Services Aspirex Offers

About Us

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 research 

- 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



Therapeutic Expertise

Our therapeutic expertise includes, but not limited to, the following areas:

- Oncology

- Cardiopulmonary

- CNS

- Vaccine

- Immunology

- Metabolic

- Infectious disease

- GI

- Dermatology

Contacting Information

Aspirex Consulting Corporation

11 Deer Park Drive

Monmouth Junction, NJ 08852

Tel: 609-481-8810

Fax: 1-888-241-0768

Email: in@acentex.com


Copyright © 2018 Aspirex Consulting Corporation