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LIFE SCIENCE SERVICE

AVTECH provides unparalleled service in contract staffing/consulting and providing high level technical project support for IT, Finance, Pharmaceutical, Biotechnology, Healthcare, CRO and other Life Science companies.  Whether you are looking for a way to accomplish more with your budget while lowering risk through our competitively priced project rates and quality guarantees or need to hire a highly qualified and experienced consultant with little or no notice, AVTECH is always here to support your goals and help you tackle the most difficult challenges.

 

Clinical Data Management

 

We have the resources you need to design a clinical program that can increase efficiencies across the board. Whether you’re a small biotech start-up looking to stretch your cash and design the ideal clinical trial or a large, multi-national pharmaceutical company looking for a second opinion, we have the expert clinical data managers to offer solutions at every stage of the clinical drug development process.  

Data Management:

 

  • Electronic Data Capture (EDC) Implementation and Integration

  • Database Design

  • Edit Checks and Data Cleaning

  • Issue Resolution

  • Database Close and Lock

Clinical SAS Data Analysis

 

AVTECH has state-of-the-art technologies and processes that empower our talented core project team to be the best in the world for projects requiring expertise in CDISC, Data Management, Business Intelligence, Project Management, Clinical, Statistical Programming and IND/NDA Submissions and other Information Technologies.

 

AVTECH offers outstanding consultant and staff specifically to:

 

  • Pharmaceutical Industries

  • Biotechnology Industries

  • Health Care industries

  • CRO (contract research organization)

Good at IND/NDA submission, CDISC, Data Management, Business Intelligence, Project Management, Clinical/Statistical Programming

 

Clinical Trials:

 

  • Proof of Concept

  • Preclinical PK/PD Analysis

  • Phase I, Phase II and Phase III Safety and Efficacy Analysis

  • Phase IV Post Marketing Research

  • Adaptive Study Design

  • Protocol and Case Report Form Development

  • Statistical Analysis Plan

  • IND/NDA Submission

 

SAS and Statistical Programming/Analysis:

 

  • Table Generation

  • Patient Listings

  • Figures and Graphics

  • Integrated Summaries (ISS/ISE)

  • CDISC Standardization:

  • Study Data Tabulation Model (SDTM 3.1.2/3.1.3)

  • Analysis Data Model (ADaM 2.1)

  • CRF Annotation and Mapping Specification

  • CDISC Conversion of Legacy data

 

Health Care:

 

  • HIPAA Compliance

  • Electronic Health Records

  • Clinical Data Integration

  • Clinical Data Warehousing and Data Mining Services

  • Health Economics

  • Health Outcomes Research

  • Evidence Based Medicine

 

Pharmacovigilance (Drug Safety)

 

As a leader in pharmacovigilance, AVTECH provides services to companies of all sizes. Our commitment to drug safety allows your company to focus on what you do best – managing your core business, while we focus on what we do best – keeping all patients safe and protecting your company.

 

Our expert team provides drug safety and risk management services for pharmaceutical, biotech, consumer health, animal health, and medical device companies to ensure timely submission of quality adverse event data to various regulatory authorities across the globe.

 

Pharmacovigilance and drug safety includes all activities relating to the detection, understanding, assessment and prevention of drug related problems and any adverse effects they may have.

 

Pharmacovigilance science focuses on drug safety and ensuring no one is adversely harmed while using medical drugs. Due to the critical nature of pharmacovigilance training and consulting, there is a high demand for streamlined processes and optimal technology from consulting companies specializing in pharmacovigilance.

 

Quality & Compliance 

 

AVTECH has made it our life’s work to protect your business with quality control measures to keep your business highly efficient. We invest money, time and research to provide you with the best services available to propel your business into the next level of success. Contact us today to discuss how we can implement our strategies to keep your quality standards high and your company in compliance.  

 

Regulatory Affairs 

 

Are your customers raving about you on social media? Share their great stories to help turn potential customers into loyal ones. 

 

Validations 

 

AVTECH uses its combined experience and understanding of pharmaceuticals, biotechnology and medical device industries to provide clients with total validation services, including computer systems validation, equipment validation, and process validation and cleaning validation. We understand the extreme importance of ensuring reliability and integrity of business information, so we only hire team members who have the proper validation background.  

© 2019 by Avtech Technology Inc

 

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