Expert Consulting for Efficient Clinical Trial Execution
Accelerate Your Clinical Trials Today
Expert Consulting for Efficient Clinical Trial Execution
Accelerate Your Clinical Trials Today
Expert Consulting for Efficient Clinical Trial Execution
Accelerate Your Clinical Trials Today
Trusted by Medtech Startups
Trusted by Medtech Startups
Streamlining clinical development from first-in-human to real-world evidence.
We deliver high-impact, ethically sound, and scientifically credible clinical evidence for innovative medical technologies. Let’s turn your clinical vision into reality - on time and on budget.
Building long-term partnerships to accelerate clinical success.
We work closely with your team to design and execute impactful clinical development strategies - leveraging deep expertise, trusted relationships, and a shared commitment to success.
“We are committed to delivering precise, well-researched clinical guidance that empowers medtech startups and healthcare innovators to design and execute efficient, scientifically sound programs - driving regulatory approvals and successful commercialization.”
“We are committed to delivering precise, well-researched clinical guidance that empowers medtech startups and healthcare innovators to design and execute efficient, scientifically sound programs - driving regulatory approvals and successful commercialization.”
Anna K. Gawlicka, PhD, MBA
Anna K. Gawlicka, PhD, MBA
President & Chief Clinical Officer,
President & Chief Clinical Officer,
Innovative Clinical Strategies, LLC
Innovative Clinical Strategies, LLC
Helping medtech startups bring innovations to market
Putting the right solutions and methods in place.
Early-stage development
01
Pivotal trials & global expansion
02
Trial start-up & execution
03
Trial oversight & quality assurance
04
Regulatory & market support
05
Early-stage development
Transforming bold ideas into viable clinical plans.
Helping medtech startups bring innovations to market
Putting the right solutions and methods in place.
Early-stage development
01
Pivotal trials & global expansion
02
Trial start-up & execution
03
Trial oversight & quality assurance
04
Regulatory & market support
05
Early-stage development
Transforming bold ideas into viable clinical plans.
Helping medtech startups bring innovations to market
Putting the right solutions and methods in place.
Early-stage development
01
Pivotal trials & global expansion
02
Trial start-up & execution
03
Trial oversight & quality assurance
04
Regulatory & market support
05
Early-stage development
Transforming bold ideas into viable clinical plans.
Clinical expertise from strategies to publications
Whether you’re launching a first-in-human trial or scaling a post-market registry, we tailor our approach to meet your unique goals.
Aligned with objectives for market expansions, read regulatory approvals & reimbursement positioning
Addressing all stakeholders’ needs
Supporting clinical effectiveness & safety
Maximizing trial success
Planning: protocol, budget, timeline
Development: IRB/IEC approval, site contract negotiations
Execution: enrollment, monitoring
Closure: data collection & analysis
Trial management per project management
CRO management
Clinical QC & QA
Biostatistical programming & analysis
Sensitivity analysis
Cost-effectiveness analysis
Survey design & analysis
Strategy development
Manuscript preparation, submission & revision
Preparation of clinical sections & ISS/ISE for regulatory submissions
Publications
Data Analytics
Clinical Trials
Clinical Strategies
Aligned with objectives for market expansions, read regulatory approvals & reimbursement positioning
Addressing all stakeholders’ needs
Supporting clinical effectiveness & safety
Maximizing trial success
Planning: protocol, budget, timeline
Development: IRB/IEC approval, site contract negotiations
Execution: enrollment, monitoring
Closure: data collection & analysis
Trial management per project management
CRO management
Clinical QC & QA
Biostatistical programming & analysis
Sensitivity analysis
Cost-effectiveness analysis
Survey design & analysis
Strategy development
Manuscript preparation, submission & revision
Preparation of clinical sections & ISS/ISE for regulatory submissions
Publications
Data Analytics
Clinical Trials
Clinical Strategies
Aligned with objectives for market expansions, regulation approvals & reimbursement positioning
Addressing all stakeholders’ needs
Supporting clinical effectiveness & safety
Maximizing trial success
Planning: protocol, budget, timeline
Development: IRB/IEC approval, site contract negotiations
Execution: enrollment, monitoring
Closure: data collection & analysis
Trial management per project management
CRO management
Clinical QC & QA
Clinical Trials
Clinical Strategies
Biostatistical programming & analysis
Sensitivity analysis
Cost-effectiveness analysis
Survey design & analysis
Data Analytics
Publications
Strategy development
Manuscript preparation, submission & revision
Preparation of clinical sections & ISS/ISE for regulatory submissions
Track record of successful trials
15
Feasibility trials
Community
members
19
Pivotal trials
20
Postmarket surveillance
“I’ve worked with Anna on several projects over more than a decade, advancing ENT medical innovations from concept to widespread clinical application. She brings sharp insight unwavering integrity, and a rare ability to turn complex challenges into successful clinical outcomes. I can’t think of anyone more capable.”
Simon Wright, MD, PhD, FACS
Physician/Professor of Surgeon, Iowa ENT Center
“Anna’s clinical insight, leadership, and collaborative spirit were pivotal in driving our efforts toward successful regulatory approvals and impactful publications. It was truly a pleasure collaborating with Anna, and I look forward to seeing the positive impact she’ll continue to make in the field.”
J. Pablo Stolovitzky, MD
CEO, ENT of Georgia. Clinical Faculty, Emory University School of Medicine
“I had the pleasure of working with Anna on several breakthrough clinical programs, including EsophyX, and GT Metabolic Magnetic Anastomosis System. Anna brings a rare combination of energy, can do attitude, clinical insight, executional discipline, and strategic thinking—she played a pivotal role in shaping the clinical path for these technologies in the start-up environment”
Thierry B. Thaure
CEO, GT Metabolic Solutions
“Anna brings exceptional expertise in clinical trial design across multiple therapeutic areas, paired with a sharp sense of business strategy—a rare and powerful combination. Beyond her impressive credentials, she has a unique talent for building and inspiring high-performing teams. Anyone who has worked with Anna would gladly do so again.”
James E. Kallman, MD, FACS
Head-Neck Surgeon & Medical Advisor
“I’ve worked with Anna on several projects over more than a decade, advancing ENT medical innovations from concept to widespread clinical application. She brings sharp insight unwavering integrity, and a rare ability to turn complex challenges into successful clinical outcomes. I can’t think of anyone more capable.”
Simon Wright, MD, PhD, FACS
Physician/Professor of Surgeon, Iowa ENT Center
“Anna’s clinical insight, leadership, and collaborative spirit were pivotal in driving our efforts toward successful regulatory approvals and impactful publications. It was truly a pleasure collaborating with Anna, and I look forward to seeing the positive impact she’ll continue to make in the field.”
J. Pablo Stolovitzky, MD
CEO, ENT of Georgia. Clinical Faculty, Emory University School of Medicine
“I had the pleasure of working with Anna on several breakthrough clinical programs, including EsophyX, and GT Metabolic Magnetic Anastomosis System. Anna brings a rare combination of energy, can do attitude, clinical insight, executional discipline, and strategic thinking—she played a pivotal role in shaping the clinical path for these technologies in the start-up environment”
Thierry B. Thaure
CEO, GT Metabolic Solutions
“Anna brings exceptional expertise in clinical trial design across multiple therapeutic areas, paired with a sharp sense of business strategy—a rare and powerful combination. Beyond her impressive credentials, she has a unique talent for building and inspiring high-performing teams. Anyone who has worked with Anna would gladly do so again.”
James E. Kallman, MD, FACS
Head-Neck Surgeon & Medical Advisor