Solutions

Rescue from Clinical Trial Challenges

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 of common clinical trial challenges 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 Clinical Trial Challenges

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

  • Improving patient recruitment and retention for trials by reducing the patient burden of travel and time going to physical sites
  • Finding the right patients by removing geographic barriers to patient eligibility
  • Offering a flexible and fully integrated hybrid site model customized to the comfort levels of the patients, sites, sponsors, etc.
  • Overcoming COVID-19 restrictions and restoring continuity of new and ongoing clinical trials regardless of future restrictions

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 clinical trial challenges, such as:

Veristat_icon_rare disease

Trial Planning

Regulatory Agency (e.g. FDA, EMA, etc) doesn't concur with your protocol or development plan

Veristat_icon_start-up-1

Study Start-Up

Patient recruitment or site activation falls behind

Veristat_icon_implementation

Trial Execution

Quality issues or missed deadline with clinical trial data, study documentation, or deliverables.

Veristat_icon_regulatory approval

Regulatory Concerns

A Regulatory Agency performs an audit and you must fix the audit findings or issues a Clinical Hold or Refusal to File

Considering bringing on an external team to rescue parts or all of your clinical development program?

LET'S TALK

Learn More with These Resources

Fact Sheet

Regulatory Publishing to Support Successful eCTD Submissions

Case Study

The Power of Publishing for an Efficient NDA Submission ...

Case Study

Supporting a Sponsor from SPA Rejection to BLA Submission