Clinical Trial Planning

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).

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

Regulatory Planning/Medical Writing Develop the regulatory strategy and submission plan to support both US and global registrations Explore the possibility of pursuing expedited or alternate regulatory pathways for faster approval, and writing the corresponding applications Schedule and Prepare for Interact/Pre-IND meetings with FDA	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 Begin patient feasibility Draft monitoring plans Prepare Safety Management plans

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