“Galen FP Solutions has developed a fully integrated, comprehensive clinical trial planning and execution solution that is exactly what a CFO, as well as Operations, would want to see and understand.
Successful execution of a trial requires understanding complex relationships, interdependencies, looking at things from all angles and around corners, to ensure the trial is delivered on time and on budget, with quality. I applaud the robust set of analytics, including cash flow/cost analysis, that the tool provides.
This level of operational AND financial controls for clinical trials is unmatched. It’s a fabulous tool that I would recommend without hesitation.”
Alison A. Cornell, former Chief Financial Officer at Covance, one of the world’s largest global CROs
Principal architect of the Trusted Process™, the metrics-driven methodology Syneos Health employs to consistently deliver actionable information to their customers – on time and on budget. As such, Jeff oversaw the development, deployment and use of the Trusted Process™ methodology by all Syneos project teams.
“Clinical trials are extremely challenging to manage, in part, due to the high number of variables, dependencies and assumptions involved. Arguably, assumptions around Site Activation, Patient Enrollment and Patient Discontinuations are the most critical to get right and, if under or overestimated, will play havoc with your timelines and ability to deliver on down-stream commitments such as Interim Analyses and DBL.
Dr. Galen and his team have developed a trial planning and oversight system to both “pressure test” these key assumptions before the study begins as well as to monitor them during trial execution, enabling you to make adjustments “in flight” ensuring that your study will proceed as planned.
Frankly, I can’t imagine conducting a clinical trial in the future without the benefit of this system to validate these key assumptions and ensure transparency and accountability during trial execution.”
Jeff Kueffer, Former Executive Vice President, Global Operations Management, Syneos Health
“Over the course of my 25-year career, I oversaw or led numerous, business-critical global development programs. Trial footprints spanned from 1 site in 1 country to over 1000 sites, in over 50 countries across the globe.
Each site and each country had its own nuances that impacted timelines, costs, and resourcing. This made clinical trial design, execution, and delivery complicated and challenging.
Our inability to predict trial timelines and costs, and how to best deploy our most precious resource – our people – impedes our ability to deliver novel medicines for unmet medical needs.
Galen FP Solutions provides a simple, scalable “air traffic control-like” solution to forecast, monitor, and predict timelines and the interconnected flow of patients, data, and work. This will set your organization up for operational success.
I will be using their services when I go into the clinic.”
Dr. Scott Wasserman, Chief Executive Officer, Latigo Biotherapeutics
“In my thirty-year career in Pharma, I led large global clinical development teams to deliver results for hundreds of clinical trials.
Despite all the data collected and tracked, it was always an enormous challenge to predict when trial data would be available for submission to regulatory agencies.
Galen F P Solutions has developed a fully integrated trial planning and oversight system that captures all key process interactions from protocol development to data analysis, and accurately assesses submission timelines in real time as conditions change.
This system meets a huge unmet industry need. If you are planning and executing clinical trials, you need to use it.”
Paul Bunch, PhD, Managing Director, Beacon Rock Consulting Former Chief Operating Officer, inVentiv Health Clinical
“To say that clinical trials are complex is an understatement. I have spent a career trying to deliver results in pharmaceutical R&D and have struggled to manage the thousands of deliverables across trial conduct over the years.
However, it’s not until you step away and come at the problem with some perspective that you understand how best to direct your resources and energies.
This is where Steve has nailed it. A common sense solution that is easy and flexible for project managers.
The best project managers are constantly looking forward yet rarely have simple tools to provide them insights. Well those days are over as Steve and his team have that solution to put into your hands that can help iterate that forward look and provide real time options for the critical path of EVERY pharmaceutical development program.”
Senior PM Leader, Top 5 Global Pharma
“I’ve led PM groups in both pharma and CROs and managing a clinical study is one of the most complex projects you can have.
Predicting a study is hard and yet knowing when the data readout will occur is the ultimate question for management.
I love the approach that Galen FP Solutions has taken – – applying engineering principles to known data sets that simply show where the study is going and predicting impacts.
Having seen the seeds of this product years ago I knew that it could impact study management.
And seeing the results now is impressive. I wish I’d had tools like this during my career.”
Russell Boyd, PhD, Head of Strategy Implementation & Business Transformation, AstraZeneca
Galen FP Solutions Commitments
Working with us is easy and we make the following commitments upfront:
• You will not need to change your clinical technology stack • You will not need to add data analytics personnel or tools