Jaani Gandhi
FRACTIONAL HEAD OF SCIENTIFIC AFFAIRS & CLINICAL EVIDENCE
PRINCIPAL CONSULTANT
THE FOUNDER
Meet your strategist and partner
I've spent my career helping life science and healthtech companies turn raw data into meaningful clinical reviews that can be leveraged across a variety of functions - reducing costs and workload associated with appraising it. Along the way, I've had the privilege of collaborating with organizations with annual revenue from $10M to $30B, and growing.
As a Fractional Head of Scientific Affairs and Clinical Evidence, I partner with healthtech founders to build the strategy to grow a lean and scalable organization.
NOW
Empire HealthTech — Fractional Scientific Affairs advisor. regulatory documentation, and scientific communication specialist
INDUSTRY
Medical Device, Pharma, and Wellness Manufacturing — scientific affairs with a focus on contract strategy engagements in clinical evidence. regulatory writing, medical writing, post-market surveillance, project management, and protocol development
RESEARCH
Pre-clinical & Clinical Research — drug pathway modeling, patient data analysis, model development
The same problem, every single time.
Before founding Empire HealthTech, Jaani had been neck deep in the industry for years - working with fast-growing medical device, healthtech, and wellness organizations. They had momentum, strong products, and real demand.
She kept seeing the same thing: companies spent thousands of dollars re-purchasing the same content packaged differently for different purposes.
Literature and clinical data reviews for regulatory, marketing, sales, and R&D, each presented to answer specific questions.
The work was redundant, the data was redundant.
The cost? High, and climbing with each whitepaper, each marketing claim, and each regulatory body response.
The redundancy was shocking. The cost associated with each deliverable was ever-increasing, all because there wasn't a cohesive system in place.
What's getting in the way of the science?
YOUR EVIDENCE IS SCATTERED
Literature reviews, complaint data, post-market study results — all in different places, owned by different teams, never connected into a coherent picture.
YOUR SALES TEAM CAN'T ANSWER THE REAL SCIENTIFIC QUESTIONS
The clinical evidence exists. But it never makes it into a format your commercial team can actually use in front of a hospital procurement lead or an investor.
YOUR DOCUMENTATION IS REACTIVE VS. STRATEGIC
You update when the Notified Body asks. You scramble before an audit. Your asking your engineers to answer clinician questions. There's no system, no ongoing monitoring, no early warning when something changes in the evidence landscape.
TRIED AND TESTED STRATEGIES
Your evidence challenges? Solved.
I've seen the same struggles across dozens of high-performing teams and brands. Pouring thousands into clinical evidence without organization, clarity, or systems in place,
The truth? These challenges are solvable. I've worked with founders, department heads, and Fortune 500 companies - turning clinical evidence into a tool leveraged across multiple functions - clinical affairs, regulatory affairs, R&D, marketing, sales, and more. I bring the strategy - custom built to your organization - to every engagement.
Here's what the process looks like:
A Gap Assessment
No more scouring for dead shared drive links, original files, or old emails - long gone due to the org. policy. Jaani identifies the overlap and gaps in your current evidence - learning about what your goals and requirements are.
An Evidence System That Works
Your evidence becomes meaningful. Jaani structures everything you have to deliver a live handbook that can be leveraged throughout the organization.
And a partner that grows with you.
Instead of running after new data every time the team needs something, you'll have a live system, updated often, designed to carry your brand through every stage of growth.
Clarity in the Data
Forget about a report that's hundreds of pages long. Jaani will show you what actually moves the needle, and how to use the data to make confident branding and growth decisions.
Two Ways to Work Together
Project-Based
FOR ORGANIZATIONS THAT NEED HELP... YESTERDAY
Total ownership of handed off projects
Synthesis of clinical data in the format you're looking for (whitepapers, sales copy, marketing claims, regulatory responses, and more)
Async email/Teams/Slack support
Clear action steps for sustaining
Fractional
FOR ORGANIZATIONS READY FOR HANDS-ON LEADERSHIP
Full ownership of the scientific affairs function - including clinical evidence, collaboration with sales and regulatory for responses and sustaining
Weekly meetings with your team
Hands-on support to run scientific affairs
Regular State of Evidence updates