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MaxisIT  

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 White Papers
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


Products » CT Renaissance

CT Renaissance™, enterprise-class completely integrated and automated software suite for clinical trials, offers the most efficient, web-based software solutions that involve no IT footprint at the point of use captures all the regulatory requirements are available at the most competitive investment that guarantees return.  

 

As simple as using a web-based email account, this software-as-a-service oriented, internet solution helps MaxisIT’s small to large customers worldwide manage their clinical trials and produce clinical deliverables ranging from protocol to eCTD – anytime, anywhere, on-demand. All the functional processes are integrated and automated based on industry standards, reusable meta-data and parameter driven processes. These services oriented web-based software solutions provide the means to accommodate multiple trials and global user-base in parallel, role-based, secured and collaborative work-environment.
 
CT Renaissance™ helps realize significant time and cost savings through standardized, streamlined and reusable infrastructure requiring minimum user intervention. It facilitates real-time monitoring of clinical trials enabling faster competitive business decisions with the help of its built-in business process monitoring & reporting system. 

With the help of CT Renaissance™, our customers are able to focus on core research, constantly innovate and scale-up, make faster deliverables and smarter business decisions. CT Renaissance gives our customers “The power to grow.

CT Renaissance™ Software Solutions

Available as independent software solutions and as an integral part of CT Renaissance™

eCollabora

Collaborative Document Writing, Reviewing and Tracking (eCollabora™): Standardized yet customizable templates of Protocol | SAP | CSR | SOPs | Investigator Brochure | CRF | Other Medical writing

eRoI

Electronic Repository of Intelligence (eRoI™): Electronic Documents | Content | Metadata Management

eNsure

SDTM Validation: Easy and intuitive web-based software for faster, more efficient SDTM validation

eDefine

DEFINE.xml: Easy and intuitive web-based software for faster, more efficient DEFINE.XML generation

eNalyze

Clinical Data Analysis and Reports Development: Utilizing web-based wizard driven interfaces, automated batch and/or real-time production of:

  • Pre-clinical safety reports
  • Interim analysis and reporting
  • Clinical data viewing and ad-hoc reporting
  • Clinical efficacy and safety analysis and reports
  • Patient profiles
  • Non-clinical reports
  • Progress monitoring Reports

eProfile

Patient Profiles

eSUBMIT 

 

  • Electronic Submission (eSUBMIT™): eCTD, RPS, Multi-Region
  • Structured Product Labeling: Support to SPL 4.0

OTHER SOFTWARE ADD-ONS

  • Clinical Trial Business Process Manager: Management of Trial | Site |Drug Inventory | Finance | Enterprise
  • Patient Randomization
  • Samples Size Determination
  • Clinical Data Management: Medical Coding | | Data Mapping
  • Business Process Engine: Clinical Trial Business Process Designer,  Process Integrator and business rules definition in a web-based environment
  • Integration Adapters
     
 Customers




 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.

MaxisIT derives successful implementation of a web-based


 Press Releases
MaxisIT recognized for eAdaptive – innovative solution within clinical trials and research category
 
METUCHEN, NJ – April 29, 2010 – CHI’s Bio-IT World Confer

 Product Contact

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

MaxisIT Inc.
203 Main Street,
Metuchen, NJ-08840




 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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