Are traditional software companies dinosaurs? How many of the top 100 firms on this list will be thriving in 2019? Their most dangerous rivals have moved online, using the web, following the path blazed by Salesforce.com. The buzzword is software as a service (SaaS).

Adobe, to take one example, said last week it is laying off 600 employees, or an eighth of its staff. Its crash-prone programs for graphic designers are losing popularity to easy SaaS photo-editing tools like Picnik and Splashup. Intuit, too, is struggling, with flat product revenues in the recent quarter—and web-only personal finance tools like Mint on the horizon.

Regulatory Portal

And in pharma? Where millions of pieces of paper and Microsoft Word documents are the hallowed intellectual property upon which every company depends? The industry’s reliance on Documentum is an anachronism, an embarrassment in the age of Twitter and iPhones. Is anyone in this industry doing anything new? 

Dirk Karsten Beth’s customers are. President of Mission3, of Phoenix, Arizona, Beth lives and breathes the SaaS dogma. To a novel degree, his firm has fused project and document management. They’re united in Mission3’s SaaS clinical and regulatory offering. Like Salesforce.com, Mission3 charges a low monthly fee per project (which often means per compound under development). If you add five people or fifty to your team, inside your company or out, Beth doesn’t send you a big new bill. Here’s an earlier ClinPage article, from more than a year ago, with a bit more background.

Mission3: Not Your Father’s Documentum

When we checked in with him recently, Beth said that the firm’s growth had continued. “This year has been really good,” he says, as Mission3 has signed up life science customers of all sizes.

TMF Solution

Beth thinks the licensed enterprise software industry is dead. “Customers are not willing to fork out lots of money for legacy software or enterprise installs at this point,” he says. “Our model, our integrated platform, especially in these economic conditions, is really helping us.”

For electronic common technical document (eCTD) publishing, Mission3 can support both electronic submissions and paper-based publishing with tabs and flip sheets. “All of that can be done automatically from our web-based interface,” he says.

The company has launched a scientific authoring tool, already being used by 12 companies. WIth a partner, Mission3 is also about to debut a trial master file solution that would compete with what Phlexglobal offers (described in this article).

Version Control

The modern research environment, Beth notes, is heterogeneous. A variety of interdependent participants, within and outside a sponsor organization, must work together. As readers know, it can be challenging to manage attachments zapped between consultants, contract research organizations (CROs), vendors and geographically distant locations.

“We’re trying to give control back to the sponsor and let them work with the consultants and contractors and CROs and other contributors,” says Beth. Mission3 offers a central, web-based existence for each document. That ensures everyone works on the most recent version. There’s no need to worry that a top-secret Microsoft Excel spreadsheet has now been seen by a former employee or FDA official who shouldn’t be reading it.

The advent of Sarbanes-Oxley, Beth goes on to say, has put company statements under more scrutiny. The Mission3 environment can help, transcending simple alerts that a project is behind schedule. “We get much better fine-grained data. It means a lot more,” Beth says. That leaves humans doing what humans should do—i.e.,dealing with the individuals responsible.

Dance Partner Management

As Beth explains: “With more confidence, managers can more rapidly communicate to stake holders where things are. They are more free to do real project management. If something starts to slip, they can do project management. They can manage expectations.”

Ironically, in the most complex projects—without the right tools—the present working conditions can make it harder to find out where a project stands. Knowledge can be more distributed, problems more buried. Determining the cause of a delay may involve more than chatting with Jim down the hall.

With a few clicks, Mission3’s system can show the status of every project and every component of every project. “You don’t have to worry about where you are in the Gantt chart,” he says. “You know that. It shows you task vs. planned. You can filter it based on work group. If you want to see everything your regulatory work group is working on, you can filter on that.”

Managing Project Visibility

In some cases, he says, investors or venture capitalists are given full access to real-time reports in the Mission3 system to keep tabs on whether a regulatory milestone or clinical trial is on schedule.

In other cases, for CRO customers working with sponsors, visibility into a project may be more circumscribed. It’s at a customer’s discretion. Says Beth of CROs: “They hide a lot of that reporting information from customers. They let customers access documents. Our sponsor companies are using the system to do the opposite.”

Mission3 Screenshot: Company At A Glance

As buzzwords become more common, as jargon is used outside the circles of people who know exactly what it means, it is common for business terms in every industry to become meaningless. Examples might include “Web 2.0,” or, well, “SaaS.” Beth speaks more precisely. When he says “SaaS” or “on demand,” he has a rigorous definition in mind. His checklist for SaaS follows in both HTML and PDF versions. For a Powerpoint deck with more detail, readers are encouraged to .(JavaScript must be enabled to view this email address) directly.

Mission3’s Life Science Checklist For SaaS

1. Is the vendor life sciences aware? Exclusive to this industry?

2. Is the provider operating in a validated data center with available validation documents? Is the provider willing to allow customers to access the data center for validation purposes?

3. Is the solution 100 percent web-based? Is anything besides a web-browser needed to access the application?

4. Was the software originally designed to be delivered over the web? Can the end user administer the software (add users, security policies, etc.) on their own? Or has the software been forced to fit that approach?

5. Is the provider also supporting the hosting? Is a service provider just fitting a product into a hosted model? Or is the provider simply trying to sell services?

6. Was the security designed to be deployed on the Internet? Is it robust enough?

7. Does the license agreement protect the customer or is it a rewritten enterprise software agreement?

8. Is the term of the agreement truly adaptable to customer needs? It should be a buy-what-you-need model.

9. Is the customer in complete control of privileges for users? Does the license model restrict customers from adding outside contractors that may be necessary to complete a project?

10. Can accounts be managed online? Can account options, payment options and billing information be changed on the web?