TechnoSTAT

We make it Professional

Statistics

Providing state-of-the-art biostatistical services to companies developing pharmaceuticals and medical devices. Specializing in clinical trial design, statistical analysis planning, statistical programming, study interim and final reports and regulatory representation at FDA, EMA, PMDA and CFDA.

Data Management

Providing high-quality and reliable clinical data management services. Experts in CRF design and EDC studies. Offering our unique CleanDATA® solution for paper CRF studies. Our professional team will work closely with your company through all stages of your clinical trial, ensuring high quality standards of data management processes.

CRO Services

Providing CRO services for clinical trials conducted in Israel and project management service worldwide.  Providing regulatory expertise and clinical protocol advice to ensure the best clinical study design.

CDISC

The US FDA recommends using CDISC standards for electronic submissions of all clinical data and requires compliance with CDISC standards in drug and biologics submissions for all new clinical studies starting from 2017. Similar requirements by other regulatory agencies (e.g. EMA and PMDA) are expected in the near future.

Statistics

Providing state-of-the-art biostatistical services to companies developing pharmaceuticals and medical devices. Specializing in clinical trial design, statistical analysis planning, statistical programming, study interim and final reports and regulatory representation at FDA, EMA, PMDA and CFDA.

Data Management

Providing high-quality and reliable clinical data management services. Experts in CRF design and EDC studies. Offering our unique CleanDATA® solution for paper CRF studies. Our professional team will work closely with your company through all stages of your clinical trial, ensuring high quality standards of data management processes.

CRO Services

Providing CRO services for clinical trials conducted in Israel and project management service worldwide.  Providing regulatory expertise and clinical protocol advice to ensure the best clinical study design.

CDISC

The US FDA recommends using CDISC standards for electronic submissions of all clinical data and requires compliance with CDISC standards in drug and biologics submissions for all new clinical studies starting from 2017. Similar requirements by other regulatory agencies (e.g. EMA and PMDA) are expected in the near future.

Our clients say

TechnoSTAT’s news & Events

27.8.2019

ApiFix Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents.

15.4.2020

UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer.

01.05.2020

Sweden - announced that it has received approval from the US Food and Drug Administration (FDA) for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection.

About TechnoSTAT Clinical Services:

TechnoSTAT Clinical services is a private Israeli company, serving clients internationally.

TechnoSTAT offers a range of services from the early stages of clinical study design through the process of regulatory submission, representation and communication with the regulatory agencies (FDA, EMA)

Since its inception in 1993, TechnoSTAT has worked closely with the pharmaceutical and biotechnology industries and with scientists in numerous areas of medical research.

Address: 17 Metsada Street, 12th Floor , Bnei Brak, 5120118. Israel

Tel: +972-9-7669333 
Email: info@technostat.co.il

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