It all starts with a thought, I think.
Who knows where thoughts come from?
Why are some thoughts fleeting and why others change the world?
Consider this, you have travelled back in time.
An engineer points at a round thing.
From the engineer’s mouth you perceive two ancients sounds strung together, “Me. Do”.
With a deft transfer of energy from the engineer’s body, through their arm, and out a hand to gently initiate the rolling of the wood, mankind’s trajectory forks and the wheel rolls over your foot.
Sometimes thought germinates collaboratively.
Maybe the wheel was a group idea.
Maybe two, or three people were tasked with acquiring large round river stones for the town.
Would a small pod of people struggling with a large river stone, collectively iterate until they found the most efficient method to work together?
Could a community, astride each other, manifest the something so magnificent as the wheel simply by supporting each others? Is it ever, “Me. Do.”? Or is it always, “We. Do.”?
I speak technology.
I speak people.
Seasoned Global Clinical Operations (GCO) IT professional with > 20 years’ experience designing processes and building the technologies support all things data.
Decades spent learning how folks operate in GCO has allowed the continual honing of the skills required to successfully manage change via continual process improvements.
Enjoying a career-long learning experience where success requires me to be working closely, and holistically, with multitudes of disparate Stakeholders.
I speak IT.
I also speak Clinical, Quality, Regulatory, Study Start Up, Real-World-Data, Procurement, Data Governance, Medical Writing, Submissions, Operational Data Analysis, Health Authority Inspections, Learning, Manufacturing, Marketing, Vendor, Process, CRO, CTMS, eTMF, IQ, OQ, PQ, CFR, CRF, PHI, you get the picture.
Bringing common language across stakeholder communications leads to a more harmonious and efficient experience.
Steve jobs, Systems Thinking, and the ability to connect the dots.
Steve Jobs’ 2005 Stanford Commencement Address
“You can’t connect the dots looking forward; you can only connect them looking backwards…this approach has never let me down, and it has made all the difference in my life.”
The foundation of Steve Jobs incredible ability to connect the dots is built upon his Systems Thinking skills.
Systems thinking is a process through which one comprehends a system by examining the interactions and linkages that exist between the components of the system.
Systems Thinking provides methods to push beyond the immediate problems to see the underlying patterns, to fix issues or o implement holistic improvements.
Trained in Systems thinking by Jason Lim (Systems Thinking Guru), coupled with a curios disposition and decades of build experience, brings a particularly acute 3-D model of how systems inter-operate in the real-world.
This career-long, honed ability to break systems down into their discrete components - while re-imaging their configuration - provides extremely valuable oversight as programs goes from concept, through design, and into build, testing, deployment, and maintenance.
“Creativity is just connecting things.” – Steve Jobs
Stuff I’ve Built for Life Sciences
Thoughts That Have Become Things in Life Sciences That I Have Been Lucky Enough to Participate In
First to market — e-FAST (electronic-File-And-Study Tracker)
Automated conversion of paper CRFs and their supporting Clinical metadata into FDA Submission Compliant format.
Portfolio-level automation CRF image conversion to hyperlinked PDFs enabled cascading GCO efficiencies.
Prior to our solution reaching the market, the world's largest pharmaceutical companies, running the world's largest Phase IV clinical trials, paid their CROs to have a Clinical Trial Administrator (CTA) manually update CRF casebooks in their PDF compliant structure. This was laborious and costly. It was estimated that > 50% of the cost of processing CRFs was incurred from update made to existing CRF PDF Casebooks.
Pfizer's GCO realized an 80% reduction in CRF processing costs. Pfizer quickly ported over their Phase IV portfolio to our new solutions.
This provided Pfizer's GCO large scale savings across their Phase IV clinical trials portfolio while also providing meticulously organized data to the FDA.
Almost First to Market — ARCC — Audit-Ready-Compliant-Cloud
If you can’t beat your computer at chess, try kickboxing. — Anon.
ARCC is a 21CFR Part 11 compliant qualified Hosting in an Audit Ready Compliant Cloud Infrastructure for the Life Science Industry that takes complexity, cost and risk out of obtaining, deploying and managing a qualified and validated cloud solution that supports regulatory requirements.
Almost First to Market — RegDocs365
RegDocs365 offers a suite of solutions for regulated content and collaboration, specifically streamlined for life sciences. One of the first regulated cloud based, SaaS offerings for managing regulated documents and repositories as eTMF.
The Thought That Became a Thing that Scorched Kid’s Migraines...
Before the FDA approved Nurtec, and before Biohaven went public, there was a small group of thoughtful, committed citizens who thought that they could change the world and indeed, they did.
- Just a thought.
- A thought that became a company.
- A company that became a unicorn.
- A unicorn that became a biotech.
- A biotech that has put migraines on ropes.
I was introduced to Biohaven by Keith Parent, CEO of Court Square Group.
Biohaven was comprised of 7 people when Keith showed up in their orbit.
Keith had an early front row seat. Luckily, Keith asked me to pull up a chair, or rather a desk, and help out.
Back then, Biohaven was just an idea. A thought.
This is the story of how a thought became a thing...
It was a very beautiful and holistic thought.
A thought so well crafted, that when communicated from one individual to another that the lingering euphoria of the Aha! created an onramp for others to be included in the journey.
But this thought, like all thoughts, did not exist in a vacuum. A thought may seem to appears in our head, behind our eyes. But who knows where it actually resides?
Your head is connected to your body which has its own language which is communicating with the physical realm.
It is interesting that a thought springs from your mind-body so profound, so perfectly timed with the current inertia of the space-time continuum, that altering the course of humanity would be a likely? Probable? Viable?
The thought that ignited.
I wonder what the experience is like to be so knowledgeable about so many things, that correctly applying this lifetime of experience with innumerable disciplines, that once could manifest a multi-billion dollar operation?
What does it feel like to be carry that a badge of honor.
To enable a physician to write a script so that your kid no longer suffers from migraines is what was accomplished.
“Take this, Honey. No more migraines.”
BHVN Epilogue
To look back on a life and humbly submits that you were able to contribute at that level was s a gift.
My small portion of keeping the clinical data flowing so that the trials could be run, so that the data could be collected, analyzed, explained, and submitted, is an honor that I carry and cherish.
Keith’s an outside guy and had no compunction to become #8. Keith stayed on the outside and his software has been helping Biohaven grow from idea to a healing enterprise.
Keith’s software, RegDocs365, still runs and supports Biohaven in GCO, Medical Writing, eTMF, Submissions, Quality, and Learning. Hat’s off, Keith and all the folks at Biohaven - and thanks for the experience.
Biogen (GCO) Data Ambassador
Authored a analysis of Veeva, Medidata, goBalto, Komodo, WCG Clinical, and Optum.
Co-Authored the Program Charter.
Developed FAIR program reporting infrastructure, led the Business Case and Budget approval processes, managed relationships with IT, IT Quality, Procurement, R&D Compliance, and Data Analytics and Technology (DANTE).
Designed the Stage Gates approval strategy, led the vendor discovery workstream with a focus on the ability of vendors to meet the Program’s requirements.
Built a requirement gathering reporting tool to readily audit the progress of requirements gathering team.
Thoughts from the Field — Veeva, Medidata, Komodo Health, Oracle / goBalto, Optum, WCG, Databricks.
Where do they intersect?
- SSU
- County Feasibility
- Site Feasibility
- Site Selection
- Operational Reporting
- Real World Data
- Site Intelligence
- Contracts
- CTMS
- eTMF
- Budgets
- Study Project Management
What do Veeva, goBalto, Medidata, Komodo, Optum, Databricks, and WCG Clinical have in common? Reach out to me. I’d love to hear from you.
How To Capture Thought
How Learning is Remembering traveled to Connect the Dots
Socrates (469-399 B.C.) to Jobs (1955 - 2011 A.D.)
If Socrates was alive, would he concur with Jobs?
With all our new tech, we have access to so much more information.
We can connect the dots much faster than Socrates.
Less new information to process back then.
Does the advent of technology reaffirm what Socrates knew?
Has technology changed what the definitions of what we knew?
We have so many visual queues and the ability to ask and answer questions now success from cross-pollination of knowledge is exploding.