Preclinical Documentation Services
Filing an Investigational New Drug (IND) Application is the first step towards beginning clinical trials. An appropriately designed package of studies; conducted with the right controls, appropriate statistical tests and accurately documented results are paramount for successful filing. ASK Scientific provides preclinical documentation services from reviewing study plans to ensuring results are reported correctly. We can review or develop documentation based on your needs.
Our Preclinical Documentation Services include:
Study Plan Design
You have a lead compound and are in the process of undertaking preclinical toxicity studies. However, the study design must conform to OECD Guidelines for obtaining regulatory approval. We will design your study plan based on your requirement and ensure it meets OECD Guidelines
Study Plan Review
You have already designed your study, but want to confirm that your study plan meets OECD Guideline requirements. We can review the study plan in detail and recommend modifications according to OECD requirements.
Study Report Review
We will review your preclinical toxicology study report for clarity, internal consistency and flow.
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