Aspirex offers an exceptional breadth of services by operating in the following areas:
Phase I, II, III and IV clinical trials
- Clinical data management including CRF design, EDC, paper based data entry, query, reports, etc.
- Clinical research, clinical data and statistical analyses using SAS
- Medical writing including clinical study reports (CSR), common technical document (CTD) and manuscripts
- Data validation including edit check
- Study Design and clinical trial protocol development
- Preparation of statistical analysis plans (SAP)
- Generation and validation of SAS datasets and tables/listings/figures
- CRF review,
- Support FDA submission including NDA, sBLA, ISS, ISE, and IND Updates.
- Define.pdf to support FDA submission
- Design, develop and implement data-driven clinical applications.
- Provide certified consultation on clinical database system capacity planning, deployment, administration performance analysis and optimization.
Phase I pharmacokinetic/pharmacodynamic evaluations
- Study designs and research protocols for pharmacokinetic and bioavailability evaluations in animal models and humans.
- Pharmacokinetic studies for drug metabolites.
- Pharmacokinetic and pharmacodynamic modeling.
- Drug-drug and drug-food interaction study design and implementation.
- Evaluation of results and generation of pharmacokinetic profiles and parameters.
- Generation or review of technical documentation including CSR.
- Outcome and QOL research using clinical trial data
- Marketing analyses using pharmaceutical prescription and claim database analyses
- Product safety and observational studies
- Medical writing including publication and manuscript
Our therapeutic expertise includes, but not limited to, the following areas:
- Infectious disease
Aspirex Consulting Corporation
11 Deer Park Drive
Monmouth Junction, NJ 08852
Copyright © 2018 Aspirex Consulting Corporation