Adoption of regulatory application improving patient safety & resulting in favorable clinical outcomes

Biopharma company building best practice regulatory application to create a seamless end to end practice and process supporting the clinical trials process. Needed to align all streams, parties, work and rollout for adoption by 10,000+ users in global locations and manufacturing sites. 

WHAT we did

  • Transitioned project team from agile development to an implementation path, revising governance, workstreams, core teams, initiative cadence,  establishing key timelines and outcomes. 

 

  • From planning to implementation, Karois brought together third party application developers, system integrators, database  and change management experts working with client digital and business leads to rollout the digital adoption.

 

  •  We achieved internal alignment of three functions spanning six or more specialized areas and reaching over ten thousand core user and tens of thousands more stakeholders; we set a plan in place for continuous technology and process development.

THE RESULTS

● Provided efficient oversight to improve clinical outcomes and patient safety

● Improved information delivery to provide relevant content for more users

● Aligned functional business processes for internal and external stakeholders