Start Clinical Trial Planning Early

One of the most common questions drug developers working on their preclinical testing ask is, “when do we begin planning our IND (or CTA)?”

The simplest answer is – it depends. Do you have the following?

  • Proof-of-concept scientific data
  • Early Pharmacokinetic information
  • Target Indications selected or prioritized for clinical trials
  • Evidence of GMP manufacture
  • Funding secured for clinical trials
  • Drug stability data
  • Nonclinical toxicology studies

Once you have decided to bring your therapeutic forward to clinical trials, it is then time to begin working on your IND/CTA and starting to plan your trial(s).

 

 

 

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EXPERTISE FROM


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Veristat's regulatory, statistical, medical and communications experts prepared 45+ INDs in 2020 alone.


Considerations During Clinical Trial Planning &  Design

    A full interdisciplinary team is ready to:

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Develop the clinical trial protocol including - 

  • Population
  • Choice of control group
  • Selection of starting dose
  • Duration
  • Safety monitoring
  • Outcome measures

 

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Regulatory Planning/Medical Writing

Statistical/Data Planning

  • Ensure that the clinical trial's statistical design will meet the intended objectives 
  • Evaluate potential of  implementing Adaptive Design approaches
  • Run clinical trial simulations
  • Perform predictive modeling

Medical/Clinical Planning

 

 

The Right Clinical Trial Planning Resources

With Veristat, you get the right resources to build a regulatory agency worthy clinical development plan to get your clinical trials to first patient in. When you work with Veristat, you get:

  • An agile focused strategy that will work​
  • Hit your timeline- minimal disruptions​
  • A plan aligned with your funding​
  • The right expertise at ​the right time (access to expertise when and where you need it) ​
  • A solid agency relationship to IND and beyond
  • Peace of mind – this is what Veristat does​


 

More Clinical Trial Planning Support

Learn more about our specific clinical trial conduct services to keep your trial on track.
  
Strategic Planning
  
Adaptive Designs
  
Regulatory Consulting
  
Regulatory Agency Meeting Support
  
Patient Recruitment
  
Data Management
  
Biostatistical Planning
  
Medical Writing

 

Let's talk. Get access to the right planning resources early. Contact Us Today!

LET'S TALK