Solutions

Clinical Trial Planning

Navigating the transition from lab to clinic requires an interdisciplinary team of scientific experts.

Comprehensive clinical trial planning is essential for transitioning the development of a medical therapy into clinical testing. A cohesive plan will maximize efficiency and minimize risks in gathering the necessary clinical data to ensure the safety and efficacy of the therapy. The planning process is highly complex, unique, and requires close collaboration between an interdisciplinary team of regulatory, clinical, medical, statistical, safety, and scientific experts.

We understand that NOT building the right clinical development plan can be catastrophic to you, your business, and your therapeutic. To give you an advantage Veristat has assembled a team of scientific-minded experts that is adept at strategy and execution.

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).

 



 

IND and CTA preparation, regulatory publishing and medical writing
165+ INDs/CTAs have been supported over the last 5 years by Veristat's regulatory, statistical, medical, and communications

Considerations During Clinical Trial Planning &  Design

A full interdisciplinary team is ready to 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

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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

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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​

Get access to the right planning resources - 
contact us today.

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