Prior to the founding of the Alliance of Experts, life science customers either employed a range of specialized tools from several different domain specialists to meet RIM requirements which may not work together or purchased a single solution RIM enterprise tool that provided limited depth of expertise in the rapidly changing life science market. The Alliance of Experts offers the best of both worlds by providing expert, established applications and guaranteeing the integrations between them with a single Alliance support service. This approach removes the burden of maintenance and risk from our customers, while ensuring zero compromise on functionality.
A prime example of an effective RIM solution provided by the Alliance of Experts is the Submission Archiving function. Leveraging the integration between LORENZ docuBridge and Generis' CARA, Submission Archiving pushes an archive copy of the published submission into CARA for long term storage, while creating an application sequence in docuBridge that includes leaf nodes pointing to the relevant files in CARA. Archived submissions can be accessed from CARA or from docuBridge with equal ease, giving customers exactly the same view of the submission that the agency has, along with links to the source files of their published equivalents.
"The whole point of the Alliance of Experts is efficiency," says James Kelleher, CEO at Generis, "and this means that customers benefit directly from having a single source of regulatory data that can feed many different processes. This means that the sheer number of sources of error are greatly reduced."
Karen Roy, Chief Strategy Officer from Phlexglobal echoes the sentiment: "Combining our Clinical expertise with the Alliance's Regulatory Affairs expertise really creates a whole new user experience. Customers can assemble their own perfect solution from a range of different partial ones."
"The Alliance of Experts combines the advantages of a single RIM vendor and at the same time overcomes the limitations of a single RIM vendor," says Raoul Lorenz, CEO of LORENZ Life Sciences Group, "Through 'automated integration' we are taking the headache out of system integration, and are able to offer more variety and much deeper functionality. This is a marked step forward from both the classic approaches as well as the rigid platforms that have tried to replace them."
For more information of how the Alliance of Experts has created agile, tailored, end-to-end solutions to help customers, check out the joint initiative's website.
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia that enable compliance enforcement globally. LORENZ' tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes, allow LORENZ customers to enhance operational efficiencies. With over 1050 paid installations in 38 countries, LORENZ has a strong worldwide customer base.
About Generis Knowledge Management
Generis has been providing leading-edge software for content management systems including Documentum, SharePoint, Alfresco and Oracle WebCenter since 1997. The company has more than 50 customers across industries from Federal Government, through Life Sciences and Engineering to Media, Publishing and Financial. The company is headquartered in Sarasota, FL, and has its principal development centers in Europe. Customers include 8 of the global top 10 Life Science companies, Federal and State governments, engineering and media companies. For more information about Generis visit www.generiscorp.com
Phlexglobal are world renowned thought leaders and specialists in the provision of electronic Trial Master File (eTMF) systems and services. They offer a unique combination of eTMF technology with PhlexTMF – their market leading eTMF system, quality services and specialist resource that delivers a range of flexible, targeted solutions to meet your business needs. Phlexglobal is headquartered in the UK, with offices in Malvern, PA and Lublin, Poland.