Sitrof Safety Capture imports all adverse event (AE) source data regardless of original format-paper, digital, fax, e-fax, email (with or without attachments)-as well as voice records from call centers--into Oracle Argus and other adverse event/safety management systems.

"It has become a pharmaceutical imperative to "unlock" AE source documents for scaling global operation and managing CROs," says Bryan Reynolds, co-founder and managing partner of Sitrof. "We were able to develop a product, powered by EMC's InputAccel, that transforms unstructured AE source documentation into searchable digital records and automatically create entries in your AE system."

Sitrof Safety Capture improves your company's end-to-end pharmacovigilance program by providing a holistic view of product stewardship-from clinical trials through post-marketing surveillance, by automatically creating entries in the Argus Intake Worklist. From the Intake Worklist, users have the ability to create a case from the source documentation or reject the document.

At the Summit, industry experts will take an in-depth look into how the latest technologies are being used today to solve critical business issues within the Life Sciences industry.

The event will include a continental breakfast for all attendees followed by opening remarks and three breakout sessions.

• Electronic Trial Master File: The session will focus on leveraging intelligent capture to automate the way documents and data are captured globally in an eTMF.
• Safety Reporting: Leverage intelligent document capture to improve pharmacovigilance and integrate with leading safety systems.
• Records Management: Leveraging technology to maintain critical electronic and paper based information. See how actual retention policies and procedures combine with technology to reduce the cost and risk associated with information governance.

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Agenda

Location

The Olde Mill Inn
225 Route 202
Basking Ridge, NJ 07920
908-221-1100

Sitrof migrates a company’s data, content and metadata--no matter how many repositories they have or need. And Sitrof guarantees that all migrations are performed successfully through strict validation requirements.

"Migrations are become a necessity based on the number of mergers and acquisitions taking place," said Bryan Reynolds, Managing Partner of Sitrof Technologies. "The fixed-price aspect means there are no surprises and budgets stay on track. Additionally, we are partnered with a variety of migration specialists and developed our own custom tools to make it the most efficient migration possible."

Practical expertise means Sitrof takes the risk out of system consolidation. For over a decade, Sitrof has performed complex migrations for Fortune 100 companies, successfully migrating content from a variety of sources to different target repositories in the Life Sciences and other highly regulated industries.

Fixed-Price Migration consolidates data, making the business more efficient. Additionally, Fixed-Price Migration is tailored to the client: a Sitrof Migration Analyst works through the Migration Checklist and delivers a plan. From there, it can be done on-site or off-site based on the business’ needs and cost requirements. For regulated and non-regulated environments alike, Sitrof is the trusted provider for complex content migrations.

For more information on Sitrof Fixed-Price Migration, click here.

About Sitrof Technologies
Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof please visit http://sitrof.com

The panel will discuss topics around capture, store, share and control within ECM, focusing on going paperless. Attendees will be provided with recommendations, best practices and challenges that businesses and organizations face when trying to move to a paperless environment.

"Sitrof has led a number of paperless initiatives in highly regulated industries," said Reynolds. "I’m looking forward to speaking about the numerous benefits of going paperless, as well as the challenges involved."

The AIIM Garden State Chapter panel event will be on Tuesday, May 10 at the Woodbridge Hilton in Iselin, NJ. The event starts with a networking session at 5:30pm. Click here to learn more or to register.

About Sitrof
Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof email sales@sitrof.com.

Reynolds’ speaking session will explore the need for federation and localization as a means of keeping businesses competitive and compliant in today’s global marketplace. It is open to all attendees of the AIIM Conference and Expo. Attendees will learn how to bring unstructured data under control and ensuring it is secure, compliant and auditable and easy to locate, and why adding localization is critical to successful federation of content.

Reynolds’ talk is at 2:40pm on March 22 in the Walter E. Washington Convention Center in Washington, DC. The AIIM Conference and Expo @info360 is the world’s largest annual event serving the content and information management space.

For more information about the AIIM Conference and Expo, please click here.

About Sitrof
Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof please visit http://sitrof.com.

Please come visit Sitrof at DIA EDM in booth #205 to see how Approve-PTS can work for you.

Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible. Jobs are routed via built-in workflows with annotations and version control to retain full audit trail.

“We developed Approve-PTS for a pharmaceutical company to reduce the time needed to circulate, review and approve promotional materials and maintain compliance,” says Bryan Reynolds, co-founder and managing partner of Sitrof. “There is a tremendous need for this product and building it on SharePoint 2010 has been key to quickly launching solutions in a timely fashion.”

Approve-PTS reduces previously untrackable delays and logjams. Reviewers are notified via email that a job is waiting their review. Digital signatures with automatic date and time stamp ensure 21 CFR Part 11 compliance. In addition, advanced reporting tools allow marketing communication specialists and administrators to collect thorough metrics to resolve delays and improve the process.

About Sitrof

Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof or Approve-PTS please visit http://sitrof.com

About DIA EDM

For 23 years, DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s show will focus on The Intersection of Data, Documents and Submissions.

Media Contact:
Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

Sitrof Technologies is pleased announced the end customer, Copernicus Group IRB (CGIRB) was named a finalist for the 2011 AIIM Best Practices Award. The Carl E. Nelson Best Practices Award was established to recognize excellence in information management.

Sitrof Technologies implementation of Xerox Corporation’s DocuShare® enterprise content management (ECM) was recognized as a finalist in the Small Company category for their work in transforming Copernicus Group IRB into a paperless company. CGIRB is now 96% paperless after the 2 year implementation. The paperless endeavor involved a massive legacy document scanning operation, including 1.5 million legacy documents totaling 5 million pages, as well as all internal documents and all inbound paper and electronic documents. Utilizing the Sitrof Compliance Module for DocuShare, CGIRB is able to maintaining FDA 21 CFR Part 11 compliance.

“We are excited to be a finalist,” said Bryan Reynolds, Managing Partner of Sitrof Technologies. “This was a huge undertaking requiring a lot of time and resources. The success of the project was due in a great part to the multi-phase plan developed by CGIRB’s director of IT, Jennifer Sodrel. Internal change management can sometimes be the most difficult part of a paperless implementation and Jennifer nailed it.”

"The quality of the submissions for the Carl E. Nelson Best Practice Award continues to improve raising the bar on best practices while emphasizing innovation, benefits and lessons learned," said John Mancini, President, AIIM. "Our AIIM Emerging Technology Advisory Group (EmTAG) selected the finalists in each category for the Best Practices Award. Our professional members are determining the winner in each category. Each of the finalists share many valuable lessons learned to help others with their implementations.”

AIIM professional members will chose the winner from the finalists. Award winners will be announced at the AIIM Annual Awards Celebration, March 22 at The W Washington, DC, where John Mancini, AIIM’s President, will announce the winner.

About Sitrof Technologies

Founded in 1999, Sitrof Technologies provides a new breed of information management, data protection and compliance solutions. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk.

To learn more email sales@sitrof.com or call 866-545-8954.

Media Contact:

Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

Princeton, NJ, January 21, 2011- Sitrof Technologies, a company that provides premier consulting and technology solutions, announced today that they will be attending the DIA Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Conference (DIA EDM).

DIA EDM will take place in National Harbor, MD from February 15-17, 2011. The Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Please come visit Sitrof at booth #205, as we have some exciting new offerings to make document management and compliance a snap.

"We are excited to have the opportunity to attend this year’s conference," says Bryan Reynolds, managing partner and co-founder of Sitrof Technologies. “Stay tuned for an announcement of a new offering for life sciences to streamline the management of marketing and promotional materials.”

About Sitrof

Founded in 1999, Sitrof Technologies is a privately held profitable company with headquarters in Princeton, NJ, and offices in San Francisco and London. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk. To learn more visit http://www.Sitrof.com, email sales@sitrof.com or call 866-545-8954.

About DIA EDM

Over the past 23 years, DIA EDM strives to teach participants to recognize the challenges and complexities of globally managing information, explain the importance of aligning standards, technology and leveraging interoperability, recognize the vital role of metadata in the intelligent management of data, documents and submissions as well as identify trends and standards in electronic records. To learn more about DIA EDM visit http://www.diahome.org/DIAHome/Home.aspx.

The article spotlights Copernicus Group IRB (CGIRB), a client who Sitrof turned paperless in a large-scale project. “One company – Copernicus Group IRB – comes closer to epitomizing ‘the paperless office’ in the truest sense of the term than any other company I’ve written about during my seven years covering the ECM space,”  wrote Ken Congdon in the article.CGIRB was looking to become paperless and chose Sitrof to spearhead the project. The list of needs from CGIRB included compliance, electronic workflow, version control and digital signatures to eliminate the need to print and circulate hard copy documents. Sitrof delivered and worked closely with CGIRB over a two-year period to help them become paperless. This included scanning nearly 1.5 million legacy documents totaling 5 million pages, which was part of a three-phased approach to implement the new solution, Xerox DocuShare and the Sitrof Compliance Model.

To read the full article in ECM Connections, click here.

Together they transformed CGIRB from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization. CGIRB chose Sitrof to handle this project because of Sitrof's specialty in unstructured data management and extensive experience in FDA 21 CFR Part 11 compliance. Sitrof installed Xerox DocuShare and the Sitrof Compliance Module to automate the workflow and decision process; to improve efficiencies and customer service; all while remaining compliant. The benefits of going paperless have been numerous for CGIRB and the clinical trial sponsors they work with on a daily basis. Most notably, the solution, which ties into CGIRB’s proprietary Protocol Tracking System (PTS) has sped up their review process and given clients real time access to status and documentation through an enhanced web portal, Connexus. The article, which notes CGIRB's large donation of paperclips to local schools, also touches on CGIRB's evolution as a greener, more efficient company.

"Taming the Beast," is in the November-December 2010 issue of Bio IT World and can be read online here.

The full Copernicus Group IRB Case Study can be read here.