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MaxisIT  

 
 

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 Center of Excellence

Center Of Excellence - Backbone to the Services Delivery and Solutions Development Group at Ma...


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Adaptive mid-course correction via cross-functional monitoring and decision-making

Imputing ISO8601 dates from character variables containing partial dates

A scalable platform for clinical trials - Interoperability and automation in a web-based environment

A Relational Understanding of SDTM Tables


Services » Clinical Functional Services » Electronic Submission » Overview

MaxisIT realizes regulatory submissions form an important area of any trial, and that submission is the task that requires utmost attention. The submission documents should be as per the standards set by the regulatory body for a better view and faster processing of the submitted document till approval. Hence MaxisIT believes it is essential to collect the clinical trial documents and put the final submission document as per the prescribed standards.

MaxisIT’s regulatory affairs team provides flexible and responsive services according to your needs and assists you in meetings with regulatory authorities, provide scientific advice and define a regulatory strategy.

Clinical Functional Services,CDISC Services

 

MaxisIT Regulatory Submission Services Include: 

  • Regulatory compliance
  • Version control
  • CDISC domain data sets
  • Transport data sets
  • Define XML document
  • eCTD (Electronic Common Technical Document)
 Clients

Client Online is a password-protected site that provides Project knowledge base, project management tools, and the other documents. If you are a MaxisIT client with a current contract and would like access to our portal, please send an email from your company domain address to


 Success Stories

A major pharmaceutical organization accomplishes FDA eSubmissions with the help of MaxisIT.

MaxisIT standardizes clinical trial systems for a large pharmaceutical organization with the help of CDISC data standard models.


 Testimonials

I recommended that our IT and Operations groups partner with MaxisITInc because they are an independent company that can function as an advisor to our organization. Their experiences and capabilities allow them to act as a translator and trainer between Information Technology and our business units.


 Partners and Alliances

 

 


 Services Contact

Contact our Services Specialist at our Corporate Headquarters in Metuchen, NJ.

MaxisIT Inc.
203 Main Street,
Metuchen, NJ-08840
Ph.732-494-2005


 CT Renaissance

eCollabora

eRoI

eNsure

eDefine

eAnalyze

eProfile

eSUBMIT


 Clinical FSP

Clinical Data Management

Biostatistics and SAS Services

CDISC and Regulatory Services

Documents Management

Collaborative Medical Writing

Electronic Submission (eCTD)


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