Programs stall. Resources get pulled, KPIs get missed, protocols turn out to be unworkable in the real world, and every day the program stays stuck, the cost keeps growing. It's optimal to maintain consistent project teams throughout clinical development, but when a program veers off course, the stakes are too high to wait and see.
Veristat has a proven track record of getting clinical development programs back on track. We diagnose the root cause using the data your program has already generated, evaluate what's genuinely at stake in waiting, and move quickly to intervene, whether that means taking over a single service or the entire program.
Get Your Clinical Trial or Regulatory Submission Program Back on Track
How Clinical Trials Get Stuck
Resources (subject matter/medical knowledge experts) are lacking or get pulled
Internal teams, CROs, or partners fail to meet KPIs, milestones, or critical deadlines
Project teams miscommunicate or misunderstand expectations
Protocols are poorly designed, misunderstood, or don't accommodate real-life implementation
Sites, CROs, labs, and technology vendors are not trained properly
A regulatory agency performs an audit and you must fix the audit findings, or issues a Clinical Hold or Refusal to File.
Why Veristat
Overcoming Clinical Trial Challenges
We address the roadblocks that stall programs most often, easing patient recruitment and retention by reducing travel burden, removing geographic barriers to patient eligibility, offering a flexible and fully integrated hybrid site model customized to comfort levels, and helping sponsors navigate ongoing disruptions like those introduced by COVID-19.
01
DIAGNOSE
Determine the root cause(s) of your key problems or issues.
02
ASSESS
Evaluate the risks of not fixing key problems now.
03
TAKE OVER
Take over any or all services to support the program.
04
TRANSITION
Prepare and execute a transition timeline.
PROOF & RESOURCES
Learn More with These Resources
Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works
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Days Instead of Weeks: What It Actually Takes to Close the DBL-to-TLF Gap
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The Psychedelic Setback: What MDMA Rejection Taught Drug Developers
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Let's Talk. Connect with a Rescue Trials Expert Today.
We know there are always unknown challenges when bringing a novel therapeutic to market, so we've assembled an extraordinary team of scientific-minded experts who have mastered the complexities of therapeutic development, enabling sponsors to succeed in extending and saving lives.
A clinical trial rescue program is a targeted engagement to get a stalled or off-track clinical trial or regulatory submission program moving again. Veristat diagnoses the root cause of the delay, evaluates the risk of continued inaction, and takes over any or all services needed to bring the program back on schedule.
Common warning signs include missed KPIs or milestones, a regulatory agency disagreeing with your protocol or development plan, patient recruitment or site activation falling behind schedule, and quality issues or missed deadlines with study data or documentation.
Veristat follows a four-step process, determining root cause, evaluating the risk of delay, taking over needed services, and executing a transition timeline, designed to move quickly given how costly continued delays can be.
Both. Veristat can take over any or all services needed to support a stalled program, from a single function to full program management, depending on where the breakdown occurred.
