Case Study: How Altasciences Launched a Phase I Study 70% Faster Than the Industry Standard

Clinical trial start-up is a critical phase that carries many risks of delay, that can adversely impact the study timelines and budget. Altasciences was able to achieve an expedited project launch from the typical 12-week start-up process to just 3.5 weeks for a client by aligning our internal team on all objectives, engaging in open dialogue with the sponsor, and optimizing project management by assigning two project leads in two different time zones.

SAVING THE DAY WITH STRATEGY AND SPEED

In this case study, a sponsor approached Altasciences with an urgent need to complete a Phase I multiple ascending dose (MAD) study with a tight turnaround for a regulatory filing. The requirement was to shorten the usual 12-week study start-up process to under four weeks, which meant rapid coordination across critical steps like essential documentation, supply procurement, Institutional Review Board (IRB) approval, and participant recruitment and screening.

SPEEDY CLINICAL SOLUTIONS THROUGH OPTIMIZED PROJECT MANAGEMENT

To optimize project oversight, Altasciences employed a dual project management structure: a primary project manager on the East Coast, and another on the West Coast—specifically dedicated to Altasciences’ clinical research site in Los Angeles. This setup enabled nearly 12 hours of daily project management support to maximize efficiency and coverage across time zones.

STRATEGIC COMMUNICATION: THE KEY TO EFFICIENT CLINICAL TRIAL START-UP

Altasciences’ approach began with strong alignment across internal teams, and open communication with the sponsor. The assigned dedicated project managers quickly established a streamlined start-up plan, emphasizing open communication channels  and aligned expectations against feasibility.

By fostering a strong relationship with the sponsor, Altasciences ensured quick responses. They addressed issues in real-time, primarily through direct calls rather than email exchanges, to cultivate a dynamic and agile collaboration.

A structured meeting strategy that balanced internal planning and alignment with the sponsor was created by the primary project manager, and meetings were broken down into three  team discussions each week:

1. Internal Meeting: The project team intended this for internal discussions, allowing team members to collaboratively address issues and challenges, thus reducing the need for lengthy email exchanges.
    
2. Full Team Meeting: The meeting agendas, designed for all stakeholders, including the client, were specific and focused on specialized points for each functional group to address. This approach promoted active participation and removed vague agenda items.
    
3. Altasciences PM-Client PM Meeting: The primary PM and the sponsor PM held this meeting at the end of each week, intending it for one-on-one communication. It provided a forum to review the previous week and look ahead to the coming week, with the goal of confirming deliverables and reviewing risks to any critical-path items.

FOCUSED TIMELINE MANAGEMENT

The project manager strategically guided the team by splitting timelines and focusing on start-up through first subject first visit (FSFV), to achieve the sponsor’s KPI of “first dose” in under four weeks. This sharp focus on the early phase of the study allowed the team to meticulously review tasks and identify areas where time could be saved. Continual cross-functional collaboration meant that teams could complete start-up tasks in parallel. 

Regulatory document preparation and IRB approval occurred while teams generated study documents, acquired supplies, and built the database/eSource. This facilitated an early start on participant screening once IRB approval was granted. 

RISING TO THE CHALLENGE OF ACCELERATING STUDY START-UP TIMELINES 

Through optimized project coordination, direct team leader-sponsor communication, and focused timeline management, Altasciences successfully reduced the study start-up timeline to 3.5 weeks, achieving first subject dosing ahead of schedule. In the end, Altasciences’ integrated and holistic approach reduced the client’s clinical trial start-up by 70%!

Ready to accelerate your drug development timeline? Contact Altasciences to discover how our expert project management and innovative solutions can reduce your time to market.

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^12/09/2024