At MAInc, our statisticians become involved with researchers at the protocol stage by aiding in the formulation of important questions and determination of the appropriate design to best answer the posed questions. We analyze the data and provide useful and informative statistical reports using graphics and tables to convey the appropriate information.
For biopharmaceutical researchers, we participate in interactions with regulatory agencies (i.e. FDA and APHIS). We are aggressive in promoting the use of newly available statistical methods in product development.
- Protocol Development
- eSubmissions GLP/GCP
- EU Submissions
- FDA/CVM Submissions
- USDA/APHIS/CVB Submissions
- Bioequivalence
- Mitigated Fraction
- Prevented Fraction
- Dose Determination
- Stability Analysis
- Validation Studies
- Target Animal Safety(TAS)
- Data Safety Management Board (DSMB)
- Variety Trials and other Agronomic Studies
