Clarity today, approvals
tomorrow.
tomorrow.
Clinical Operations
We evaluate, design, and lead clinical programmes from pre-IND through late phase, with a focus on operational risk, governance, and capital efficiency.
Clarity today, approvals
tomorrow.
tomorrow.
Clinical Operations
We evaluate, design, and lead clinical programmes from pre-IND through late phase, with a focus on operational risk, governance, and capital efficiency.
Clarity today, approvals
tomorrow.
tomorrow.
our mission
Strong science fails when execution assumptions go unchallenged.
Lights On Consultancy work with founders, CMOs, boards, and investors to independently assess clinical programmes, design fit-for-purpose operational strategies, and build operational structures to support scalibility and withstand regulatory and investor scrutiny.
Pre-IND to IND Readiness
First in Clinical to Late Phase Escability
HealthTech, Biotech and Data Overlaps
Due Diligence for Investors and Boards
our mission
Strong science fails when execution assumptions go unchallenged.
Lights On Consultancy work with founders, CMOs, boards, and investors to independently assess clinical programmes, design fit-for-purpose operational strategies, and build operational structures to support scalibility and withstand regulatory and investor scrutiny.
Pre-IND to IND Readiness
First in Clinical to Late Phase Escability
HealthTech, Biotech and Data Overlaps
Due Diligence for Investors and Boards
our mission
Strong science fails when execution assumptions go unchallenged.
Lights On Consultancy work with founders, CMOs, boards, and investors to independently assess clinical programmes, design fit-for-purpose operational strategies, and build operational structures to support scalibility and withstand regulatory and investor scrutiny.
Pre-IND to IND Readiness
First in Clinical to Late Phase Escability
HealthTech, Biotech and Data Overlaps
Due Diligence for Investors and Boards
Pre-Seed to IND
Supporting early-stage companies in translating scientific vision into an execution plan that withstands investor scrutiny.
Design of capital-efficient clinical development roadmaps aligned to value inflection points
Definition of core governance, operating model, and early clinical infrastructure
Independent stress-testing of timelines, budgets, and development assumptions prior to fundraising
only 10-15%
investigational drug candidates that enter clinical testing ultimately receive approval
96%
Improvement in real-world research outcomes
62%
Decrease in erroneous false-positives in large data sets.
First in Clinical to Late Phase Escability
Preparing programmes for IND submission, first-in-human studies, and early clinical execution with operational discipline
IND readiness assessment and regulatory-facing operational strategy
Protocol feasibility review, recruitment modelling, and vendor ecosystem design
Establishment of SOP architecture, oversight cadence, and inspection-ready documentation standards
~62%
of VC rounds in 2025 were for clinical-stage companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
HealthTech, Biotech and Data Overlaps
Bridging clinical development with digital health, real-world data, and advanced analytics in pharmaceutical and device programmes.
Integration of real-world evidence and secondary data into clinical strategy
Operational evaluation of digital components, decentralised elements, and data flow architecture
Alignment of clinical endpoints, evidence generation, and regulatory positioning across drug, device, and combination pathways
512
The number of clinical trials in digital health in the first half of 2024 alone
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Due Diligence for Venture Capital and Investment Banks
Providing independent clinical operations due diligence and execution risk assessment before capital deployment or transaction.
Objective review of trial design quality, operational feasibility, and enrolment assumptions
Assessment of timeline credibility, vendor structure, and budget realism
Clear articulation of execution risk, mitigation pathways, and capital exposure
only 7%
global health biotech VC investment goes to European based companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Pre-Seed to IND
Supporting early-stage companies in translating scientific vision into an execution plan that withstands investor scrutiny.
Design of capital-efficient clinical development roadmaps aligned to value inflection points
Definition of core governance, operating model, and early clinical infrastructure
Independent stress-testing of timelines, budgets, and development assumptions prior to fundraising
only 10-15%
investigational drug candidates that enter clinical testing ultimately receive approval
96%
Improvement in real-world research outcomes
62%
Decrease in erroneous false-positives in large data sets.
First in Clinical to Late Phase Escability
Preparing programmes for IND submission, first-in-human studies, and early clinical execution with operational discipline
IND readiness assessment and regulatory-facing operational strategy
Protocol feasibility review, recruitment modelling, and vendor ecosystem design
Establishment of SOP architecture, oversight cadence, and inspection-ready documentation standards
~62%
of VC rounds in 2025 were for clinical-stage companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
HealthTech, Biotech and Data Overlaps
Bridging clinical development with digital health, real-world data, and advanced analytics in pharmaceutical and device programmes.
Integration of real-world evidence and secondary data into clinical strategy
Operational evaluation of digital components, decentralised elements, and data flow architecture
Alignment of clinical endpoints, evidence generation, and regulatory positioning across drug, device, and combination pathways
512
The number of clinical trials in digital health in the first half of 2024 alone
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Due Diligence for Venture Capital and Investment Banks
Providing independent clinical operations due diligence and execution risk assessment before capital deployment or transaction.
Objective review of trial design quality, operational feasibility, and enrolment assumptions
Assessment of timeline credibility, vendor structure, and budget realism
Clear articulation of execution risk, mitigation pathways, and capital exposure
only 7%
global health biotech VC investment goes to European based companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Pre-Seed to IND
Supporting early-stage companies in translating scientific vision into an execution plan that withstands investor scrutiny.
Design of capital-efficient clinical development roadmaps aligned to value inflection points
Definition of core governance, operating model, and early clinical infrastructure
Independent stress-testing of timelines, budgets, and development assumptions prior to fundraising
only 10-15%
investigational drug candidates that enter clinical testing ultimately receive approval
96%
Improvement in real-world research outcomes
62%
Decrease in erroneous false-positives in large data sets.
First in Clinical to Late Phase Escability
Preparing programmes for IND submission, first-in-human studies, and early clinical execution with operational discipline
IND readiness assessment and regulatory-facing operational strategy
Protocol feasibility review, recruitment modelling, and vendor ecosystem design
Establishment of SOP architecture, oversight cadence, and inspection-ready documentation standards
~62%
of VC rounds in 2025 were for clinical-stage companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
HealthTech, Biotech and Data Overlaps
Bridging clinical development with digital health, real-world data, and advanced analytics in pharmaceutical and device programmes.
Integration of real-world evidence and secondary data into clinical strategy
Operational evaluation of digital components, decentralised elements, and data flow architecture
Alignment of clinical endpoints, evidence generation, and regulatory positioning across drug, device, and combination pathways
512
The number of clinical trials in digital health in the first half of 2024 alone
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Due Diligence for Venture Capital and Investment Banks
Providing independent clinical operations due diligence and execution risk assessment before capital deployment or transaction.
Objective review of trial design quality, operational feasibility, and enrolment assumptions
Assessment of timeline credibility, vendor structure, and budget realism
Clear articulation of execution risk, mitigation pathways, and capital exposure
only 7%
global health biotech VC investment goes to European based companies
96%
Decrease in erroneous false-positives in large data sets.
62%
Decrease in erroneous false-positives in large data sets.
Behind Lights On
Pedro Testi is the founder of Lights On, a clinical operations advisory focused on building inspection-ready, scalable infrastructure for early-stage biotech and medtech companies.
With over 12 years of experience across oncology, immunology, fertility and health technology, he has led global clinical programmes at AstraZeneca and Merck under active regulatory scrutiny.
His experience spans pre-IND planning through late-phase execution, including delivery of NDA packages and leadership of multiple global inspections across FDA, EMA, MHRA and PMDA environments.
Through Lights On, he works directly with founders, CMOs and investors to establish proportionate governance models, strengthen CRO oversight, and align clinical strategy with operational feasibility.
Behind Lights On
Pedro Testi is the founder of Lights On, a clinical operations advisory focused on building inspection-ready, scalable infrastructure for early-stage biotech and medtech companies.
With over 12 years of experience across oncology, immunology, fertility and health technology, he has led global clinical programmes at AstraZeneca and Merck under active regulatory scrutiny.
His experience spans pre-IND planning through late-phase execution, including delivery of NDA packages and leadership of multiple global inspections across FDA, EMA, MHRA and PMDA environments.
Through Lights On, he works directly with founders, CMOs and investors to establish proportionate governance models, strengthen CRO oversight, and align clinical strategy with operational feasibility.
Behind Lights On
Pedro Testi is the founder of Lights On, a clinical operations advisory focused on building inspection-ready, scalable infrastructure for early-stage biotech and medtech companies.
With over 12 years of experience across oncology, immunology, fertility and health technology, he has led global clinical programmes at AstraZeneca and Merck under active regulatory scrutiny.
His experience spans pre-IND planning through late-phase execution, including delivery of NDA packages and leadership of multiple global inspections across FDA, EMA, MHRA and PMDA environments.
Through Lights On, he works directly with founders, CMOs and investors to establish proportionate governance models, strengthen CRO oversight, and align clinical strategy with operational feasibility.
Our Impact
Shaping the future of biotech and AI
We deliver intelligent solutions that transform industries, improve lives, and power tomorrow's breakthroughs.
13+
Companies advised
Our Impact
Shaping the future of biotech and AI
We deliver intelligent solutions that transform industries, improve lives, and power tomorrow's breakthroughs.
13+
Companies advised
Our Impact
Shaping the future of biotech and AI
We deliver intelligent solutions that transform industries, improve lives, and power tomorrow's breakthroughs.
13+
Companies advised
Tomorrow’s challenges demand today’s boldest ideas. Light On mission is to support science with clinical operational excellence —bridging sciences and operations.
At Light On, we believe that science is not static—it’s a system in motion. Our mission is to help the world’s most ambitious teams turn research into reality by designing intelligent, adaptive frameworks that move ideas forward. We don’t just consult. We collaborate. We work side by side with scientists, engineers, strategists, and visionaries to navigate complexity with clarity, and to architect systems that scale discovery into impact. Light On exists to push possibility into practice.
This is what drives us: finding the perfect balance between clinical operational pragmatism and excellence. We believe that innovation doesn’t happen by chance; it happens when science meets execution, and when bold thinking is paired with operational discipline. That’s our credo. We bring deep expertise, radical focus, and systems-level thinking to every challenge. .
Pedro Testi
Lights On Consultancy
Tomorrow’s challenges demand today’s boldest ideas. Light On mission is to support science with clinical operational excellence —bridging sciences and operations.
At Light On, we believe that science is not static—it’s a system in motion. Our mission is to help the world’s most ambitious teams turn research into reality by designing intelligent, adaptive frameworks that move ideas forward. We don’t just consult. We collaborate. We work side by side with scientists, engineers, strategists, and visionaries to navigate complexity with clarity, and to architect systems that scale discovery into impact. Light On exists to push possibility into practice.
This is what drives us: finding the perfect balance between clinical operational pragmatism and excellence. We believe that innovation doesn’t happen by chance; it happens when science meets execution, and when bold thinking is paired with operational discipline. That’s our credo. We bring deep expertise, radical focus, and systems-level thinking to every challenge. .
Pedro Testi
Lights On Consultancy
Tomorrow’s challenges demand today’s boldest ideas. Light On mission is to support science with clinical operational excellence —bridging sciences and operations.
At Light On, we believe that science is not static—it’s a system in motion. Our mission is to help the world’s most ambitious teams turn research into reality by designing intelligent, adaptive frameworks that move ideas forward. We don’t just consult. We collaborate. We work side by side with scientists, engineers, strategists, and visionaries to navigate complexity with clarity, and to architect systems that scale discovery into impact. Light On exists to push possibility into practice.
This is what drives us: finding the perfect balance between clinical operational pragmatism and excellence. We believe that innovation doesn’t happen by chance; it happens when science meets execution, and when bold thinking is paired with operational discipline. That’s our credo. We bring deep expertise, radical focus, and systems-level thinking to every challenge. .
Pedro Testi
Lights On Consultancy