Clinical Trial Rescue

Getting Your Clinical Trial or Regulatory Submission Program Unstuck

No sponsor launches its clinical development program with the intention of adding or switching partners along the way. Clearly, it is much more efficient and cost-effective to have the same project team throughout. However, sometimes the progress on a program gets stuck or is going in the wrong direction. When that happens, we can help.


At Veristat we have a proven track record of getting clinical development programs back on track, we know the stakes are high and you can’t afford to slow down. Let us help you move forward.

How A Clinical Trial Gets Stuck 

Clinical programs get stuck all the time, and many times, there is no one to blame. Sometimes the best intentions and decisions do not work out as planned. A few examples include:

  • Resources (subject matter/medical knowledge experts) are lacking or get pulled, and the work can no longer be done in-house
  • Internal teams, CROs, or partners fail to meet KPIs, milestones, or critical deadlines
  • Project teams (including internal departments/vendors) miscommunicate or misunderstand expectations 
  • Protocols are poorly designed, misunderstood, or don’t accommodate real-life implementation situations
  •  Sites, CROs, Labs, technology vendors, etc. are not trained properly on execution nuances
Clinical Trial Rescue

Advancing Your Study Is Our Mission

Overcoming Current Challenges

These are the steps to help you determine if your program needs a rescue:

  • Identify all the key problems or issues
  • Develop a list of interventions most likely to have an impact
  • Review all possible interventions, rank and rate them in terms of their effectiveness, and then prioritize
  • Consider adding or replacing current resources on the project

Getting UnStuck

At Veristat, we understand that getting stuck will not keep your program accelerating forward. That is why we have a team of scientific-minded subject matter experts to get your programs unstuck.

Here is the plan of how we help you:
  • Determine the root cause(s) of your key problems or issues
  • Evaluate the risks of not fixing key problems now
  • Take over any or all services to support the program and get it back on track
  • Prepare and execute a transition timeline

Reasons To Consider Help

It is time to consider help when you run into the following challenges, such as:  

         clinical trial planning rescue

 

Trial Planning

  • Regulatory Agency (e.g.  FDA, EMA, etc) doesn’t concur with your protocol or development plan
clinical trial study start up rescue

 

Study Start-Up

  • Patient recruitment falls behind 
  • Site activation delays

clinical trial execution rescue

 
 Trial Execution 
  • Quality issues with clinical trial data quality, study documentation, or deliverables
  • KPIs or project milestones get missed
Regulatory affairs rescue Regulatory Concerns
  • A Regulatory Agency performs audit and you must fix the audit findings
  • FDA issues a Clinical Hold or Refusal to File

These are simply a few of many reasons to consider bringing on an external team to rescue parts or all of your clinical development program.

Learn More with These Resources

Case Study
Overcoming an NDA Refusal To File

Learn how the right biostatistical experts performed a quality review of the clinical data for an NDA that received a Refusal-to-File from the FDA.
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Case Study
Keeping Up with an Over-Performing Site Case Study

Find out how Veristat was able to expertly rescue the site management and monitoring activities for a  sponsor seven months into patient enrollment at the ...

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Case Study
Rescue Patient Recruitment for Lagging Trial

Patient recruitment delays are common challenges in clinical trials that can lead to costly delays. In fact, nearly 80 percent of patient recruitment timelines in ...

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