Expert Advisory · US Market
Expert Advisory ·
US Market
US Market
Real-world evidence, health economics, and clinical trial analytics delivered with senior accountability, transparent methodology, and integrated thinking across the full development lifecycle.
Dr. Punekar works alongside your existing team, providing domain expertise and synthesis methodology.
9 services. 3 challenges. 1 advisory model.
Challenge 1
Challenge 2
Challenge 3
DESIGNING TRIALS THAT REFLECT THE REAL WORLD
Clinical trials consistently underperform on enrollment because they are designed in isolation from disease epidemiology. These are design failures, not execution failures, and they are preventable.
Disease Epidemiology Intelligence
Challenge
Prevalence and incidence estimates are pulled from commercial platforms with no visible audit trail, or from a single published study without methodology comparison. When FDA asks for the epidemiological basis for the enrollment target or the Diversity Action Plan, the methodology behind the estimates cannot be produced.
What You Get
Traceable disease epidemiology synthesis with documented methodology, rationale, and source audit trail
Recommended estimates with uncertainty ranges and comparator source assessment
Epidemiology-to-trial-design linkage documentation structured for regulatory review or governance presentation
Patient, Site, and Investigator Sizing and Mapping
Challenge
The protocol's I/E criteria have not been translated into RWD-executable patient identification logic. It is not known which criteria produce the greatest patient attrition. Site selection has been driven by investigator relationships rather than a systematic assessment of where eligible patients are concentrated. The mismatch surfaces during enrollment, not before it.
What You Get
Patient eligibility framework with sizing rationale and eligibility loss analysis by I/E criterion
Site and investigator prioritization methodology linked to patient geography
Protocol optimization input identifying the highest-attrition criteria for sponsor consideration
Diversity and Representation Intelligence
Challenge
FDA Diversity Action Plans are required for the trial. There is no systematic way to assess whether the planned enrollment strategy will produce a sample representative of the disease population across race, ethnicity, geography, and age, or how to correct it when it will not.
What You Get
Population representativeness assessment with demographic synthesis linked to enrollment strategy
Gap analysis identifying underrepresented subgroups and contributing eligibility or site factors
Mitigation recommendations structured for FDA Diversity Action Plan submission, with Census-based population benchmarks
9 services.
3 challenges.
1 advisory model.
9 services. 3 challenges. 1 advisory model.
Challenge 1
Challenge 2
Challenge 3
DESIGNING TRIALS THAT REFLECT THE REAL WORLD
Clinical trials consistently underperform on enrollment because they are designed in isolation from disease epidemiology. These are design failures, not execution failures, and they are preventable.
Disease Epidemiology Intelligence
Challenge
Prevalence and incidence estimates are pulled from commercial platforms with no visible audit trail, or from a single published study without methodology comparison. When FDA asks for the epidemiological basis for the enrollment target or the Diversity Action Plan, the methodology behind the estimates cannot be produced.
What You Get
Traceable disease epidemiology synthesis with documented methodology, rationale, and source audit trail
Recommended estimates with uncertainty ranges and comparator source assessment
Epidemiology-to-trial-design linkage documentation structured for regulatory review or governance presentation
Patient, Site, and Investigator Sizing and Mapping
Challenge
The protocol's I/E criteria have not been translated into RWD-executable patient identification logic. It is not known which criteria produce the greatest patient attrition. Site selection has been driven by investigator relationships rather than a systematic assessment of where eligible patients are concentrated. The mismatch surfaces during enrollment, not before it.
What You Get
Patient eligibility framework with sizing rationale and eligibility loss analysis by I/E criterion
Site and investigator prioritization methodology linked to patient geography
Protocol optimization input identifying the highest-attrition criteria for sponsor consideration
Diversity and Representation Intelligence
Challenge
FDA Diversity Action Plans are required for the trial. There is no systematic way to assess whether the planned enrollment strategy will produce a sample representative of the disease population across race, ethnicity, geography, and age, or how to correct it when it will not.
What You Get
Population representativeness assessment with demographic synthesis linked to enrollment strategy
Gap analysis identifying underrepresented subgroups and contributing eligibility or site factors
Mitigation recommendations structured for FDA Diversity Action Plan submission, with Census-based population benchmarks
9 services.
3 challenges.
1 advisory model.
9 services. 3 challenges. 1 advisory model.
Challenge 1
Challenge 2
Challenge 3
DESIGNING TRIALS THAT REFLECT THE REAL WORLD
Clinical trials consistently underperform on enrollment because they are designed in isolation from disease epidemiology. These are design failures, not execution failures, and they are preventable.
Disease Epidemiology Intelligence
Challenge
Prevalence and incidence estimates are pulled from commercial platforms with no visible audit trail, or from a single published study without methodology comparison. When FDA asks for the epidemiological basis for the enrollment target or the Diversity Action Plan, the methodology behind the estimates cannot be produced.
What You Get
Traceable disease epidemiology synthesis with documented methodology, rationale, and source audit trail
Recommended estimates with uncertainty ranges and comparator source assessment
Epidemiology-to-trial-design linkage documentation structured for regulatory review or governance presentation
Patient, Site, and Investigator Sizing and Mapping
Challenge
The protocol's I/E criteria have not been translated into RWD-executable patient identification logic. It is not known which criteria produce the greatest patient attrition. Site selection has been driven by investigator relationships rather than a systematic assessment of where eligible patients are concentrated. The mismatch surfaces during enrollment, not before it.
What You Get
Patient eligibility framework with sizing rationale and eligibility loss analysis by I/E criterion
Site and investigator prioritization methodology linked to patient geography
Protocol optimization input identifying the highest-attrition criteria for sponsor consideration
Diversity and Representation Intelligence
Challenge
FDA Diversity Action Plans are required for the trial. There is no systematic way to assess whether the planned enrollment strategy will produce a sample representative of the disease population across race, ethnicity, geography, and age, or how to correct it when it will not.
What You Get
Population representativeness assessment with demographic synthesis linked to enrollment strategy
Gap analysis identifying underrepresented subgroups and contributing eligibility or site factors
Mitigation recommendations structured for FDA Diversity Action Plan submission, with Census-based population benchmarks
9 services.
3 challenges.
1 advisory model.
What Clients can Expect
Senior Accountability
Dr. Punekar leads every engagement from scoping through final deliverable. No transfer to a project team after the initial conversation.
Synthesis Expertise
Fragmented data, including publicly available sources, synthesized into coherent, defensible evidence.
Traceable Methodology
Every estimate and recommendation accompanied by source documentation, methodological rationale, and explicit assumptions.
Vendor-Agnostic Counsel
No preferred vendor relationships. No proprietary data network. Recommendations determined solely by fitness for the specific question.
Integrated thinking
Outputs structured for regulatory submission, HTA dossier use, or governance presentation from draft one.
Have a question? Reach us directly.
What Clients can Expect
Senior Accountability
Dr. Punekar leads every engagement from scoping through final deliverable. No transfer to a project team after the initial conversation.
Synthesis Expertise
Fragmented data, including publicly available sources, synthesized into coherent, defensible evidence.
Traceable Methodology
Every estimate and recommendation accompanied by source documentation, methodological rationale, and explicit assumptions.
Vendor-Agnostic Counsel
No preferred vendor relationships. No proprietary data network. Recommendations determined solely by fitness for the specific question.
Integrated thinking
Outputs structured for regulatory submission, HTA dossier use, or governance presentation from draft one.
Have a question? Reach us directly.
What Clients can Expect
Senior Accountability
Dr. Punekar leads every engagement from scoping through final deliverable. No transfer to a project team after the initial conversation.
Synthesis Expertise
Fragmented data, including publicly available sources, synthesized into coherent, defensible evidence.
Expert access throughout
Every estimate and recommendation accompanied by source documentation, methodological rationale, and explicit assumptions.
Transparent methodology
No preferred vendor relationships. No proprietary data network. Recommendations determined solely by fitness for the specific question.
Integrated thinking
Outputs structured for regulatory submission, HTA dossier use, or governance presentation from draft one.
Have a question? Reach us directly.
How to Get Started
Step 1 - Initial Enquiry
Info@novidaanalytics.com. We respond within 2 business days
Step 2 - Discovery Call.
30 to 45 minutes. No obligation.
Step 3 - Scoping Proposal.
Written proposal within 5 business days of discovery call.
Step 4 - Agreement and Kickoff.
Engagement agreement signed. Advisory work begins.
How to Get Started
Step 1 - Initial Enquiry
Info@novidaanalytics.com. We respond within 2 business days
Step 2 - Discovery Call
30 to 45 minutes. No obligation.
Step 3 - Scoping Proposal
Written proposal within 5 business days of discovery call.
Step 4 - Agreement and Kickoff
Engagement agreement signed. Advisory work begins.
How to Get Started
Step 1 - Initial Enquiry
Info@novidaanalytics.com. We respond within 2 business days
Step 2 - Discovery Call.
30 to 45 minutes. No obligation.
Expert access throughout
Written proposal within 5 business days of discovery call.
Transparent methodology
Engagement agreement signed. Advisory work begins.
Pilot Engagement Programme
Early access. Structured and limited.
Novida is developing a structured paid pilot programme providing select clients early access to proprietary analytical frameworks.
Limited to 2–3 simultaneous pilots by design.
Embedded Consulting Pilots
Consulting outcomes delivered using Novida’s internal analytical frameworks at standard consulting rates.
Co-Development Pilots
Working prototype access at preferential rates in exchange for structured feedback on data products in development.
Early Access Subscriptions
Recurring access to data products at early-partner pricing, with feedback sessions shaping product development.
Pilot Engagement Programme
Early access. Structured and limited.
Novida is developing a structured paid pilot programme providing select clients early access to proprietary analytical frameworks.
Limited to 2–3 simultaneous pilots by design.
Embedded Consulting Pilots
Consulting outcomes delivered using Novida’s internal analytical frameworks at standard consulting rates.
Co-Development Pilots
Working prototype access at preferential rates in exchange for structured feedback on data products in development.
Early Access Subscriptions
Recurring access to data products at early-partner pricing, with feedback sessions shaping product development.
Pilot Engagement Programme
Early access. Structured and limited.
Novida is developing a structured paid pilot programme providing select clients early access to proprietary analytical frameworks.
Limited to 2–3 simultaneous pilots by design.
Embedded Consulting Pilots
Consulting outcomes delivered using Novida’s internal analytical frameworks at standard consulting rates.
Co-Development Pilots
Working prototype access at preferential rates in exchange for structured feedback on data products in development.
Expert access throughout
Recurring access to data products at early-partner pricing, with feedback sessions shaping product development.