News and Events
ArborSys Wins Microsoft Life Sciences Innovation Award
ArborSys Group was chosen as a winner of Microsoft Corp.'s 2012 Life Sciences Innovation Awards. The award recognizes the ArborSys contribution to a business process and software solution that is helping our client, a global and diversified healthcare leader, to more rapidly and efficiently produce clinical documentation deliverables, with uncompromised compliance, consistency, and quality. Our client and another Microsoft partner also received awards for this innovative project.
ArborSys provided consulting services for Structured Content Management (SCM) and Topic Based Authoring (TBA) in the design of a leading-edge content management solution that includes processes, tools, and services built on Microsoft technologies. ArborSys also provided development, testing, and change management/communications expertise.
The Structured Content Management platform includes the Microsoft Intelligent Content Framework for regulated industries. The company’s solution addressed one part of the documentation compendium, the creation of patient narratives, which summarize patient results in a clinical study. The solution saved the company 22,000 hours of work on 4,000 documents from initial deployments.
Click on the award picture for a larger view.
Meet ArborSys at booth #504 at the 5th Annual Merck Global IT Summit 2015
October 6-7, at the 2015 Garden State Exhibit Center, Somerset, New Jersey
The 5th Annual Merck Global IT Symposium, part of the Merck Tech Innovation Summit, is a global corporate wide Congress to address a range of issues in the IT and Data space (e.g., Analytics, Security, and Performance). The Summit will bring together over 3,000 technologists, innovators and professionals from across all areas of Merck (e.g., Research, Development, Manufacturing, Sales, IT, Finance, HR), as well Supplier/Exhibitors, Internal Booths representing major Divisions within the company, and a Pavilion of cutting edge Startup companies. This year’s Summit theme is Exchanging Ideas that Advance Healthcare.
The Summit will feature engaging speakers, insightful discussions with thought leaders and demonstrations of technology – all intended to drive innovative thinking around how information technology can help improve healthcare as we know it!
Learn more about how we facilitate collaboration and innovation at the intersection of Business and Technology.
ArborSys Presents Regulatory Compliance Webinar
ArborSys held a Regulatory Compliance webinar, The Art of What's Possible - A Process Driven Approach, on May 21, 2015.
Click the image to the right to watch the webinar recording.
ArborSys Thought Leader to Present at a Pharma Labeling Compliance Conference
Dr. Michael Brennan, Director at the ArborSys Group, will be speaking at the third Annual Pharma Labeling Compliance Conference in Cambridge, Massachusetts on March 25, 2015. His talk, Management of Labeling within an Integrated Structured Content Management System will cover:
- Approaching labeling from a broader view
- Designing a labeling application that is integrated with structured authoring and supports the broader product development documentation – e.g. clinical documentation, chemist, manufacturing, and non-clinical documentation
- Implementing an application that will not present a technical barrier and allow easier access for a diverse set of users
Michael has held senior leadership roles in Global Regulatory Affairs Operations, Regulatory Affairs, and Clinical Operations. Michael serves on the steering committee of the FDA/PhUSE Computational Science Symposium.
Over the past 4 years, Michael has been actively engaged in driving the transition to structured authoring. Michael has also been very active on HL7 RCRIM team with FDA that has explored and tested different approaches that would allow clinical information to be created and submitted in a structured XML form (e.g., Form 1572, patient narratives, and clinical protocol). Michael has been working with the Transcelerate team that is tasked with developing a functional common protocol template that is both human and machine-readable.
Dr. Michael Brennan to attend PhUSE Working Group Steering Committee Meeting, March 15-17, 2015
The mission of the PhUSE organization is to provide an open, transparent and collaborative forum in which Academia, Regulators, Industry and Technology providers can address computational science needs in support of health product development and regulatory review.
The Collaboration promotes the following goals:
- To facilitate discussions among regulatory agencies, industry, and other stakeholders that inform and improve computational science to support product development and review
- To bring together experts in specific areas to collaborate on computational science, describe best practices in challenging areas, and propose methods for addressing knowledge gaps
- To support ongoing collaborative working and project groups throughout the year by aligning working group objectives, reviewing project requests and deliverables, and providing direction for project issues and gaps
- To establish an infrastructure and operational processes to support the collaboration
Dr. Michael Brennan, Director, Regulatory Compliance, at ArborSys, is a member of the PhUSE/CSS Steering committee.
Mike Liscovitz, Managing Director at ArborSys, was featured in an interview in the October 2014 issue of Prime magazine
As part of an feature article on Innovation through Collaboration, Mike was interviewed and discussed how collaboration has become an increasingly prominent point of focus in the life sciences industry. Click on the thumbnail below to download a PDF copy of the article and Mike's interview. To download the entire issue, click on the cover thumbnail below.
ArborSys Exhibiting at Merck Tech Innovation Summit
ArborSys will have a booth at the 4th Annual Merck Tech Innovation Summit on October 14th and 15th. This event will be held at the Garden State Exhibitor Center in Somerset, New Jersey. The summit will focus on key business initiatives such as pipeline maximization, product launch excellence, customer centricity, and analytics. Over 5,000 technologists, innovators and professionals will participate, both in-person and virtually. Attendees from multiple business units along with key technology suppliers will interact and focus on the evolving landscape of healthcare and finding joint solutions to current problems. The summit will feature engaging speakers, insightful discussions with thought leaders and demonstrations of technology – all intended to drive innovative thinking around how information technology can help improve healthcare as we know it!
Shailesh Shah, ArborSys Electronic Content Management Practice Director, speaks at Global Labeling 2014: Compliance in a Changing Regulatory Environment
Shailesh filled in for the scheduled speaker, Ole Andersen, CEO of DitaExchange, at this DIA conference on April 9, 2014. Shailesh was one of three speakers on the topic, From Labeling (Global and Local) Through Dossier Content Using XML - Extending the Value of Structured Content Management and Reuse. The session presented opportunities on how XML and DITA (Darwin Information Typing Architecture ) are being used to link and reuse content from the CCDS to local labels and to link to parts of dossier. The use of XML is not new for labeling and eCTD, but this is a new way of working to extend the use of XML/DITA to link the CCDS (or local labeling text) directly into the supporting documents, for example, the clinical documents. The XML/DITA tool has been implemented in use in clinical documentation, narratives, protocols, biostatistics, SAP, and global labeling. This was discussed from labeling point of view and also from XML and DITA expert point of view describing opportunities and solutions.
Download the presentation slides [PDF opens in new window]
ArborSys Announces ArborSys EU
With many clients having a global presence with facilities and resources overseas, ArborSys Group has established a European subsidiary, ArborSys EU. As an extension of our global team, local ArborSys EU staff are better positioned to deliver business value, empower our clients, and promote global team excellence. ArborSys people bring a balance of discipline, creativity, perspective, and focus to make a difference for our clients. For more information contact us.
ArborSys Sponsors and Presents at the Process Excellence & Lean Six Sigma for Pharma at Process Excellence Network Conference
ArborSys was one of the sponsors of the Process Excellence & Lean Six Sigma for Pharma conference held in Philadelphia, PA in October 2013. Vasu Ranganathan, ArborSys Partner, was one of the presenters of a program on Clinical Process Optimization and Automation. Co-presenters included representatives from the client project team and Appian
Download the conference presentation [PDF opens in a new window]
ArborSys Presents "The Power of Content Reuse Within Clinical and Labeling Documentation" at DIA Conference
Shailesh Shah, Electronic Content Management Practice Director, presented at the EDM and ERS/eCTD: Impact on Content and Context conference held in San Diego, CA on October 15-17, 2013. The conference served as a forum for the discussion of emerging standards and the processes for submission, creation, and maximum use of regulatory information. The combined EDM and ERS/eCTD explored the information generated along the drug development continuum lifecycle and alignment to ever evolving regulatory and electronic standards. The pace of global electronic initiatives necessitates industry to continually assess internal processes to maximize content reuse and streamline efforts by pushing submission-ready and data standards farther upstream. As technologies and standards progress along with the real-time increasing volume of information generation, the complexities and challenges of data sharing and also data protection are becoming ever more apparent. Advances in technology, standards, and evolving regulations will continue to impact documents along their lifecycle.
Download Shailesh's presentation [PDF PowerPoint opens in new window]
ArborSys Joins Microsoft and Their Partners to Develop the Intelligent Content Framework Solution
ArborSys has established a partnership with Microsoft and key partners to design and build a Structured Authoring solution for regulated industries to accelerate the Study Design and Regulatory Documentation Development processes. The solution was presented at the 2011 DIA conference
Download the White Paper [PDF opens in a new window]