Challenge: In an economic downturn, small biotech companies often depend on clinical milestones in order to maximize shareholder value and drive market direction. This means that their CRO must completely understand and be aligned with the sponsor’s corporate objectives. Meeting an aggressive timeline on a challenging protocol is a significant driver of share price and market perception.
Results: ARG successfully started a Phase II intradialytic hypotension trial and enrolled the first patient within 6 weeks of contract signature. Using TrialVista®, ARG’s proprietary CTMS, the implementation of all study start–up activities, from investigator recruitment to investigator product supply, was streamlined — and, based on its advanced approach to project management, several steps were significantly reduced or even eliminated.
ARG was able to simultaneously get all the trial materials developed, finalize CRF design and collaborate with qualified investigators to ensure FPI (first patient in) deadlines were achieved ahead of schedule.
ARG has been ahead of every study metric since the FPI deadline and completed enrollment on this 15 center, 75 patient trial on time and on budget.
Lessons Learned: It is critical that your CRO understands the corporate goals of its sponsors and adjusts their resources to meet the demands of the study. Aggressive timelines are some times unrealistic, but at ARG we thoroughly evaluate each component, apply the best and correct amount of resources needed to meet or exceed our client’s needs.
By utilizing TrialVista®, and ARG’s experienced clinical management team, sponsors are ensured of several things:
Total Team Involvement
Precise Monitoring of Key Trial Parameters
Clinical Operations Manager & Product Development: “ARG was able to go from contract to enrolling the first patient in an incredibly short period of time. We are extremely pleased to be working with them on this trial and are excited about being able to utilize TrialVista® throughout this study”