Presented by Jennifer Wemstorm – Senior Director, Product Management and Jessica Kelley, Quality Product Management. Attendance was only about 40 but could be because of the 8:30 start time. This post will present our thoughts on the Roadmap.
Life Science – Solution or Product?
As we posted last year, the life science solution appears to have the most investment, focus and has benefited from a consistent vision focused on D2. Both Jennifer and Jessica come from distinguished Life Science backgrounds. Both come from CSC, Jessica also comes from Sparta. TSG has known Jennifer since back in the early 90’s as she was beginning her career at life science companies.
Unlike solutions in the past, Life Sciences (along with Asset Operations) has a clear roadmap including the current 3.1 release:
- Documentum/D2 Platform – Underlying Platform
- Lifecycles and Workflow, Security Models, Property Registration, Compliance Features
- DIA and Industry Standard Document and Data Inventory
- Clinical – eTrial Master File
- Research and Development – Nonclinical, Clinical and Safety, Quality, Regulatory and Labeling
- Submission Store and View – Regulatory Submissions, Regulatory Correspondence
- Quality – Quality and Manufacturing – Procedural, Manufacturing, Quality, Change Request
A Unified Solution Layer allows the Clinical, R&D, Submission and Quality to either be implemented independently or together. Solution also includes support for common data model and enterprise content model. We thought the vision of a consistent data model under all of the Clinical, R&D, Submission and Quality was well thought out and had been co-developed with major clients.
The 4.0 release includes the following updates:
- Support for D2 4.5 Technical Refresh
- ETMF – Investigator Workspace gives clinicians direct access to eTMG
- ETMF – Investigators can select their site, upload missing documents, and view key documents. They can also participate in workflow
- R&D – Data Model Relationship Enhancements – invested a lot for the data model.
- R&D – OOTB Clinical Study Report Virtual Document Template
- R&D – Support for Submission Management
- R&D – Support for Regulatory Activity Grouping
- Submission – Registration Form
- Submission – Regulatory Activity Package Management
- Submission – The ability to launch to Viewer to an individual submission
- Submission – Ability to compare two documents side by side in new Compare document workspace
- Quality – OOB Best Practice Document and Data Inventory
The feature I thought was impressive was the Enhanced Collaboration Editing that comes with D2 4.5. In the past, clients have integrated with SharePoint or Please Review to allows clients to work on the document at the same time. Collaborative editing is being added directly in the platform from Microsoft Word. Users can see others changes while others are seeing them. Example given – if one person in the document they need to save but second person has to do a manual refresh. Will look to add a post with more of a demo later in D2.
Life Sciences and “Trust” of Documentum
While we were impressed with the Product Roadmap, most Life Sciences clients we talk to are hesitant to “jump back in” with Documentum due to a number of “do I trust Documentum” reasons including:
- Difficulties in the past with Documentum Life Science solutions – whether this be Webtop, DCM or FirstDoc, old-time clients are somewhat cautious as they feel they have been burned in the past by Documentum directions that were discontinued and left them on old platforms.
- Product or Consulting Solution – As a consulting solution, clients are concerned about what the total cost of the solution will be and how tightly they might be tied to only consulting from Documentum. One example included DEMA that is a migration utility that can only be used as part of a consulting arrangement with Documentum consulting.
- D2 – The life sciences solution is heavily tied to D2 and customers we have talked to are hesitant to jump to D2 based on past experience and some some concerns regarding scalability.
- Documentum Relationship – Most Documentum Life Science customers have gone through multiple sales representatives and some have been audited. Many clients are wary of the “next thing that Documentum wants to sell me” when it comes to both D2 and the migration/consulting required for the Life Sciences solution.
The Life Sciences Solution has clearly been a focused activity for Documentum and includes many portions for a full-product. Documentum clients have been wary in the past as many have been burned by previous announcements regarding DCM or FirstDoc. With the addition of Jennifer, Jessica and other experienced professionals, the product/solution has evolved and merits a fresh look from Documentum customers.