You will get Study Design Consultation for Clinical Trial Planning
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Top Rated
Project details
With over a decade of experience in clinical research, I offer expert consultation calls to help you optimize your study design. Whether you need guidance on protocol development, regulatory compliance, or operational feasibility, I provide personalized advice tailored to your study’s needs. During our consultation, I will review your study objectives, methodology, and design, offering actionable recommendations to improve your protocol. I can also advise on FDA and IRB submissions, helping you navigate the regulatory process with confidence. Let’s work together to ensure your study is scientifically rigorous and ready for successful execution.
Industry
Biotech, Health & Medical, Writing & PublishingWhat's included $300
These options are included with the project scope.
$300
- Delivery Time 1 day
- Live Consultation (Minutes) 30
Optional add-ons
You can add these on the next page.
Additional 10 Minutes of Consultation
+$20Frequently asked questions
About Tatiana
Clinical Development & Operations Strategy
100%
Job Success
Highland Park, United States - 3:48 am local time
I am a clinical development and clinical operations consultant who partners with biotech startups to design and execute clinical trials and clinical research programs that actually run.
I work with founders and lean clinical teams as a fractional leader, building practical, executable clinical programs from strategy through clinical trial startup and early-phase development.
With a medical background and 14+ years of experience in clinical research, clinical development, and evidence generation, I bring both scientific depth and operational expertise to every engagement. I understand the medicine, the protocol, and the real world realities of running clinical trials.
My focus is simple: build the structure, systems, and vendor ecosystem that make execution possible across CROs, CDMOs, and regulatory requirements.
Think of me as your clinical program architect.
WHAT I HELP TEAMS DO
✔ Shape clinical development strategy and clinical trial roadmaps
✔ Pressure test protocols and clinical plans
✔ Design operationally realistic clinical trials
✔ Build startup plans, timelines, and budgets
✔ Select and oversee CROs, CDMOs, and vendors
✔ Lead vendor strategy, contracts, and scopes of work
✔ Establish SOPs and scalable clinical operations infrastructure
✔ Design evidence generation strategies for regulatory, payer, and adoption goals
✔ Plan clinical utility, real world evidence, and post market studies
✔ Identify risks early and solve execution gaps
In short, I turn promising science into clinical programs and evidence plans that are ready to execute.
HOW I ENGAGE
🔸 CLINICAL PROGRAM DESIGN AND BUILDOUTS
• Clinical development plans
• Study design and protocol architecture
• Clinical trial startup and operational planning
• Feasibility and risk assessments
• Timelines, budgets, and resourcing models
• SOP and process design
🔸 VENDOR SELECTION AND CONTRACTING
• CRO and CDMO evaluation and selection
• Scope of work development
• Budget modeling and cost control
• Contract and MSA review from an operational perspective
• Work orders and milestone structures
• Vendor oversight and performance management
🔸 EVIDENCE GENERATION AND MEDICAL STRATEGY
• Investigator-Initiated Research Programs
• Clinical utility studies
• Real world evidence programs
• HEOR and payer evidence planning
• Post market studies
• Lifecycle and label expansion strategy
🔸 SENIOR SCIENTIFIC AND CLINICAL WRITING
• Protocols
• Investigator Brochures
• Clinical Study Reports
• Study documentation and strategic reviews
EXPERIENCE SNAPSHOT
✔ MD with strong clinical and scientific foundation
✔ 14+ years in clinical research, clinical development, and medical affairs strategy
✔ Sponsor side and site level clinical operations
✔ Drug, device, biologics, gene therapy, and diagnostic clinical trials
✔ First in human and early phase studies
✔ Rare disease and startup environments
✔ Extensive CRO and vendor oversight
✔ Experienced in contracts, budgets, and scopes of work
✔ Built clinical functions and operational infrastructure from scratch
I specialize in creating the strategy, processes, vendor ecosystem, and evidence plans that allow lean biotech teams to execute like mature organizations.
🔍 KEYWORDS & SKILLS
Clinical Development | Clinical Operations | Clinical Trials | Clinical Research | Clinical Strategy
Clinical Trial Startup | Protocol Design | Study Design | Trial Feasibility | Clinical Program Buildout
Fractional Clinical Leadership | Biotech Consulting | Clinical Operations Strategy | Trial Execution
CRO Selection | CRO Oversight | CDMO Strategy | Vendor Management | Clinical Contracts | Scope of Work Development | Medical Affairs Strategy | Evidence Generation | Real World Evidence (RWE) | HEOR | Clinical Utility Studies | First in Human Trials | Early Phase Trials | Rare Disease Trials | Gene Therapy Trials | Investigator Brochures | Clinical Study Reports | Good Clinical Practice (GCP)
Steps for completing your project
After purchasing the project, send requirements so Tatiana can start the project.
Delivery time starts when Tatiana receives requirements from you.
Tatiana works on your project following the steps below.
Revisions may occur after the delivery date.
Set up Consultation and Review Requirements
We schedule a time for the consultation call. Prior to the meeting, I review the client's requirements and study details to ensure a focused and efficient discussion on their study design.
Consultation Call
We have a live consultation call, where we discuss the study design, objectives, regulatory concerns, and any challenges the client is facing. I provide actionable feedback and recommendations.