News and Events
ArborSys to Attend the DIA Regulatory Submissions, Information, and Document Management Forum - Booth #103
Feb. 11-13, at the Bathesda North Marriot Hotel and Conference Center, North Bathesda, MD
The DIA forum focuses on:
- Electronic Regulatory Submissions (ERS) - the submission process including updates to regulations and industry adoption techniques.
- Electronic Document Management (EDM) - processes, systems, and best practices for content management across the product life cycle.
- RIM Technology and Business track - tools, system approaches such as MDM, processes across both industry and regulators, and the standards as they apply to data and regulatory activities
Please join us to meet our team and see our solutions using the innovative cloud-first productivity platform, InteliNotion.
ArborSys Presented at the 22nd Annual Merck Technology Symposium, Booth #613
September 5-6, 2018, at the Ocean Place Resort and Spa, Long Branch, NJ
The Merck Technology Symposium brings R&D leaders and influencers in Merck’s scientific and business worlds together, along with key suppliers, to enable the sharing of ideas across the business. Innovation occurs when people are open to new ideas, when they can “see” with fresh eyes and are willing to move forward at a rapid rate. That is what the Merck Technology Symposium is all about.
This year’s symposium theme centers on
Improving Lives through Collaborative Innovation & Technology.
Learn more about how we facilitate collaboration and innovation at the intersection of Business and Technology.
ArborSys Presented at DIA Global Annual Meeting 2018: Generating Narratives Using Structured Content Principles presented at the 22nd Annual Merck Technology Symposium, Booth #613
ArborSys Partner and Practice Director of Document and Content Management, Shailesh Shah, co-presented at the DIA Global Annual Meeting, on June 26, 2018 in Boston, MA. Co-presenting with Shailesh was a client from the Clinical Operations group at a global pharmaceutical company, on a topic titled “Generating Narratives Using Structured Content Principles”. The session described a client implementation of narratives using Structured Content Management (SCM) tools and principles. This session was one of three sessions covered as part of “Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications” track.
Download the presentation slides [PDF opens in new window]
ArborSys Presented at the ExL Events 4th Annual Clinical Regulatory Medical Writing Forum
ArborSys Partner and Practice Director of Document and Content Management, Shailesh Shah, co-presented at ExL Events 4th Annual Clinical Regulatory Medical Writing Forum, on July 10-11, 2017 in Philadelphia, PA. Co-presenting with Shailesh was a client from the Clinical Operations group at a global pharmaceutical company, on a topic titled “Structured Content and Information Design that Maintains Consistency and Turns Content into Data”. ArborSys was also an event sponsor. More details can be found at the Events.
ArborSys Presented at the 2017 Annual American Medical Writers Association Conference
ArborSys Practice Director of Structured Content Management, Angela Horowitz, co-presented at 2017’s Annual American Medical Writers Association (AMWA) Medical Writing & Communication Conference, November 1st through 4th, in Lake Buena Vista, FL. Co-presenting with Angela was a client from the Clinical Operations group at a global pharmaceutical company, on topic titled “Realizing the Benefits of Structured Content Management in a Step-wise Fashion”. In addition, Angela collaborated on a poster presentation titled “Use of Standards and Automation to Deliver Cost-Effective Patient Narratives” with another client from the Medical Writing group at the same company. More details can be found at the Conference.
ArborSys Attends the 5th Annual Merck Digital Innovation Summit 2015
October 6-7, 2015 Garden State Exhibit Center, Somerset, NJ
The 5th Annual Merck Digital IT Summit, was a global, corporate-wide event to address a range of issues in the IT and Data space (e.g., Analytics, Security, and Performance). The Summit brought 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 Suppliers/Exhibitors, Internal Booths representing major Divisions within the company, and a Pavilion of cutting edge Startup companies. The 2015 Summit theme was Exchanging Ideas that Advance Healthcare.
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 Presents at a Pharma Labeling Compliance Conference
Dr. Michael Brennan, Director at the ArborSys Group, spoke at the Third Annual Pharma Labeling Compliance Conference in Cambridge, MA on March 25, 2015. His talk, Management of Labeling within an Integrated Structured Content Management System, covered:
- 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 Attends 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 a 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 Exhibited at Merck's Digital Tech Innovation Summit 2014
ArborSys had a booth at the 4th Annual Merck Digital Innovation Summit on October 14-15, 2014. The event was held at the Garden State Exhibitor Center in Somerset, NJ. The summit focused on key business initiatives such as pipeline maximization, product launch excellence, customer centricity, and analytics. Over 5,000 technologists, innovators and professionals participated, both in-person and virtually. Attendees from multiple business units along with key technology suppliers interacted and focused on the evolving landscape of healthcare and finding joint solutions to current problems. The summit featured 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 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.
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]