Clinical Trial Simulation

& Control

Predict data flow as well as enrollment

Quickly reposition resources

Save time and money

Control Your Trial™


Clinical Trial Simulation

& Control

Predict data flow as well as enrollment

Quickly reposition resources

Save time and money

Control Your Trial™

Clinical Trial Simulation & Control

Predict data flow as well as enrollment

Quickly reposition resources

Save time and money

Control Your Trial™

You are spending millions of dollars to run your trial, but whether Clinical Operations is in-house or CRO:

Clinical trial planning is unrealistic

Clinical trial execution lacks transparency

Your clean data delivery date is unknown

Galen FP Solutions solves these problems

Hear What Industry Leaders Have to Say:

Jeff Kueffer

Former Executive Vice President, Global Operations Management, Syneos Health

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.”

Dr. Scott Wasserman

Chief Executive Officer, Latigo Biotherapeutics

Former VP, Global Development, Therapeutic Area Head (Bone, Cardiovascular, Metabolic, and Neuroscience) and Head, Development Design Center, Amgen

“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.

“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.”

Paul Bunch, PhD

Managing Director, Beacon Rock Consulting

Former Chief Operating Officer, inVentiv Health Clinical

“Galen FP 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.

“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.”

Senior PM Leader

Top 5 Global Pharma

“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.

This is where Steve has nailed it. A common sense solution that is easy and flexible for project managers.

“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.”

Russell Boyd, PhD

Head of Strategy Implementation & Business Transformation, AstraZeneca

“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.

“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.”

Hear What Industry Leaders Have to Say:

Jeff Kueffer

Former Executive Vice President, Global Operations Management, Syneos Health

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.”

Dr. Scott Wasserman

Chief Executive Officer, Latigo Biotherapeutics

Former VP, Global Development, Therapeutic Area Head (Bone, Cardiovascular, Metabolic, and Neuroscience) and Head, Development Design Center, Amgen

“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.

“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.”

Paul Bunch, PhD

Managing Director, Beacon Rock Consulting

Former Chief Operating Officer, inVentiv Health Clinical

“Galen FP 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.

“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.”

Russell Boyd, PhD

Head of Strategy Implementation & Business Transformation, AstraZeneca

“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.

“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.”

Senior PM Leader

Top 5 Global Pharma

“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.

This is where Steve has nailed it. A common sense solution that is easy and flexible for project managers.

“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.”

Take control of your trial via realistic trial simulation and rigorous clinical operations oversight securing your clean data set in a predictable and cost-effective way.

Take control of your trial via realistic trial simulation and rigorous clinical operations oversight securing your clean data set in a predictable and cost-effective way.

Take control of your trial via realistic trial simulation and rigorous clinical operations oversight securing your clean data set in a predictable and cost-effective way.

Galen FP Solutions Process

Build a comprehensive realistic FirstPrin™ Trial Flight Plan for your trial that includes:

  • Site Selection
  • Site Activation
  • Patient Screening
  • Patient Enrollment
  • Patient Visits
  • eCRF Pages
  • Patient Discontinuations
  • Unscheduled Visits
  • Database Lock
  • Clinical Study Report

Oversee trial execution from the FirstPrin™ Trial Control Tower

  • Spot deviations from your FirstPrin™ Trial Flight Plan and quickly course correct
  • Update your FirstPrin™ Trial Flight Plan when the “real world” happens

Predict data flow as well as enrollment

Quickly reposition resources

Save time and money

Galen FP Solutions Services

How to Begin with Galen FP Solutions

  1. Design and Review Your Free FirstPrin™ Trial Flight Plan:
    • See how operational changes impact all key process outputs and milestone timing
    • Get insight into how resource requirements and spend change as process outputs shift
  2. Explore the FirstPrin™ Control Tower‘s Powerful Oversight Capability:
    • See the unparalleled visibility you can have at the process, country, region and trial level during trial execution
  3. Work with Us on Your Next Trial:
    • Design your FirstPrin™ Trial Flight Plan and we will translate those specifications into clear process-specific and country-specific targets
    • Ingest data during trial execution, overlay those data onto your FirstPrin™ Trial Flight Plan, spot deviations quickly and course correct
    • Always know when you will get your data

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