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CTO Jason Rock Joins International Conference on Harmonisation (ICH) Delegates - Friday, October 23, 2009

Beginning tonight, GlobalSubmit CTO Jason Rock joins the delegates of the International Conference on Harmonisation as they meet to discuss answering specific questions submitted by the general public and addressing frequently asked questions. The ICH will also take on the task of developing a project plan and timeline for Regulated Product Submissions (RPS). We'll keep you updated on relevant information generated from this meeting.

Mistry, Vistage & Philadelphia Mayor Michael Nutter Meet to Discuss Business - Thursday, October 22, 2009

Recently, GlobalSubmit CEO Rahul Mistry arranged a meeting with the Mayor of Philadelphia, Mayor Michael Nutter, and 15 other CEOs with whom Mistry meets monthly. As is the case with every major city in the US, Philadelphia is experiencing the effects of the economic downturn. During this meeting, Mayor Nutter addressed this issue and expressed his sincere gratitude for companies remaining in Philadelphia during these difficult times. He also asked that businesses remain patient as Philadelphia undergoes numerous changes. When asked about the meeting, Mistry stated, "What stood out to me about Mayor Nutter is that he runs Philadelphia as if it were a business, including making responsible decisions -- even if they are difficult -- with an end goal of ensuring the long-term health of the city." As GlobalSubmit continues to innovate and grow, we are happy to contribute to the future prosperity of our home in Philadelphia. Click here to see Mistry's meeting with Mayor Michael Nutter. For those of you who don’t know Rahul Mistry, he is the gentleman with the glasses directly to the Mayor’s right.

GlobalSubmit Continues Expansion: Signs New Agreements with FDA and Life Sciences Companies - Thursday, September 03, 2009

GlobalSubmit Inc. announces that it is experiencing significant growth moving into 4Q ‘09 and that it expects continued growth in 2010.

Rahul Mistry, CEO, says that the company’s continued success results from its relationship with the FDA, its commitment to delivering the highest quality products and services to customers and its talented, hardworking team. States Mistry, “GlobalSubmit experienced 20% growth over the last six months and recently completed its highest sales quarter ever. We’ve added numerous in-house resources and had to double our office space to accommodate our growth. We’re one of the few companies out there that’s still growing, and growing quite rapidly in spite of current economic conditions.

Since May 2009, GlobalSubmit signed three important agreements with the FDA:

· May, 2009 – Company signs Cooperative Research and Development Agreement (CRADA) with FDA. Agreement states that GlobalSubmit will develop software that allows FDA to view, analyze and compare study design information in a unified view.

· July, 2009 – Company signs three-year Maintenance and Support Agreement with FDA. Per the agreement, GlobalSubmit will enhance and/or upgrade the GlobalSubmit REVIEW™ and VALIDATE™ software products already in use at the Agency.

· August, 2009 –GlobalSubmit and FDA kick off project focused on developing prototype that loads HL7 messages into Janus Version 2 database and exports those messages in a Study Data Tabulation Model (SDTM) file format.

In addition to these agreements, GlobalSubmit signed nine new Life Sciences customers since January 2009 and has had over 95% of its current customers renew their agreements. Because of the submission quality assurance provided by GlobalSubmit software, the company’s solutions are used by over 60 pharmaceutical companies, including half of the top 20 pharmas.

Moving forward, the company expects to see much more of the same. Says Mistry, “We offer software solutions to the FDA and to Life Sciences companies that make reviewing and validating regulatory electronic submissions an intuitive process. Reviewers on both sides of the equation see data in the same format and can navigate it quickly and easily. That sets us apart in our market space. And because our team consists of the industry’s top thought leaders, strategic business minds, and extremely creative and talented developers, the 2010 release of our REVIEW™ and VALIDATE™ products promises to bring an even higher level of success and growth to GlobalSubmit.”

FDA and GlobalSubmit Pilot Prototype Software for Loading HL7 Messages into Janus Version 2 Database - Tuesday, August 18, 2009

GlobalSubmit announces that it recently kicked off a project focused on developing a prototype that loads HL7 messages into a Janus Version 2 database and exports those messages in a Study Data Tabulation Model (SDTM) file format. GlobalSubmit is close to completing the development of that prototype, but went a step further by extending the model so that it will load and export both SDTM and HL7 files. Recently, GlobalSubmit and FDA began the actual testing of these solutions by reviewing HL7 Study Design, Study Participation and Subject Data.

In late July, GlobalSubmit met with the National Center for Toxicological Research (NCTR) at its offices in Jefferson, Arkansas. While there, GlobalSubmit installed the prototype Janus Version 2 database. GlobalSubmit also reviewed the Study Design prototype, which, when in production, will expedite the protocol review process. That prototype runs seamlessly “on top of” the Janus prototype database.

During the pilot period, FDA will receive data in a standard HL7 format and load that data into its prototype Janus Version 2 database. In addition to the Janus Version 2 database, FDA will also make use of enhanced analytical, mathematical, visualization and other computational tools and techniques that enable reviewers to search, model, and analyze data to conduct better safety and efficacy analyses. If the pilot is successful, GlobalSubmit anticipates that within two years, these new HL7 standards will become the preferred method of exchanging study information with the FDA.

FDA Signs Three-Year Maintenance and Support Agreement with GlobalSubmit - Tuesday, July 07, 2009

Per our latest agreement with the FDA, GlobalSubmit will enhance and/or upgrade the REVIEW™ and VALIDATE™ products already in use at the Agency.