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Innovative Biopharmaceutical Transforms Oncology Trials with MaxisIT CTOS

Company Uses CTOS Platform to Gain Broader Insights across Product Portfolio

 

October 29, 2021

New Jersey, USA – MaxisIT, a leading provider of platform technologies for clinical research, including clinical trial oversight, today announced that they have successfully completed Year 1 of a multi-year agreement with a billion-dollar global biopharmaceutical company focused on developing monoclonal antibody-based therapeutics for the treatment of cancer. The sponsor deployed MaxisIT’s Clinical Trial Oversight System (CTOS) as a strategic part of its digital transformation initiative in under 6 months.

MaxisIT’s cloud-based platform replaced multiple outdated legacy systems offering a single-source-of-truth for clinical, operational, and pre-clinical data. Use of the comprehensive data and analytics platform helped improve the performance of clinical trials, enhance decision making, and reduce costs of the company’s clinical development programs. Timing and accuracy are critical in oncology trials. The CTOS platform is reducing cycle times and providing rapid access to data, offering additional agility to the R&D team. The solution is also being used to automate the complex data ingestion to analytics & visualizations process with 20+ vendor integrations, including digital and real-world data sources. 

Oncology trials have become even more complex with the greater adoption of decentralized trials, adaptive trial designs, and new Risk-Based Quality Monitoring guidance. R&D teams need fast access to data to make more meaningful decisions about study designs, protocol compliance, enrollment, CRO performance, and patient safety.  Using MaxisIT’s CTOS, the Sponsor’s clinical teams have been accessing and processing an increasing variety and volume of data faster in an automated fashion. The user base has more than doubled in the first year and spans over a dozen clinical trial teams.  

“Our clients are recognizing reduced cycle times, increased controls, and improved data quality,“ said Moulik Shah, CEO, MaxisIT. “We are digitally transforming the clinical data supply chain with an omnichannel approach to data and insights in a trial agnostic and eClinical vendor agnostic environment. Our solution is enriching traditional, hybrid, and decentralized trials around the globe.

MaxisIT’s CTOS platform has a comprehensive set of out-of-the-box integrations to most industry-accepted eClinical apps, operational data sources and CROs’ systems. It leverages built-in intelligence that drives automation and reduces manual, error-prone steps in data management, programming, and analytical processes. Overall, it offers greater levels of standardization, reusability, and traceability across siloed clinical data, while truly empowering cross-functional clinical development teams. 

 

Additional Resources

MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
MaxisIT Twitter: @MaxisITInc

Top-20 Pharmaceutical Company Adopts Cloud Biometrics Solution to Improve Global Clinical Trial Oversight and Outcomes

Accelerating Digital Transformation and Innovation in Patient Health

August 17, 2021
New Jersey, USA – MaxisIT, a leading provider of platform technologies for clinical research, including clinical trial oversight, today announced the award of a multi-year agreement by a top-20 pharmaceutical company in the USA. The sponsor will deploy MaxisIT’s Cloud-based platform as a strategic part of its digital transformation initiative. The MaxisIT Clinical Trial Oversight System (CTOS) will replace outdated clinical data and biometrics systems. The deployment includes MaxisIT’s Data Management Workbench (DMW), Statistical Computing Environment (SCE), and Metadata Repository (MDR) offering a single-source-of-truth for clinical, operational, and pre-clinical data. Use of the comprehensive data and analytics platform will help improve the performance of clinical trials, improve decision making and reduce costs of the company’s clinical development programs by automating the data ingestion to analytics process with 50+ vendor integrations, including digital and real-world data sources.
Clinical trials have become even more complex with the greater adoption of decentralized trials, adaptive trial designs, and new Risk-Based Quality Monitoring guidance. Innovative companies are reaching beyond traditional methods and adopting a total oversight approach supported by holistic data strategy and a focus on patient centricity. In many cases, new trial designs require patients to adapt to wearable devices, in-home procedures, and telemedicine. MaxisIT’s CTOS platform unlocks the value of clinical data with trial oversight, quality management, exploration, and regulatory compliance, which reduce delays and costs across clinical development processes.
By using MaxisIT’s CTOS, biometrics and clinical teams can process the variety and volume of data faster in an automated fashion. The reduced cycle time and increased control ensure that pharmaceutical companies meet deadlines and improve data quality. Faster access to clean data allows clinical teams to focus on planning, monitoring, deriving insights and analysis in near-real-time. MaxisIT delivers Total Oversight.
“As the variety, volume, and complexity of data in clinical trials have increased clinical operations, teams, data managers, and IT groups are struggling to integrate all of this data in a way that provides value to their organizations,” said Moulik Shah, CEO, MaxisIT. “Innovative companies such as this are driving digital innovation with purpose-built platforms that support the entire clinical data value chain in a self-service manner that is delivered via a secured cloud. MaxisIT’s CTOS is successfully delivering value at a faster return on investment while ensuring regulatory compliance.”
MaxisIT’s CTOS platform has a comprehensive set of out-of-the-box integrations to most industry-accepted eClinical apps, operational data sources, and CROs’ systems. It leverages built-in intelligence that drives automation and reduces manual error-prone steps in data management, programming, and analytical processes. Overall, it offers greater levels of standardization, reusability, and traceability among siloed clinical data, while truly empowering clinical development teams across functions.
Additional Resources
MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
MaxisIT Twitter: @MaxisITInc
About MaxisIT
MaxisIT empowers the Biopharmaceutical industry with Integrated Computing, Self-service Analytics, and Enterprise Externalization via its Cloud-based Integrated Clinical Development Platform. For more information about MaxisIT, visit maxisit.com

MaxisIT Announces Pioneering SaaS Agreement with Philip Morris International for an Integrated Clinical Data Management Solution

Faster response to Patient Health via MaxisIT’s Integrated Clinical Development Platform

November 01, 2019 08:30 AM Eastern Daylight Time

METUCHEN, N.J.–(BUSINESS WIRE)–MaxisIT today announced that it has GONE LIVE with MaxisIT’s Integrated Clinical Development Platform together with Tobacco Harm Reduction pioneer, Philip Morris International (PMI). PMI has awarded MaxisIT a multi-year SaaS agreement to use MaxisIT’s Clinical Data Repository, Clinical data management Hub, Statistical computing Environment and Analytics solutions for their global clinical assessment program. This pioneering agreement for MaxisIT’s industry-leading, Integrated Platform, will replace Philip Morris International’s existing solution. With this successful and timely GO LIVE, MaxisIT reinforces its position as an industry innovator in cloud-based clinical data & analytics software solutions for risk-averse and highly regulated industry.

Planning and managing clinical studies have become more complex as the research questions are becoming increasingly more complicated and resource intensive. In order to demonstrate the effectiveness and value of the products being studies, companies must be able to handle the wide variety of data and analyze them timely for faster regulatory review. MaxisIT’s Platform enables “data-driven digital transformation” by delivering complete analytics platform from data ingestion to transformation to analysis and clinical intelligence including data-driven digital applications that truly delivers the value of data, while improving time and reducing costs in clinical development processes by in-time decision-making. This platform’s “Direct-Data-Delivery-Pipe™” intelligently automates the source to insight clinical data value chain for timely review. “At Philip Morris, we are working to develop new products to provide smokers alternative products that are a better option than continuing to smoke cigarettes. Implementing MaxisIT’s solution, will help us stay in the forefront of science, by providing us with a more robust and efficient system for clinical data management and analytics, that will ensure data quality and transparency while ultimately helping us keep pace with the speed of innovation in order to bring scientifically substantiated products to market faster,” said Sharon Carty, Director Clinical Science & Epidemiology Operations, Philip Morris International.

“Increasing variety, volume and complexity of data in clinical trials demands a holistic data strategy for clinical R&D. Data management is struggling to assimilate data across the sources and derive meaningful clinical intelligence for timely decision making,” said Maulik Shah, CEO, MaxisIT. “Industry needs an integrated and intelligent solution that is purpose-built; and supports the entire clinical data value chain in a self-service manner via secured cloud. With over 2000 clinical studies managed in cloud across the customers, MaxisIT’s Platform is delivering value at a faster return on investment,” added by Maulik Shah.

Using MaxisIT’s Integrated Platform, the clinical data management processes can reduce cycle time, achieve greater control over data and respond to quality concerns in time; furthermore, clinical researchers can have faster access to data and self-service insight.

Additional Resources
MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
Data, Analytics, Insight…faster; visit maxisit.com

MaxisIT launches a new logo. Introduces AI into its products and services

Now get Data, Analytics, Insights faster with the power of AI

By: MaxisIT Inc.

 

METUCHEN, N.J. – Oct. 25, 2019 – PRLog — MaxisIT, a premier provider of a true cloud-based integrated platform solution for clinical drug development, is introducing artificial intelligence (AI) to its products and services.

The new AI-based end-to-end clinical development platform promises to

· Deliver action-oriented Intelligence via Artificial Intelligence

· Advance (“>”) the clinical development to enable faster patient care

· Empower the patients and clinical trials stakeholders via reduced “IT” intervention in a true self-service era.

Speaking to us, Maulik Shah, CEO, MaxisIT says “We are driven to enable pharma and biotech companies to develop safe and effective drugs faster as well as deliver care to the patients in need. Our new AI-powered platform will empower the clinical trials’ stakeholders to make decisions faster based on action-oriented intelligence delivered to them in real-time ”

With the introduction of AI to its offerings, MaxisIT reinforces its position as an industry innovator in cloud-based clinical data and analytics software platform for the pharmaceutical industry. Visit https://maxisit.com

MaxisIT ® eAdaptive Announced as Best of Show Award Winner at Bio-IT World Expo 2010

MaxisIT® eAdaptive Announced as Best of Show Award Winner at Bio-IT World Expo 2010

MaxisIT® recognized for eAdaptive – innovative solution within clinical trials and research category
 
METUCHEN, NJ – April 29, 2010 – CHI’s Bio-IT World Conference & Expoannounced the products that won the Best of Show Awards at a ceremony held on Wednesday, April 21st at the World Trade Center Boston. Among the winning products, MaxisIT’s eAdaptive solution, part of CTRenaissance® suite of products has won the best-of the show award under clinical trials and research category, surpassing its competitors.

Judged by a team of Bio-IT World magazine editors and highly regarded industry experts, the Best of Show Awards recognize new products that demonstrate exceptional technology innovations across the life sciences research, discovery and clinical trials process. With a record number of entries (43 in total), the winners were judged based on the products’ technical merit, functionality, innovation and in-person presentations to the judges at the show.

Talking about eAdaptive, Mr. Maulik Shah, VP–Product Strategy stressed that eAdaptive, while serving as a unified solution for the industry, enables midcourse monitoring & adaptive decision-making in an integrated environment, apart from enabling review and analysis of a study or a group of studies under program/s within therapeutic areas.

He further added that eAdaptive shows a path forward in adaptive clinical research via its integrated ability to monitor, analyze and take cross-functional decisions during mid-course corrections; allows reusability, thus making reviewing and analysis process faster – time lag from data availability to analysis is reduced drastically by preserving the effectiveness and  the power of each decision.

The MaxisIT® website’s product page link is as follows:

MaxisIT® is pioneer in eClinical Integration and Adaptive Decison Support software, where in CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization.

ABOUT MAXISIT®

MaxisIT® is pioneer in eClinical Integration and Adaptive Decison Support software, where in CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization.

ABOUT BIO-IT WORLD CONFERENCE & EXPO

The Bio-IT World Conference & Expo (www.bio-itworldexpo.com) is a premier event, showcasing the myriad applications of IT and informatics to biomedical research and the drug discovery enterprise.
For more information, contact:
Maulik Shah
Vice President, Product Strategy
MaxisIT®, Inc.
 
MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)
CTRenaissance®
The Power to Grow
MaxisIT ® CTRenaissance wins the Bio-IT World Expo 2009 Best of Show Award

MaxisIT® CTRenaissance wins the Bio-IT World Expo 2009 Best of Show Award

MaxisIT’s CTRenaissance®; Wins the Bio-IT World Expo 2009 Best of Show Award

Clinical Trial Lifecycle Automation Software Suite CTRENAISSANCE® Wins Industry Accolades

METUCHEN, N.J.- Enterprise class software-suite CTRenaissance® has won the Bio-IT World 2009 Best of show award under Clinical Trials and Research category. This award was presented at the Bio-IT World Conference and Expo ’09 held at Boston, MA on April 27 – 29. Companies like Phase Forward and IMC were among the finalists under the same category.

Judged by a team of Bio-IT World editors and highly regarded industry experts, the Best of Show Awards recognize products released or updated in the past 12 months that demonstrate exceptional technology innovations across the life sciences research, discovery, and clinical trials industries.

“Each year our exhibitors present the tools and solutions that are critical to driving the drug discovery and clinical industries forward,” said Allison Proffitt, managing editor of Bio-IT World magazine. “There is a wealth of cutting edge and smart technologies for our judges to choose from, and we congratulate the 2009 Best of Show winners, and look forward to seeing how these new products enable and transform the industry.”

Accepting the award on behalf of the entire team, Maulik Shah, VP – Global Sales and Delivery, said, “We are truly honored and very happy to have received this award and encouraged by the industry’s response to CTRenaissance®.”

To view the complete story on Bio-IT World’s website, please visit this link – http://www.bio-itworld.com/news/2009/04/30/2009boswinners.html

About CTRenaissance®

MaxisIT’s CTRenaissance® platform is an enterprise-class, most efficient, integrated, automated and web-based software solution suite that involves no IT footprint at point-of-use and is 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 world-wide manage the pulse of their clinical trials and produce and manage clinical documents ranging from protocol to the eCTD – anytime, anywhere, on-demand.

About MaxisIT®

MaxisIT® is a premier enterprise-class clinical software and clinical functional services provider (FSP) that offers a unique blend of both, clinical trial domain and core IT expertise, with a thorough understanding of industry and regulatory standards.

MaxisIT’s CTRenaissance® and clinical FSP enable its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Our metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and a long-term partnering focus.

To view our product range, please log into – https://maxisit.com/products/index.php

For more information, contact our product specialist –

MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)

Web: www.maxisit.com

References:

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090720005941&newsLang=en

MaxisIT Launches Enterprise Scale Clinical Trial Integration and Automation Software CTRenaissance

MaxisIT® Launches Enterprise Scale Clinical Trial Integration and Automation Software CTRenaissance®

CTRENAISSANCE® – Real Time Harmonization of Composite Clinical Trials

METUCHEN, N.J.– MaxisIT® has pioneered into building a world-class enterprise scale clinical trial integration and automation software CTRenaissance® for pharmaceutical & life sciences industry.

MaxisIT’s CTRenaissance® is the most efficient, web-based, enterprise class software solution that involves no IT footprint at the point of use and is available at the most competitive investment that guarantees return.

Talking about CTRenaissance®, Mr. Maulik Shah, VP – Global Sales and Delivery, said, “This unique software-as-a-service oriented, internet solution produces clinical deliverables ranging from protocol to eCTD – anytime, anywhere, on-demand and it is as simple as using a web-based email account.”

Mr. Shah further added that CTRenaissance® provides greater flexibility, scalability and ease of planning and managing clinical trials, monitoring drug safety, and producing clinical trial deliverables in a collaborative, yet globally distributed work-environment. He said that, “With the help of this software, our customers will achieve significant time and cost savings realized through standardized, streamlined and reusable infrastructure that requires minimum manual intervention. They will also be able to manage the pulse of their clinical trials in real-time and make competitive business decisions faster with the help of its built-in business process monitoring system.”

Utilizing industry standards such CDISC, hl7 and other XML based data standards, CT Renaissance® promises to eliminate cumbersome and obsolete processes that impede timely production of deliverables. It can accommodate multiple trials in a parallel multi-user, role-based and secured environment.

Ashvee Kanwar, Director of Marketing at MaxisIT® summarized, “We strongly believe that fully functional CTRenaissance® will provide pharmaceutical businesses the power to grow, accelerating introduction of new drugs to the market and corresponding revenues, reduce overall research and development expenditures, enhance existing data quality control efforts, increase drug safety compliance and reduce clinical and economic risk.”

CTRenaissance® Overview:

  • An Enterprise class platform
  • Web-based and services oriented
  • Faster deliverables with reduced manual interventions
  • Minimum or no IT footprint at point of use
  • Increased efficiency and reduced noise
  • Supports geographically distributed user base
  • Integrated and automated processes
  • Built-in business process monitoring system
  • Reduced time to market
  • Cost effective solution

About MaxisIT®

MaxisIT® is a premier enterprise-class clinical software and clinical functional services provider (FSP) that offers a unique blend of both, clinical trial domain and core IT expertise, with a thorough understanding of industry and regulatory standards.

MaxisIT’s CTRenaissance® and clinical FSP enable its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Our metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and a long-term partnering focus.

To view our product range, please log into – https://maxisit.com/products/index.php

For more information, contact our product specialist –

MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)

Web: www.maxisit.com

More Press Releases Links

eAdaptive enhancing supporting to adaptive decision-making process and study data blinding

eAdaptive enhancing supporting to adaptive decision-making process and study data blinding

Mutuchen, November 10, 2009 – MaxisIT®, a leading global software development company has today introduced eAdaptive module under CTRenaissance® suite that is aimed to transform the way the clinical trials are conducted. The solution supports strong adaptive decision-making process and studies data blinding/unblinding management, required during the execution of adaptive clinical trials.

Talking about eAdaptive, Mr. Maulik Shah, VP-Product Strategy has outlined how the solution would bring about a sea change in the clinical domain sector, which was hitherto adopting cumbersome manual solutions, consuming lot of time and resources. eAdaptive, while serving as a unified solution for the industry, enables midcourse monitoring & adaptive decision-making in an integrated environment, apart from enabling review and analysis of a study or a group of studies under program/s within therapeutic areas.

Mr. Shah further deliberated on various benefits of using eAdaptive and stressed that the solution shows a path forward in adaptive clinical research via its integrated ability to monitor, analyze and take cross-functional decisions during mid-course corrections; allows reusability and makes reviewing and analysis process faster. He further added that the solution bridges the cross-functional domains such as enrollment, drug supply and interim statistical review – delivering an ability of knowing how each decision impacts all functional areas that would increase the accuracy of the decision and confidence of the decision maker

The MaxisIT® website’s product page link is as follows:

http://www./maxisit.com/products/product_cp_management.php

ABOUT MAXISIT®

MaxisIT® is pioneer in eClinical Integration and Adaptive Decision Support software, wherein CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization

MaxisIT® CTRenaissance® enables its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and long-term partnering strategy.

For more information, contact:

Maulik Shah

Vice President, Product Strategy

MaxisIT®, Inc.

mshah@maxisit.com

  • MaxisIT is proud to sponsor the Scope Summit for Clinical Ops Executives happening at Hyatt Regency Orlando, Orlando, FL from February 18-21, 2020. Do drop by Booth # 614 to meet us!
  • MaxisIT are proud sponsors of Phuse-Connect happening March 8th – 11th at SeaWorld, Florida.
    Come meet us at Booth #7 Click here for more info
Press releases
Innovative Biopharmaceutical Transforms Oncology Trials with MaxisIT CTOS

Company Uses CTOS Platform to Gain Broader Insights across Product Portfolio

 

October 29, 2021

New Jersey, USA – MaxisIT, a leading provider of platform technologies for clinical research, including clinical trial oversight, today announced that they have successfully completed Year 1 of a multi-year agreement with a billion-dollar global biopharmaceutical company focused on developing monoclonal antibody-based therapeutics for the treatment of cancer. The sponsor deployed MaxisIT’s Clinical Trial Oversight System (CTOS) as a strategic part of its digital transformation initiative in under 6 months.

MaxisIT’s cloud-based platform replaced multiple outdated legacy systems offering a single-source-of-truth for clinical, operational, and pre-clinical data. Use of the comprehensive data and analytics platform helped improve the performance of clinical trials, enhance decision making, and reduce costs of the company’s clinical development programs. Timing and accuracy are critical in oncology trials. The CTOS platform is reducing cycle times and providing rapid access to data, offering additional agility to the R&D team. The solution is also being used to automate the complex data ingestion to analytics & visualizations process with 20+ vendor integrations, including digital and real-world data sources. 

Oncology trials have become even more complex with the greater adoption of decentralized trials, adaptive trial designs, and new Risk-Based Quality Monitoring guidance. R&D teams need fast access to data to make more meaningful decisions about study designs, protocol compliance, enrollment, CRO performance, and patient safety.  Using MaxisIT’s CTOS, the Sponsor’s clinical teams have been accessing and processing an increasing variety and volume of data faster in an automated fashion. The user base has more than doubled in the first year and spans over a dozen clinical trial teams.  

“Our clients are recognizing reduced cycle times, increased controls, and improved data quality,“ said Moulik Shah, CEO, MaxisIT. “We are digitally transforming the clinical data supply chain with an omnichannel approach to data and insights in a trial agnostic and eClinical vendor agnostic environment. Our solution is enriching traditional, hybrid, and decentralized trials around the globe.

MaxisIT’s CTOS platform has a comprehensive set of out-of-the-box integrations to most industry-accepted eClinical apps, operational data sources and CROs’ systems. It leverages built-in intelligence that drives automation and reduces manual, error-prone steps in data management, programming, and analytical processes. Overall, it offers greater levels of standardization, reusability, and traceability across siloed clinical data, while truly empowering cross-functional clinical development teams. 

 

Additional Resources

MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
MaxisIT Twitter: @MaxisITInc

Top-20 Pharmaceutical Company Adopts Cloud Biometrics Solution to Improve Global Clinical Trial Oversight and Outcomes

Accelerating Digital Transformation and Innovation in Patient Health

August 17, 2021
New Jersey, USA – MaxisIT, a leading provider of platform technologies for clinical research, including clinical trial oversight, today announced the award of a multi-year agreement by a top-20 pharmaceutical company in the USA. The sponsor will deploy MaxisIT’s Cloud-based platform as a strategic part of its digital transformation initiative. The MaxisIT Clinical Trial Oversight System (CTOS) will replace outdated clinical data and biometrics systems. The deployment includes MaxisIT’s Data Management Workbench (DMW), Statistical Computing Environment (SCE), and Metadata Repository (MDR) offering a single-source-of-truth for clinical, operational, and pre-clinical data. Use of the comprehensive data and analytics platform will help improve the performance of clinical trials, improve decision making and reduce costs of the company’s clinical development programs by automating the data ingestion to analytics process with 50+ vendor integrations, including digital and real-world data sources.
Clinical trials have become even more complex with the greater adoption of decentralized trials, adaptive trial designs, and new Risk-Based Quality Monitoring guidance. Innovative companies are reaching beyond traditional methods and adopting a total oversight approach supported by holistic data strategy and a focus on patient centricity. In many cases, new trial designs require patients to adapt to wearable devices, in-home procedures, and telemedicine. MaxisIT’s CTOS platform unlocks the value of clinical data with trial oversight, quality management, exploration, and regulatory compliance, which reduce delays and costs across clinical development processes.
By using MaxisIT’s CTOS, biometrics and clinical teams can process the variety and volume of data faster in an automated fashion. The reduced cycle time and increased control ensure that pharmaceutical companies meet deadlines and improve data quality. Faster access to clean data allows clinical teams to focus on planning, monitoring, deriving insights and analysis in near-real-time. MaxisIT delivers Total Oversight.
“As the variety, volume, and complexity of data in clinical trials have increased clinical operations, teams, data managers, and IT groups are struggling to integrate all of this data in a way that provides value to their organizations,” said Moulik Shah, CEO, MaxisIT. “Innovative companies such as this are driving digital innovation with purpose-built platforms that support the entire clinical data value chain in a self-service manner that is delivered via a secured cloud. MaxisIT’s CTOS is successfully delivering value at a faster return on investment while ensuring regulatory compliance.”
MaxisIT’s CTOS platform has a comprehensive set of out-of-the-box integrations to most industry-accepted eClinical apps, operational data sources, and CROs’ systems. It leverages built-in intelligence that drives automation and reduces manual error-prone steps in data management, programming, and analytical processes. Overall, it offers greater levels of standardization, reusability, and traceability among siloed clinical data, while truly empowering clinical development teams across functions.
Additional Resources
MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
MaxisIT Twitter: @MaxisITInc
About MaxisIT
MaxisIT empowers the Biopharmaceutical industry with Integrated Computing, Self-service Analytics, and Enterprise Externalization via its Cloud-based Integrated Clinical Development Platform. For more information about MaxisIT, visit maxisit.com

MaxisIT Announces Pioneering SaaS Agreement with Philip Morris International for an Integrated Clinical Data Management Solution

Faster response to Patient Health via MaxisIT’s Integrated Clinical Development Platform

November 01, 2019 08:30 AM Eastern Daylight Time

METUCHEN, N.J.–(BUSINESS WIRE)–MaxisIT today announced that it has GONE LIVE with MaxisIT’s Integrated Clinical Development Platform together with Tobacco Harm Reduction pioneer, Philip Morris International (PMI). PMI has awarded MaxisIT a multi-year SaaS agreement to use MaxisIT’s Clinical Data Repository, Clinical data management Hub, Statistical computing Environment and Analytics solutions for their global clinical assessment program. This pioneering agreement for MaxisIT’s industry-leading, Integrated Platform, will replace Philip Morris International’s existing solution. With this successful and timely GO LIVE, MaxisIT reinforces its position as an industry innovator in cloud-based clinical data & analytics software solutions for risk-averse and highly regulated industry.

Planning and managing clinical studies have become more complex as the research questions are becoming increasingly more complicated and resource intensive. In order to demonstrate the effectiveness and value of the products being studies, companies must be able to handle the wide variety of data and analyze them timely for faster regulatory review. MaxisIT’s Platform enables “data-driven digital transformation” by delivering complete analytics platform from data ingestion to transformation to analysis and clinical intelligence including data-driven digital applications that truly delivers the value of data, while improving time and reducing costs in clinical development processes by in-time decision-making. This platform’s “Direct-Data-Delivery-Pipe™” intelligently automates the source to insight clinical data value chain for timely review. “At Philip Morris, we are working to develop new products to provide smokers alternative products that are a better option than continuing to smoke cigarettes. Implementing MaxisIT’s solution, will help us stay in the forefront of science, by providing us with a more robust and efficient system for clinical data management and analytics, that will ensure data quality and transparency while ultimately helping us keep pace with the speed of innovation in order to bring scientifically substantiated products to market faster,” said Sharon Carty, Director Clinical Science & Epidemiology Operations, Philip Morris International.

“Increasing variety, volume and complexity of data in clinical trials demands a holistic data strategy for clinical R&D. Data management is struggling to assimilate data across the sources and derive meaningful clinical intelligence for timely decision making,” said Maulik Shah, CEO, MaxisIT. “Industry needs an integrated and intelligent solution that is purpose-built; and supports the entire clinical data value chain in a self-service manner via secured cloud. With over 2000 clinical studies managed in cloud across the customers, MaxisIT’s Platform is delivering value at a faster return on investment,” added by Maulik Shah.

Using MaxisIT’s Integrated Platform, the clinical data management processes can reduce cycle time, achieve greater control over data and respond to quality concerns in time; furthermore, clinical researchers can have faster access to data and self-service insight.

Additional Resources
MaxisIT Integrated Clinical Development Platform
MaxisIT Cloud Services Video
Data, Analytics, Insight…faster; visit maxisit.com

MaxisIT launches a new logo. Introduces AI into its products and services

Now get Data, Analytics, Insights faster with the power of AI

By: MaxisIT Inc.

 

METUCHEN, N.J. – Oct. 25, 2019 – PRLog — MaxisIT, a premier provider of a true cloud-based integrated platform solution for clinical drug development, is introducing artificial intelligence (AI) to its products and services.

The new AI-based end-to-end clinical development platform promises to

· Deliver action-oriented Intelligence via Artificial Intelligence

· Advance (“>”) the clinical development to enable faster patient care

· Empower the patients and clinical trials stakeholders via reduced “IT” intervention in a true self-service era.

Speaking to us, Maulik Shah, CEO, MaxisIT says “We are driven to enable pharma and biotech companies to develop safe and effective drugs faster as well as deliver care to the patients in need. Our new AI-powered platform will empower the clinical trials’ stakeholders to make decisions faster based on action-oriented intelligence delivered to them in real-time ”

With the introduction of AI to its offerings, MaxisIT reinforces its position as an industry innovator in cloud-based clinical data and analytics software platform for the pharmaceutical industry. Visit https://maxisit.com

MaxisIT ® eAdaptive Announced as Best of Show Award Winner at Bio-IT World Expo 2010

MaxisIT® eAdaptive Announced as Best of Show Award Winner at Bio-IT World Expo 2010

MaxisIT® recognized for eAdaptive – innovative solution within clinical trials and research category
 
METUCHEN, NJ – April 29, 2010 – CHI’s Bio-IT World Conference & Expoannounced the products that won the Best of Show Awards at a ceremony held on Wednesday, April 21st at the World Trade Center Boston. Among the winning products, MaxisIT’s eAdaptive solution, part of CTRenaissance® suite of products has won the best-of the show award under clinical trials and research category, surpassing its competitors.

Judged by a team of Bio-IT World magazine editors and highly regarded industry experts, the Best of Show Awards recognize new products that demonstrate exceptional technology innovations across the life sciences research, discovery and clinical trials process. With a record number of entries (43 in total), the winners were judged based on the products’ technical merit, functionality, innovation and in-person presentations to the judges at the show.

Talking about eAdaptive, Mr. Maulik Shah, VP–Product Strategy stressed that eAdaptive, while serving as a unified solution for the industry, enables midcourse monitoring & adaptive decision-making in an integrated environment, apart from enabling review and analysis of a study or a group of studies under program/s within therapeutic areas.

He further added that eAdaptive shows a path forward in adaptive clinical research via its integrated ability to monitor, analyze and take cross-functional decisions during mid-course corrections; allows reusability, thus making reviewing and analysis process faster – time lag from data availability to analysis is reduced drastically by preserving the effectiveness and  the power of each decision.

The MaxisIT® website’s product page link is as follows:

MaxisIT® is pioneer in eClinical Integration and Adaptive Decison Support software, where in CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization.

ABOUT MAXISIT®

MaxisIT® is pioneer in eClinical Integration and Adaptive Decison Support software, where in CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization.

ABOUT BIO-IT WORLD CONFERENCE & EXPO

The Bio-IT World Conference & Expo (www.bio-itworldexpo.com) is a premier event, showcasing the myriad applications of IT and informatics to biomedical research and the drug discovery enterprise.
For more information, contact:
Maulik Shah
Vice President, Product Strategy
MaxisIT®, Inc.
 
MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)
CTRenaissance®
The Power to Grow
MaxisIT ® CTRenaissance wins the Bio-IT World Expo 2009 Best of Show Award

MaxisIT® CTRenaissance wins the Bio-IT World Expo 2009 Best of Show Award

MaxisIT’s CTRenaissance®; Wins the Bio-IT World Expo 2009 Best of Show Award

Clinical Trial Lifecycle Automation Software Suite CTRENAISSANCE® Wins Industry Accolades

METUCHEN, N.J.- Enterprise class software-suite CTRenaissance® has won the Bio-IT World 2009 Best of show award under Clinical Trials and Research category. This award was presented at the Bio-IT World Conference and Expo ’09 held at Boston, MA on April 27 – 29. Companies like Phase Forward and IMC were among the finalists under the same category.

Judged by a team of Bio-IT World editors and highly regarded industry experts, the Best of Show Awards recognize products released or updated in the past 12 months that demonstrate exceptional technology innovations across the life sciences research, discovery, and clinical trials industries.

“Each year our exhibitors present the tools and solutions that are critical to driving the drug discovery and clinical industries forward,” said Allison Proffitt, managing editor of Bio-IT World magazine. “There is a wealth of cutting edge and smart technologies for our judges to choose from, and we congratulate the 2009 Best of Show winners, and look forward to seeing how these new products enable and transform the industry.”

Accepting the award on behalf of the entire team, Maulik Shah, VP – Global Sales and Delivery, said, “We are truly honored and very happy to have received this award and encouraged by the industry’s response to CTRenaissance®.”

To view the complete story on Bio-IT World’s website, please visit this link – http://www.bio-itworld.com/news/2009/04/30/2009boswinners.html

About CTRenaissance®

MaxisIT’s CTRenaissance® platform is an enterprise-class, most efficient, integrated, automated and web-based software solution suite that involves no IT footprint at point-of-use and is 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 world-wide manage the pulse of their clinical trials and produce and manage clinical documents ranging from protocol to the eCTD – anytime, anywhere, on-demand.

About MaxisIT®

MaxisIT® is a premier enterprise-class clinical software and clinical functional services provider (FSP) that offers a unique blend of both, clinical trial domain and core IT expertise, with a thorough understanding of industry and regulatory standards.

MaxisIT’s CTRenaissance® and clinical FSP enable its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Our metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and a long-term partnering focus.

To view our product range, please log into – https://maxisit.com/products/index.php

For more information, contact our product specialist –

MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)

Web: www.maxisit.com

References:

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090720005941&newsLang=en

MaxisIT Launches Enterprise Scale Clinical Trial Integration and Automation Software CTRenaissance

MaxisIT® Launches Enterprise Scale Clinical Trial Integration and Automation Software CTRenaissance®

CTRENAISSANCE® – Real Time Harmonization of Composite Clinical Trials

METUCHEN, N.J.– MaxisIT® has pioneered into building a world-class enterprise scale clinical trial integration and automation software CTRenaissance® for pharmaceutical & life sciences industry.

MaxisIT’s CTRenaissance® is the most efficient, web-based, enterprise class software solution that involves no IT footprint at the point of use and is available at the most competitive investment that guarantees return.

Talking about CTRenaissance®, Mr. Maulik Shah, VP – Global Sales and Delivery, said, “This unique software-as-a-service oriented, internet solution produces clinical deliverables ranging from protocol to eCTD – anytime, anywhere, on-demand and it is as simple as using a web-based email account.”

Mr. Shah further added that CTRenaissance® provides greater flexibility, scalability and ease of planning and managing clinical trials, monitoring drug safety, and producing clinical trial deliverables in a collaborative, yet globally distributed work-environment. He said that, “With the help of this software, our customers will achieve significant time and cost savings realized through standardized, streamlined and reusable infrastructure that requires minimum manual intervention. They will also be able to manage the pulse of their clinical trials in real-time and make competitive business decisions faster with the help of its built-in business process monitoring system.”

Utilizing industry standards such CDISC, hl7 and other XML based data standards, CT Renaissance® promises to eliminate cumbersome and obsolete processes that impede timely production of deliverables. It can accommodate multiple trials in a parallel multi-user, role-based and secured environment.

Ashvee Kanwar, Director of Marketing at MaxisIT® summarized, “We strongly believe that fully functional CTRenaissance® will provide pharmaceutical businesses the power to grow, accelerating introduction of new drugs to the market and corresponding revenues, reduce overall research and development expenditures, enhance existing data quality control efforts, increase drug safety compliance and reduce clinical and economic risk.”

CTRenaissance® Overview:

  • An Enterprise class platform
  • Web-based and services oriented
  • Faster deliverables with reduced manual interventions
  • Minimum or no IT footprint at point of use
  • Increased efficiency and reduced noise
  • Supports geographically distributed user base
  • Integrated and automated processes
  • Built-in business process monitoring system
  • Reduced time to market
  • Cost effective solution

About MaxisIT®

MaxisIT® is a premier enterprise-class clinical software and clinical functional services provider (FSP) that offers a unique blend of both, clinical trial domain and core IT expertise, with a thorough understanding of industry and regulatory standards.

MaxisIT’s CTRenaissance® and clinical FSP enable its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Our metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and a long-term partnering focus.

To view our product range, please log into – https://maxisit.com/products/index.php

For more information, contact our product specialist –

MaxisIT Inc
510 Thornall Street, Suite 180, Edison, NJ 08837
Email : info@maxisit.com
Phone : +1 732-494-2005, ext. 135
1-877-MAXISIT (629-4748)

Web: www.maxisit.com

More Press Releases Links

eAdaptive enhancing supporting to adaptive decision-making process and study data blinding

eAdaptive enhancing supporting to adaptive decision-making process and study data blinding

Mutuchen, November 10, 2009 – MaxisIT®, a leading global software development company has today introduced eAdaptive module under CTRenaissance® suite that is aimed to transform the way the clinical trials are conducted. The solution supports strong adaptive decision-making process and studies data blinding/unblinding management, required during the execution of adaptive clinical trials.

Talking about eAdaptive, Mr. Maulik Shah, VP-Product Strategy has outlined how the solution would bring about a sea change in the clinical domain sector, which was hitherto adopting cumbersome manual solutions, consuming lot of time and resources. eAdaptive, while serving as a unified solution for the industry, enables midcourse monitoring & adaptive decision-making in an integrated environment, apart from enabling review and analysis of a study or a group of studies under program/s within therapeutic areas.

Mr. Shah further deliberated on various benefits of using eAdaptive and stressed that the solution shows a path forward in adaptive clinical research via its integrated ability to monitor, analyze and take cross-functional decisions during mid-course corrections; allows reusability and makes reviewing and analysis process faster. He further added that the solution bridges the cross-functional domains such as enrollment, drug supply and interim statistical review – delivering an ability of knowing how each decision impacts all functional areas that would increase the accuracy of the decision and confidence of the decision maker

The MaxisIT® website’s product page link is as follows:

http://www./maxisit.com/products/product_cp_management.php

ABOUT MAXISIT®

MaxisIT® is pioneer in eClinical Integration and Adaptive Decision Support software, wherein CT Renaissance® – clinical enterprise suite solutions can integrate and orchestrate under one uniform or hybrid plug-n-play architecture, supporting end-to-end functionalities with required interoperability, reusability and scalability with Real time Harmonization

MaxisIT® CTRenaissance® enables its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Metrics for success include strategic enterprise-wide reusable and scalable solutions and world-class services team with industry’s best people, processes, technologies and long-term partnering strategy.

For more information, contact:

Maulik Shah

Vice President, Product Strategy

MaxisIT®, Inc.

mshah@maxisit.com

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VOICE OF CUSTOMERS

“Having the highest quality clinical data and related information with efficient analytical tools available at all times is critical to managing our clinical programs and accelerating our innovation; and with MaxisIT’s Integrated Clinical Development Cloud, it was easy to achieve that across the portfolio of studies, and we were able to improve the quality of data and speed of decisions without increasing our support staff.”
Head of Clinical Projects
Multi-billion dollar pharma organization focused into rare disease
"Managing trials cost-effectively, and timely have been the biggest priorities in small biotech organizations with potential to grow; MaxisIT’s Integrated Platform just delivered that by allowing us to get faster access to data via clinical data repository, and role-based & self-service A&R platform to keep track of our clinical, operational, and administrative performance across the portfolio of oncology trials.”
Sr. Director, Project and Clinical Data Management
Oncology Biotech Company
“Implementation of MaxisIT’s clinical data repository enabled us easier, and faster access to our outsourced trials’ data in the most user-friendly manner, which improved our ability to respond to data quality issues, and conduct clinical data review in timely manner.”
Executive Director and Senior Physician Project Leader
Neurosciences Focused Business Subsidiary of one of the top 10 Pharmaceutical Companies
“Right combination of technology, process, and qualified people delivered via MaxisIT partnership enabled us to achieve above 50% reduction in protocol cycle time across the portfolio of trials, and also establish clear visibility across the trial performance.”
Head, Clinical Data Management
A Multi-billion Medical device company

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