August 7, 2023 · 4 min read
Bringing Klarite through process optimization and needs analysis
Updated: January 17, 2024
Bringing Klarite through process optimization and needs analysis
Updated: January 17, 2024
“Our company had just merged, and the operating team were finding it difficult to define the big picture process that would integrate both technology and new LEAN ways of working. Having experience in these areas, Angela began to organize and lead our team. She began by first listening and understanding each nuance and need and then thoughtfully integrated each into an overall approach. Along the way Angela built trust in our team by documenting and pursuing solutions for long-lingering problems. Angela put her heart, time and soul into this endeavor and met lofty goals set by our leadership team”
– Operational Excellence Site Activation Team Member
– Operational Excellence Site Activation Team Member
A Top 10 Global Clinical Research Organization (CRO) that had recently merged, wanted to establish a new operating model and approach for study start up, with the goal of decreasing median cycle time and integrating new innovations in site selection and contracting.
As with any acquisition or merger there are differences in cultures and approaches that have often been built over years and decades. An attempt to document this new end to end process had been attempted and had gained little traction and so a new expedited goal of just 6 weeks was set. This limited collaboration and change management and is a good example of a lesson learned in setting realistic and aligned expectations.
Bringing Klarite to the Complex: Connection, Prioritization and Optimization
Clear and Successful Outcomes
As with any acquisition or merger there are differences in cultures and approaches that have often been built over years and decades. An attempt to document this new end to end process had been attempted and had gained little traction and so a new expedited goal of just 6 weeks was set. This limited collaboration and change management and is a good example of a lesson learned in setting realistic and aligned expectations.
Bringing Klarite to the Complex: Connection, Prioritization and Optimization
- Trust is a central component of all programs and so Angela immediately engaged and focused on getting to know the vast and siloed global organization. Due to the recent merger, teams were very slow to trust and due to the global nature, it was difficult to establish strong and trusting partnerships. Slowly but surely, key stakeholders began to engage, leading to gaps and issues being uncovered and a core team of representatives from each functional area developed. Through this, the team began to highlight goals, themes and opportunities for change.
- As there were a number of change engagements throughout the organization, there was significant competition for time. Meetings were therefore inconsistent and lacked full executive leadership support and collaboration. Due to the tight timelines, this led to work often being completed outside of normal working hours. Burn out was therefore being consistently monitored and timelines and goals were prioritized and adapted when required.
- Before moving to future, it is important to capture and document current state and so Angela connected with each functional area to establish an overall map of current state processes, highlighting what worked well and where we could increase efficiencies by either integrating new technologies or more LEAN ways of working. Through this we identified organizational needs/gaps and initiated a parallel path that worked on prioritizing and mitigating these.
- A final onsite meeting brought connection across the large and matrixed organization, who were together for the first time. This allowed the group hands on collaboration and an open space to see the bigger picture and make changes before finalization.
- The main challenge to any change is making it stick and so each functional lead that finalized the approach was part of the final presentation and had established a change agent network. This network had brought feedback and insights to the initial process and would continue to optimize through an established regular cadence. As with any two-way dialogue each change agent would also understand the progress that is being made to solve what matters most to them and their teams, continuing and enhancing trust.
Clear and Successful Outcomes
- Created the first end to end process that integrated new technologies for the Study Start Up organization.
- Eliminated 83% of siloed process steps.
- Decreased median cycle time.
- Created initial leading indicators from metadata, derived across several technologies that showed progress towards our goal. KPIs included measures of process and technology utilization, resource allocation, Study-site contracting timing, number of patients by site and geography, longitudinal patient loyalty, first patient in, time to risk resolution and last patient out.
- Created a phased digital transformation plan that integrated all current R&D tools and solutions resulting in an automated approach, streamlining service delivery.
- Created significant productivity efficiencies by eliminating significant hand off, laborious and costly meetings and manual work was replaced with automation and technology.
- Created the foundation of contract life-cycle management needs.
- Optimized site selection processes, being able to better understand the value and integration of each site.
- Lessons Learned that helped with future endeavors.