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).
Expertise from Veristat's regulatory, statistical, medical and communications experts prepared 120 INDs/CTAs in the last 3 years.
Considerations During Clinical Trial Planning & Design
A full interdisciplinary team is ready to develop the clinical trial protocol including -
Choice of control group
Selection of starting dose
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
- 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
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