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Clinical Trial Success Case Study

Overview

As a critical component in the success of any clinical trial, Study Start Up sets the foundation for efficient and high-quality project execution. Ensuring a smooth and rapid start-up phase is essential to overcoming challenges in site activation, recruitment strategies, and hitting established timelines.

Pintail Solutions’ clinical operations experts deliver best practice solutions to overcome critical challenges and accelerate the study start-up phase of clinical trials.

In this case study, we'll describe in detail how we help our clients achieve rapid study start-up 35% faster than benchmark data, resulting in increased cost savings and positioning us as the preferred partner for both sponsors and sites.

Building strong relationships with each site allowed us to act as their site activation partner while they navigated uncharted waters at record speed; leading this project toward unprecedented success.

Below is a Modified Transcript.

Project Background

Determined to reduce cost and time associated with clinical trials, a nonprofit dedicated to Alzheimer’s research sought out Pintail Solutions’ expertise to expedite a clinical trial study start up. Pintail Solutions deployed their best practices and extensive hands-on approach coupled with change management expertise to ensure quick study launch times without compromising quality.

Challenges

In the discovery phase, Pintail Solutions identified several challenges that would hinder timely site activation and quickly implemented changes to put the study back on track.

Challenge 1: Navigating Intricate Clinical Trial Site Activation

When working with multiple parties for clinical trial site activation, processes can quickly become overcomplicated, creating a lack of clarity which can impede success. This is why our team partners with sponsors and CROs right from the start to determine roles and responsibilities, and to forge ahead towards an optimal vision for rapid study start-up. Establishing clear and transparent communication with all parties is key in achieving success.

Challenge 2: Trial Study Start Up Processes Were Poorly Defined

Another challenge Pintail Solutions identified was that the trial study start-up processes were poorly defined and undocumented.

Pintail Solutions’ approach to clinical trial site activation is collaborative and supportive. We provide a personal service for each partner with an extensive Study Start-Up toolkit, so that the process can be defined and executed efficiently, without interruption.

We use custom designed process maps and best practice templates that help streamline site operations during this period, applying Lean Six Sigma principles to ensure improvements happen quickly. In the event of any challenges during set-up, we are prepared to partner with all involved parties to improve timelines and ensure project success.

Results: Reduced time to activate sites by 35%*

Pintail Solutions' concise execution made all the difference for the client's rapid study clinical trial start up. Our innovative approach reduced time to activate study sites by 35% *over benchmark data, resulting in an accelerated timeline, project cost savings, and ultimate site activation success!

Conclusion

If you take away one thing from this case study, let it be this. No matter how daunting your projects’ challenges may seem, even crippling at times, Pintail Solutions can guide you onto the path of project success.

Our experts are trained to organize the chaos and put sustainable business plans and practices in place.

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Pintail Solutions is a niche management advisory firm focused on enabling overall project and portfolio delivery, developing and deploying new business strategies, and delivering construction projects across life science organizations.

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