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).
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:
Develop the clinical trial protocol including -
Regulatory Planning/Medical Writing
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|