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Intelligent Regulatory Information Management (RIM)
offered by an alliance of established experts.

Replace replication with communication

Who we are

generis

Generis is a leading provider of content and information management software CARA, with 8 of the global top 10 largest Life Science companies as clients using CARA for a wide variety of RIM use cases enterprise-wide, with over 400,000 licensed users worldwide.

lorenz

LORENZ Life Sciences Group 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 which enable enforcing compliance globally.

phlex-1

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 PhlexEview – their market leading eTMF system, quality services and specialist resource that delivers a range of flexible, targeted solutions to meet your business needs.

dossplorer

Dossplorer is developed by Qdossier, widely recognized as a leading international regulatory services- and consultancy company. Qdossier supports clients in implementing lean and unified end2end regulated business processes and is still with the ‘feet in the dirt’ when supporting companies with their daily document- and submission management. Dossplorer allows individuals to share, compare and view eCTDs, NEES’ and other dossier formats in a single interface. This capability adds significant value to traditional viewing methods (often limited to eCTD only) and has been welcomed by the Life Science regulatory community. The integration with CARA, Generis’ industry-leading user interface for Documentum, allows CARA users to easily view dossiers directly from their Documentum repository. Not only can regulatory specialists view dossiers, they can also organize documents and dossiers by consolidating information from multiple products, -countries and regulatory activities, resulting in a and personalized view which is ‘fit-for-purpose’.

What we do

The member companies of the Alliance of Experts provide solutions that cover the Life Sciences RIM (Regulatory Information Management) landscape.

The members provide certified deep integrations of their tools to ensure seamless data flow and a single-source-of-truth on all regulatory data while allowing easy reuse in multiple places.

The Alliance of Experts allows clients to elect for single contracts and single support structure. The software is offered inhouse, in the cloud, or as a hybrid, based on the client preferences.

Use Cases

The Alliance of Experts brings together expert, business-niche driven businesses with track records in their areas of expertise. Their functionally rich systems integrate seamlessly – invisible to the user’s eye – providing you with a Family of Apps that communicate. Backed by Gartner’s analysis that a single Enterprise tool is a thing of the past. Efficiency is a key target of the Alliance. The founding partners of the Alliance of Experts extend across the enterprise including the core areas of clinical, regulatory operations, quality, and regulatory submissions bringing you clear opportunities for time saving and quality gain.

Use Case: The Protocol and Amendments

Usually generated internally within a document management system, the Protocol and Amendments sit at the heart of any Clinical Trial. Access to the Protocol and Amendments is required by the entire Clinical Team and the Submission. Starting life in Generis’s CARA for collaborative authoring and approval, the final version will be pushed to PhlexEview eTMF to allow visibility to the Clinical Team, even those who do not have access to CARA. Any Amendments follow the same path, with finalisation in CARA triggering an automated push to PhlexEview. Time for a submission? LORENZ’s docuBridge pulls together links to the Protocol and Amendment to seamlessly create a regulatory submission package. The metadata for all the systems is synchronized to ensure a single source of truth.

Use Case: Study Reports

Study reports (clinical study report, statistical report, and bioanalytical report) are created within CARA. Whilst they form a part of the TMF, stand alone copies are not required and therefore a link is created within PhlexEview to facilitate viewing by the relevant Clinical Team members. At submission time, docuBridge pulls together links to the Protocol and Amendment to become part of a submission with traceability from the source file to the submitted file across submissions in different markets.

Use Case: Principal Investigator CVs

PI CVs create an ongoing challenge for Regulatory Submissions. Created outside of the Sponsor / CRO environment, they are uploaded to PhlexEview. Utilising the completeness tracking, missing CVs are easily highlighted to be tracked down. This makes for an easy submission, links from PhlexEview to docuBridge means that the CVs can be pulled effortlessly with assurance that they are all present.

Use Case: Submission Archiving

Leveraging the integration between docuBridge and CARA, the Submission Archiving functionality pushes an archive copy of the published submission into CARA for long term storage while creating an application sequence in docuBridge with leafs that point to the files in CARA. Archived submissions can be accessed from CARA or from docuBridge with equal ease giving you the same view of the submission that the agency has and linking the source files to their published equivalents.

Systems Implemented

R&D / Regulatory Submissions / eCTD

R&D / Regulatory Submissions / eCTD

Standard data structure and metadata based on the DIA Reference Model for handling submission documents of all kinds including publishing and eCTD viewing.

GxP / SOP / Quality

GxP / SOP / Quality

Standard data structure and metadata based on the DIA Reference Model for SOPs and other Quality documents including controlled printing, full lifecycle and workflows and a viewing portal.

eTMF

eTMF

Standard data structure based on the DIA Reference Model for Electronic Trial Master File documents, including new site handling, reporting (missing documents etc.) and integration with multiple CTMS systems and an Investigator Portal.

Labelling

Labelling

Full label lifecycle from Core Data Sheet through translations to branch versioning per country and Health Authority approval management. Structured content authoring and print shop portal.

Pharmacovigilance

Pharmacovigilance

Integrate seamlessly with ARGUS or ARISg for case management with content securely stored and versioned in CARA.

Safety Data Exchange Agreements

Safety Data Exchange Agreements

Store and track Safety Data Exchange Agreements (SDEA) with contract expiration workflows and automatic single button generation of PSMF Annexes for submissions.

Medical Information

Medical Information

Deal with incoming Medical Information requests via call centers, emails and more. Real time searching for answers, including automatic sending, and full per-country data privacy handling.

LIMS

LIMS

Document handling optimised for clean-room conditions on mobile devices, including QR code usage and easy form filling to generate dynamic PDFs.

Medical Devices

Medical Devices

DIA Reference Model-based data structure and management of Design History Files (DHF), Device Master Records (DMR) and Device History Records (DHR).

Sales & marketing

Sales & marketing

Leverage submitted labelling and manage the associated sales and marketing documentation, including videos (with built in preview and annotation) and artwork.

Corporate (IT, Legal, HR)

Corporate (IT, Legal, HR)

Full set of standard templates and data structure for IT project documentation, contract / legal functionality such as document comparison and review / portal sharing, and Human Resources files.

IDMP

IDMP

Data management through CARA integrated with your content management to provide IDMP functionality integrated with other solutions in the RIM space.

Regulatory Correspondence

Regulatory Correspondence

Automate capture of incoming correspondence via the CARA Staging area, including email attachment extraction. Link to Dossiers and prepare and relate answers and commitments.

Submission Planning & Tracking

Submission Planning & Tracking

Build dossiers from planning sheets, Excel export lists or third party tools, and then track the progress, including metrics from one submission to the next for process improvement.

PSURs / Educational Materials

PSURs / Educational Materials

Manage the dissemination of PSURs to affiliates and partners, along with Educational Materials, and track the progress of reporting to local agencies.

RIM

RIM

Combine one or more of the CARA solutions, and/or integrate with existing tools to make CARA the RIM portal for your enterprise.

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