(1) TechData Partners for outsourcing clinical research projects.
(2) TechData Partners for FSP (Functional Service Provider) service.
Services can be provided either at TechData Service Company facilities for outsourcing projects from clients or in the client's facilities by our experienced employees for supporting outsourcing clinical study projects. Our major strength is in the following pharmaceutical R&D programs:
Phase 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