope, we customize support to match your protocol, resources, and strategic goals.
Why Choose Yashira Consulting Services?
- Founder-led expertise: Yashira Henriquez brings direct experience from highly reputable organizations.
- Regulatory alignment: We prioritize FDA and GCP standards in all planning materials.
- Cultural competence: We tailor recruitment and planning to reflect diverse patient populations.
- Hands-on delivery: We go beyond advice—we help execute, track, and improve your trial management process.
Bronx-based agility: Our location gives us firsthand insight into community-centered research planning.
Let’s Plan Your Next Trial
Start your clinical trial off on the right foot with expert planning and oversight. Whether you're in early startup or seeking a strategic reset mid-trial, Yashira Consulting Services, LLC can help.