CRO AmplifyBio Accelerates Trial Success with Digital CSV


AmplifyBio, a leading contract research organization (CRO) spun out of Battelle, leverages cutting-edge technologies to drive efficiencies and differentiate its wide breadth of services. This digital-first mindset helps them better serve sponsors and study partners and gain a competitive edge.

The company recently deployed the ValGenesis validation lifecycle management system (VLMS) to validate equipment and computer systems. The user base has grown significantly in just a few months. Currently, there are 27 in-flight initiatives across three sites, spanning preclinical research to product development and manufacturing. Here's a glimpse into their remarkable journey.

(You can read the full case study here.)

Challenges with Paper

Before implementing ValGenesis, AmplifyBio used a paper-based system for validating equipment and computer systems that involved many steps and administrative tasks. Capturing objective evidence was particularly tedious. Other pain points included: 

  • Data entry errors and discrepancies
  • Approval delays and poor collaboration with test scripts
  • Wasted resources combatting subjectivity and missing standardization

"We were looking for a workflow-driven solution that would provide the standardization and digital handholding our users needed at every step of the validation process, from system evaluation to archival, said Quality IT Systems Analyst Rebekkah Hesson, who served as AmplifyBio's implementation champion and primary subject matter expert on the project. "ValGenesis is like TurboTax for validation!"

A Positive Implementation Experience 

AmplifyBio went live with ValGenesis in 2023. While the actual implementation took only eight weeks, the company was forced to pause twice: once to redirect resources to tackle growth spurts and business priorities and a second time to refresh their existing CSV process rather than automate what had become flawed procedures.

Hesson showered accolades on ValGenesis Project Manager Sandeep Lakshmanan and Senior Business Analyst Eliot Davidson for their patience and professionalism. Davidson's exceptional performance earned him the prestigious On the Spot Award, a highly coveted recognition traditionally reserved for AmplifyBio employees who consistently surpass expectations.

“The ValGenesis Professional Services Team was as patient as could be," Hesson said. "The number of starts and stops we had would have frustrated anyone, but they were able to jump right back into the project as if no time had passed ― and come up with innovative solutions to every configuration challenge we threw at them."

Unlocking More Time in the Day with Enhanced Processes

Hesson immediately observed significant improvements in processes and a noticeable boost in efficiency shortly after implementing ValGenesis. The positive impacts were undeniable and included:

  • A 75% increase in test evidence-gathering efficiency
  • A 50% reduction in document approval tasks 
  • Improved remote team collaboration 
  • Fewer audit findings 
  • A more streamlined process for audit submissions 

Expanding Usage into Other Departments 

ValGenesis continues to help AmplifyBio reduce the administrative time and busy work that comes with validation, allowing them to focus on tasks that impact the business as they branch out into new therapeutic areas. Users appreciate the efficiency gains, and stakeholders are keen to expand usage into other departments, such as CQV and facilities/site engineering, as part of the company’s strategy to modernize its technology landscape.

Read the full case study. Learn more about AmplifyBio.

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.