Is Sharepoint ready for Life Sciences?

If you think that the annual DIA annual meeting is a good place to find out where our industry is heading, then one possible conclusion could be that the time for Microsoft Sharepoint has finally arrived.

There are several reasons why this would be the case:

1. Customers who have made large investments in a Documentum-based EDMS environment are fed up with high maintenance costs, poor customer service and low user satisfaction scores;
2. The same clients have witnessed a shift in the regulatory climate with a move to eCTD and SPL/PIM and a corresponding opportunity to get away from monolithic electronic publishing;
3. A growth in outsourcing and increased internal workloads have led companies to place a higher value on collaboration and information sharing, something that the existing EDMS environments have a tough time providing;
4. Small and medium-sized companies that have not yet made EDMS investments are looking for BMW performance at a VW price and know they can get it!

With that as background, it is no wonder that several software and services firms see a tremendous opportunity for MS Sharepoint to take significant market share. Two companies that exhibited at DIA stand out in this space: NextDocs and First Consulting Group (FCG).

The NextDocs Solution:

NextDocs, a Microsoft business partner based in Wayne, Pennsylvania, showed its MS Sharepoint-based software suite at DIA.

As the illustration below shows, NextDocs provides solutions in four categories:

• Document Management
• Quality Management
• Compliance Management
• Marketing Management

Details on each of these is available on their web site.

Click the image to see a larger version. Hold the control key as you click to see it in a new window.

As the following list of key features shows, NextDocs (and for that matter any other Sharepoint solution) is focusing on functional equivalence with the two current market leaders, Documentum and OpenText.

• Document life cycle management provides consistency and control over document creation and management.
• Versioning provides support major and minor versions with associated meta data.
• Flexible security provides the ability to easily manage access to documents and all associated functions.
• Templates allow easy access to common document types eliminating errors and redundant effort.
• Automated workflows provide the ability to control document life cycle from creation to archival.
• Universal digital signatures provide visible embedded signatures that protect the authenticity of documents and signatures. Word, PDF, Excel and other common file format are supported.
• Support for 21 CFR Part 11 compliance is built into the product.

Other than a lower price, NextDocs and other vendors will need to clearly convey to the client base that MS Sharepoint and their enhancements to that product will deliver a richer set of capabilities that meet current needs. The most important of these will be the provision of a rich collaboration environment tightly integrated with the document and records management functions.

While NextDocs can deliver these collaboration features by simply leveraging native SharePoint capabilities, their web site unfortunately does not provide any information about this. Hopefully they will correct this important oversight soon.

On the partnership front, NextDocs has integrated their EDMS platform with the Extedo/IABG LS eCTDmanager solution. This allows eCTDmanager to make use of document inputs from NextDocs and also push the eCTD output from eCTDmanager back into the EDMS. On the services front, NextDocs has a partnership with the Healthcare/Life Sciences group of Computer Sciences Corporation (CSC). CSC can provide planning and implementation support around the NextDocs suite.

[Note: In the interest of full disclosure, CSC is my former employer. However, I do not have any ties to that organization aside from my pension plan.]

The FCG Solution:

Jeff Klein, VP of Product Strategy of FCG told me at the DIA show that there is a large market for MS Sharepoint-based content management solutions in the SMB market and also a good opportunity with companies that wish to move away from Documentum.

As it is widely known, FCG has a large installed base of their own Documentum-based EDMS solution set in the biopharma industry. Their experience in this space is certainly unrivaled and one could conclude that FCG's extensive and in-depth knowledge of the industry and of content management would give them a tremendous advantage in delivering a solid set of solutions based on Sharepoint.

Gabor Fari, currently Life Sciences Solution Specialist at Microsoft, has certainly placed his lot with FCG and the FCG FirstPoint solution set. Gabor certainly knows both this industry and the content management space having been the Manager of Global Field Marketing at OpenText. From where I sit, any direct support from Microsoft of MS Sharepoint in Life Sciences is a welcome development. Change is certainly needed and a concerted push from many quarters will be needed to make it happen.

The FCG FirstPoint solution, then, is also modular and focused on specific operations. These include:

• FirstPoint R&D (available now)
• FirstPoint MedInfo (available now)
• FirstPoint Quality & Manufacturing (future)
• FirstPoint Trial Master File (future)
• FirstPoint Sales & Marketing (future)
• FirstPoint Contracts Management (future)

As is evident from this list, FCG is mimicking their FirstDoc Documentum-based solution set.

Pricing Issues:

While I don't have any information about pricing of either solution, it can be assumed that a Sharepoint-based solution will cost significantly less than one based on Documentum or OpenText. That, of course, is related only to software licensing and annual maintenance costs.

Pricing in this industry, however, is more of an art than science. Even if there are published price lists, you can bet that the final price will be whatever it takes to win the contract. From that standpoint, I can tell you with 95% certainty that the NextDocs and FCG products will be competitively priced.

What is less certain are the services costs. No doubt, all companies that provide services (in this case FCG and CSC), have come under tremendous pricing pressures over the past 5 years. Unless offshoring is put in the mix, each service company will take a hard hit on their profit margins. This is good news for the buyer since you can dictate what you are willing to pay. Remember though that it is in your best interest to make the software and services company successful on the financial front too. After all, if they can't survive, where will you get the talent in the future?

On a more practical note, assuming that the software solution from each of these vendors will do the job, it is important that you evaluate the level of effort needed to implement, validate and support the entire environment and the cost of staff training and continuing education. This is where the real cost differentials will show up. In other words, don't forget about Total Cost of Ownership (TOC) when making the purchase decision.

Comments

[Mike Lantzy]

There is this company called KnowledgeLake who with MSFT has solved the scalability issues and offers a proven Content Management Solution that Utilizes SharePoint as a Repository. Check it out- The company is now featured by forrestor with all the big boys

[Darryl Godfrey]

Good article, but be cautious - scalability is SharePoint's weakness. SP is still focused at the department level rather than the enterprise level. Large numbers and/or large documents will cause many headaches and will require a crew of IT staff to manage. In short, the situation is not as simple as it may first appear. Documentum is a long way from being dead for heavy-weight document management.

[glaszlo]

Raj,
Some very good questions. However, I don't think that these issues will be a problem for Microsoft. More likely, the vendors that use SharePoint as the basis for their solutions will be on the spot. I also don't think the FDA will have the time to pursue this. Again, it will be the vendors who will need to undergo audits by potential customers. As an aside, I have recently learned that several biotech companies in Europe are using the FirstPoint solution from CSC in a hosted environment. The implementations are fully validated and GMP compliant too.

[Raj]

question arises, how prepared is Microsoft to take on regulatory grilling that FDA, HIPPA and other regulatory bodies conduct to ensure compliance? or is this just a matter of how vendors mould the base product? MS sure has been good on the pricing front but what about 3rd party integration, co-existance with legacy systems etc ...

[Marc Dencker]

Great post and in my eyes (admittedly biased) right on the money.

In my work as an industry architect for Health Care and Life Sciences at Microsoft I can confirm that we see a lot of demand for 21 CFR Part 11 compliant Sharepoint solutions coming from our Life Sciences customers.
feel free to contact me at marcd at microsoft dot com for more info