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Amscottech, is an IT Resource Management and Consultancy firm that offers some benefit IT administrations to the associations with Trustworthiness and deal with the information

Statistical Programming
In our efforts to provide the high-quality statistical services, we strive to stay incorporated inside the undertaking from start to complete and work carefully collectively with the sponsor to expand statistical plans that pleasant support regulatory requirements at the same time as meeting sponsor’s desires and requirements in interpreting and providing scientific facts.
Specific areas of our understanding consist of:
- PK/PD evaluation
- Design of Experiments – Including high order crossover designs
- Regulatory shows for FDA, EMEA organizations and neighborhood European Agencies
Our statistical services, which comply with regulatory requirements and ICH recommendations for statistical principals and reporting, include: writing statistical sections of preclinical and Phase I-IV protocols, sample size calculations and randomization schedules, statistical analysis plans (SAPs), specifications for case report tabulations, integrated summaries of safety and efficacy and statistical reports.
We have tremendous enjoy in offering these services for NDA/sNDA/BLA/510K submissions in addition to for product labeling, launch guidance and guide plans.
Amscottech., combines appropriate validated software such as SAS®, S-Plus® and StatXact® with the expertise and experience so that the programs work for the sponsor in the most efficient way.
Quick Link
- 32820 Brooks Hawk Ln Wesley Chapel 33543 FL
- hr.amscottech@amscottech.com
- Phone: + 1 859 420 7748
- Flax: 813 469 4747