In addition, the method of valuing a submissions management system is often different from that of valuing an eTMF system.
For instance, a mid-sized contract research organization (CRO) recently estimated the cost savings — due to case-report-form
sharing, site-closeout efficiencies, and general site-level administration — from implementing a compliant eTMF system could
approach $900,000 per year, while several top-tier pharmaceutical companies spend well over $3 million per year in submissions
support alone. The submissions support expense justification is often a time-to-market argument, in which each day a product
is delayed is estimated to cost upwards of $1 million to $100 million. (This figure is based on a daily revenue estimate
achieved by dividing yearly revenue from a moderately successful to blockbuster product — approximately $360 million to $4
billon dollars annually — by 365 days, assuming that one extra day of revenue falls almost directly to the bottom line when
a drug is covered by patent, and that all other factors are held equal; the author does not necessarily subscribe to this
method of value estimation.) The improvements in time-to-market, driven by a submissions system, are often attributed to electronically
facilitated work flows, pre-defined and streamlined approval processes, electronic signatures, and highly automated submissions
These distinctly different purposes have distinctly different values. How, then, does a company separate, prioritize, manage,
and achieve the value for an enterprise EDM project (especially when the cost of margin functionality increases rapidly beyond
rudimentary systems)? Can value even be achieved? The answer to both questions is "Yes."
CATEGORIZING EDM PROJECTS
A solid conceptual starting point involves categorizing document management solutions into four maturity states based on functionality:
(1) open information-sharing intranets; (2) controlled electronic filing cabinets; (3) compliant EDM solutions; and (4) highly
automated content publishing solutions. It is this categorization that forms the foundation for the desired end state of a
solution — and begins the road map for any EDM implementation and validation.
Maturity State 1: Open Information-Sharing Intranets
Information-sharing intranets are portal-style applications for sharing documentation. The sites are often open to general
access and may house documents relative to one specific topic or multiple topics. These solutions can be elaborate and homegrown,
using tools such as BEA Systems' WebLogic Portal, IBM's WebSphere Portal, or Oracle Corporation's Oracle Portal. Alternatively,
they may be as simple as EMC Corporation's eRoom or Microsoft Sharepoint Team Services. Functionality is normally fairly static
in these environments. However, common capabilities include: uploading and downloading of documents; creating new sites or
folders for new topics; adding, removing, and re-arranging gadgets; and manually controlling document versions.
These intranets typically do not facilitate the production or approval of documents. Controlling versions on these types of
sites often proves challenging. Movement of documents among folders and different sites can prove difficult too because loaded
content remains in the same location. Finally, the proliferation of the created sites is often uncontrollable and results
in an environment that is hard-to-search. This type of environment is almost certainly not meant to be validated or provide
enterprise business efficiency (although it can add some project document sharing efficiency).
Maturity State 2: Controlled Electronic Filing Cabinets
Controlled electronic filing cabinets provide deeper document management functionality and typically focus solely on controlling
documents being placed into well-structured files. Controlled solutions normally contain relatively well-structured proprietary,
confidential, or regulated documentation. Examples of business functions that may use controlled electronic filing cabinets
are: (1) intellectual property and litigation teams; (2) sales, franchise, and real estate administration groups; (3) regulatory
affairs teams; and (4) pharmaceutical clinical operations groups.
Collaboration capability, partially automated versioning, document-level access control, rapid document retrieval, and reporting
capabilities are the primary benefits of the controlled electronic filing cabinet. These filing cabinet solutions usually
do not provide the capability to create documents in a controlled manner; instead, they provide a controlled environment for
sharing and retrieval.