How We Do It

|How We Do It
How We Do It 2017-06-30T20:00:10+00:00
What We Do

By adapting responsively to change, we minimize your clinical trial risk and drive quality outcomes.

Change is inevitable throughout clinical development. Working collaboratively and strategically responding to change as it arises allows us to explore multiple pathways to market. Engaging in a true partnership enhances operational success and your ability to get to market as efficiently and quickly as possible.

Our flexibility allows us to staff projects with industry experts in response to your specific trial needs. We can tailor workflows and processes to consistently adapt to the dynamic changes inherent in clinical research.

How do you benefit from a flexible workflow?

  • Rapid EDC build times that beat industry standards
  • 100% timeline adherence rate
  • Siloes avoided through cross-training of all team members across studies
  • Custom-designed services for individual rescue studies that consistently optimize time, cost, and quality
We act as an extension of your team, relaying regular status updates as well as providing evidence-based recommendations to keep projects on track. We proactively initiate transparent, collaborative communication throughout the trial lifecycle.

How do you benefit from transparent communications?

  • Team members are empowered to make decisions based on your study’s best interest
  • Proactively identification and communication of issues and solutions
  • Intensive study-specific training, cross-functional communication, and superior study team education ensure we always keep your end goal in mind
We provide a thoughtful and purposeful approach to every project by integrating data-centric processes with clinical expertise. Our experts lead teams designed with a focus on key clinical capabilities and specialized services that add intrinsic value along the way.

How do you benefit from strategic focus?

  • Case-by-case implementation of data-centric and responsibility-centric methodologies
  • Integrated expertise provides a high level of strategy not available from larger CROs
  • Culture of success facilitated by abundant communication and avoidance of silos built into each study
  • Risk-based monitoring (RBM) and data-driven monitoring promote cost effective savings as opposed to the industry-standard use of interval-based monitoring
Our leaders have extensive experience from all aspects of the global drug development industry. We apply this diverse foundation of knowledge to strategically plan your project, identifying and mitigating potential risks to enable informed decision-making and project success.

How do you benefit from our clinical leadership and expertise?

  • Executive member assigned to each client account to provide client prioritization, partnership, and corporate accountability
  • Application of corporate knowledge and guidance from regulatory submissions ensure our commitment to full project lifecycles
  • Thorough medical review from on-staff MD for all projects ensure scientific and operational alignment to delivery goals

As an ISO 9001:2015 quality-certified organization, we consider quality to be a service provided to all our clients. We build quality into our workflow and processes to help you meet your end goals, including optimized data, patient safety, reduced time-to-market and operational savings.

How do you benefit from our quality certification?

  • ISO 9001:2015-certified processes and hundreds of SOPs ensure adherence to industry-quality standards
  • 80% repeat business rate demonstrates a deep trust by our clients in our abilities
  • Efficient implementation of double-programming minimize study errors

“We foster true collaborative partnerships with our clients. Honest and transparent communication has allowed us to best serve the needs of our clients and, ultimately, patients. That’s an exciting opportunity, and challenges me to be my best every day.”—Mike Keens, Chief Commercial Officer

“We’re passionate about providing our clients with the highest-quality experience for every project we take on. We’re committed to working side-by-side with our clients as partners, using that personal investment to advance medicine and treatments to improve human lives.”—Chrissy Fleming, PhD, President and Chief Scientific Officer, Clinical Research Services

Want to minimize your clinical trial risk and drive quality outcomes?

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