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MaxisIT has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the clinical research process. Hence we provide a number of services on the lines of CDISC. - CDISC mapping specification document
- SDTM, ADaM domain datasets generation
- Applications development using CDISC standards
- Legacy study conversion
- ISS/ISE studies standardization
- Comprehensive validation of SDTM & ADaM datasets
- Define XML document
- eCTD development & validation
- CDISC training
MaxisIT realizes Regulatory Submissions form an important area of any trial, and also understands submissions is the task that requires utmost attention and the submission documents should be as per the standards of the regulatory body for the better view and faster processing of the submitted data till approval. Hence MaxisIT believes it is mandatory to collect the clinical trial data and put the final submission data as per the formats of the standards. 
MaxisIT regulatory affairs team staff provides flexible and responsive services according to your needs, MaxisIT regulatory affairs team assists you in meetings with regulatory authorities provide scientific advice and define a regulatory strategy.
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| Clients |
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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 |
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| Success Stories |
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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.
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| Testimonials |
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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.
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| Services Contact |
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Contact our Services Specialist at our Corporate Headquarters in Metuchen, NJ.
MaxisIT Inc.
203 Main Street,
Metuchen, NJ-08840
Ph.732-494-2005
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| Clinical FSP |
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Site Specifications
