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No small change

No small change

FRAMINGHAM (02/18/2004) - Kolette Fly, who helped develop Pfizer Inc.'s electronic data capture system, knows firsthand that asking people to change the way they work can be as traumatic for some as asking them to bungee-jump off a bridge. An epidemiologist at Pfizer who heads clinical trials for the treatment of metabolic diseases, Fly remembers the first time she sat down with the nurse coordinator of a university hospital that Pfizer wanted to recruit for a new study. As soon as the coordinator saw the computer being pulled out of the box, she held up her hand and announced that computers were the "foot soldiers of the devil."

Fly and an IT person spent the next three days trying to overcome the coordinator's digital fears. They worked closely with her to explain computer basics and how Pfizer's Investigator Net (I-Net) system -- an electronic data capture system that automates data collection and analysis for drug development studies -- would make her work easier and more efficient. But the coordinator remained unconvinced, to the point where Pfizer was about to cut its losses and pull the hospital from the multicenter study. Then, in a grand "aha" moment, the coordinator realized that she could log in and navigate the system by herself without any coaching, and that the system "wasn't out to get her," says Fly. At that point, her resistance evaporated and she became a convert. The hospital became the top patient recruiter for the program, and the coordinator even volunteered to do road shows to preach the benefits of the system to other sites. "If this old dog can learn this, there's no reason anybody else can't," she told Fly.

Kolette Fly, who heads clinical trials for Pfizer, worked closely with nurses and doctors to sell them on a new electronic data capture system for Pfizer's drug trials.

Companies can develop or purchase IT systems that promise to cut costs, streamline operations, wash the car and whiten teeth, but CIOs know that if the users don't like a new system, they can kiss the promised value good-bye. That's why change management is so critical to the success of any new system. A well-thought-out strategy -- one that's driven by the needs of the business, encourages user input during the development phase, ensures proper training and keeps the lines of communication open at all times -- will go a long way toward making those multimillion-dollar technology investments contribute to the bottom line.

The four CIO Enterprise Value Award winners in this story -- Pfizer, the Chicago Police Department, The Procter & Gamble Co. and The Guardian Life Insurance Compnay of America -- have devoted plenty of blood, sweat and tears to convincing their users that change is for the better. Here's how having a solid change management strategy has paid off big time for these companies.

Winning over the rank and file

Take a grizzled, 50-year-old cop who's been patrolling the streets for decades and has grown quite comfortable filling out five-ply carbon forms to process all his arrests and casework. Then you suddenly order him to start doing his reports on a computer, an alien-looking object he may have never laid a finger on in his life. Indeed, one veteran cop on his first day of system training on a PC picked up the mouse without logging on, pointed it at the screen and started clicking away. When nothing happened, he asked why the damn thing wasn't working.

That's the whopper of a change management task that the Chicago Police Department -- the second-largest department in the country with more than 16,000 police officers and civilian employees -- faced as it began developing the Grand CIO Enterprise Value Award-winning CLEAR (Citizen Law Enforcement Analysis and Reporting) system, a relational database that sifts through massive amounts of data to give officers the information they need to fight crime.

In fact, when the case report component of the first CLEAR module, a criminal history records information system that also produces arrest reports for detectives, was rolled out in 1999, it was a disaster. The detectives hated it for a number of reasons: It wasn't user-friendly, the process of getting approval from supervisors proved arduous and involved multiple screens, and detectives weren't given proper training. After a year of listening to detectives' grumbling, managers realized they had to do something.

First, they set about building internal competence in the information services group, and that meant replacing more than half of the management team. "It was a good team, but we needed a different set of skills -- people who could manage a large-scale enterprise, people with business skills, project managers, development directors who could understand the business needs of our users and manage a team that would build out, and understand the enterprise structure we were building," says Ron Huberman, who became assistant deputy superintendent of information and strategic services for the Chicago Police Department in 2001. After revamping his team, Huberman focused on training his technology staff, from entry-level developers all the way up to senior managers. At that point, the information services group was ready to begin full-fledged development of the new system.

They began by sending a team of their best programmers out to the field for six weeks to document all the issues users had with the system. The group came back with 200 specific requests for changes, ranging from implementing an easier approval process to changing the format of how the reports printed. IS leaders also made it a point to glean user input throughout the development process. They instituted JAD (joint application design) sessions, which involved teams made up of management, users and technical staff. They formed focus groups from all ranks to gather input. Teams of officers went out to the 25 districts to field-test new apps and train officers. Having officers -- not civilians -- be the trainers has made a huge difference to the cop on the street.

"There's a certain degree of comfort (with other police officers)," says Sgt. Howard Lodding. He is one of a number of cops from the street who have been brought in to the information and strategic services division as part of the department's change management strategy. A few years ago, there were no officers in the IT shop; now there are 18, and their background in the field helps them design modules in the CLEAR system with users in mind. Their experience also ensures them respect in the field when they train users on the system.

Paul Gaffney, CIO at Staples Inc. and an Enterprise Value Awards judge, sums up the monumental task the CPD faced: "I can't imagine a more difficult change environment than an organization like a very old police department. You have longtime employees. They're used to doing things a particular way. They succeeded in not only delivering the right technology but also embracing that technology and unlocking all the value."

Selling the system

Though it might not be as dramatic as cops switching from ballpoints to bits, Procter & Gamble still had plenty of user resistance as it rolled out its Corporate Standards System (CSS). CSS is a global, centralized application that manages the company's technical standards around each product. Technical standards are a critical component of the company's product lifecycle management process -- they are the communications links that connect everything from R&D to the product supply department for the purchase, manufacture, storage and shipping of materials and products. The beauty care group, for example, has an average of 125 standards for such key information as formulas, regulatory clearances and packaging instructions, and each project identification code or SKU (overall, the company has about 55,000 SKUs in current production). CSS allows the reuse of existing tech standards and lets its more than 8,200 users share data across the globe. (Previously, people had squirreled away that info in any number of places, including three-ring binders, the occasional website and some electronic workflow tools.)

When working on the development of P&G's CSS system, John Planalp, associate director for corporate R&D, wanted input from business units that were grappling with a lot of complexity. In P&G's case, that meant studying the needs of Western Europe, which contains a number of different countries, languages, brands, country-of-sale agreements and artwork. He says that he wanted to make sure the tool could handle such a wide variety of inputs, without designing it in such a way that users in a simple business -- say, a brand of kitchen towel in a country with a single language -- would struggle with it, or worse, not use it.

The main objective of P&G's project leaders was to show employees how CSS would improve their workflow. They did Web-based training and set up a help desk that follows up on every request from employees. In describing the rollout, Planalp and other execs like to talk about a 60-day immune response from users. That's about how much time it took for employees to get over their resistance to the new system. After that, says Dan R. Blair, director of worldwide technical standards and the business sponsor of the project, they often became advocates. When people complained about the system being too slow, for instance, employees discovered it usually wasn't the technology but the work process that was the culprit. For example, someone in R&D may have been used to documenting last-minute change requests from a retailer (such as a request from Wal-Mart Stores Inc. to change the products on a pallet) on the back of envelope. At first they found that documenting changes in CSS demanded more rigor and was thus more frustrating. After fixing the work process -- by, for instance, standardizing the approvals necessary for late change requests -- they found that the system made their life easier. "Eighty percent of the time it's not about the tool, it's about the work process," says Planalp.

Executives at Guardian Life Insurance had a similar change management challenge when they rolled out a new insurance and annuity policy administration system dubbed Transcend. The system, which replaced an aging legacy system, enables real-time automated annuity policy processing and allows Guardian to connect to third-party broker dealers and build relationships with the brokers and their customer base. According to Executive Vice President and CIO Dennis Callahan, Transcend was successfully deployed with little resistance from internal users. IT executives created the usual menu of workshops and training sessions for users when the new system was launched. But the key, Callahan says, was the partnership between business and IS -- there's no battle between the CIO and any business head for control of the agenda. "People are getting the same message from the top down. That eliminates the tension and simplifies change," he says.

Learning from failure

When companies make major changes in the way they do business, they sometimes hit a few bumps before arriving at a smooth patch of road. That's certainly been the case with Big Pharma, where, beginning in the 1980s, pharmaceutical companies tried without much success to implement electronic data capture systems. But now, Pfizer is one of a handful of industry players that are up and running with highly successful EDC systems. Analysts say Pfizer's I-Net is one of the most advanced EDC systems in the industry, with a deployed base of 4,000 users at more than 2,000 investigator sites in 36 countries.

But the change management hurdles were huge. Similar to the Chicago Police Department, internal and external users at Pfizer had to move to an online environment from the tried-and-true paper-based environment they'd been working in since the dawn of drug discovery. Clinical teams were very comfortable with paper case report forms (CRFs), on which patient data, such as demographics and vital signs, was collected and analyzed.

The collection and processing of trial data represents 40 percent of the cost of new drug development and is a gargantuan chunk of money, given that the average cost of developing a new drug is more than US$800 million. One of the obstacles Robert Goodwin, worldwide head of clinical data acquisition and management, and the business champion for Pfizer's I-Net system, faced was overcoming the fears of his R&D folks that the automation and standardization of CRFs would crush their creative abilities. For example, they feared that a standardized report form would hamper their flexibility to collect information while exploring new ways to do medicine. The company got their buy-in by asking for R&D's input on the electronic report forms. Ultimately, 80 percent of these forms became standard, leaving 20 percent to be unique to each study. The new forms also led to speedier trials. "We demonstrated that with standardization, we could start studies faster instead of making each CRF a Picasso," says Goodwin.

Getting internal therapeutic teams to pilot I-Net presented another knotty hurdle. "Everyone else wanted someone else to do it. They were excited about it as long as they weren't the ones piloting it," says Fly. Project leaders worked hard to give teams that volunteered an incentive. For example, the team studying estrogen receptors involved in breast cancer became motivated by the challenge of piloting I-Net and selling its benefits to clinical trial sites as well. Once word spread that the piloting teams were finding I-Net easy to use and reliable, other teams began to climb on board.

Wowing external users

In addition to its internal research teams, Pfizer needed the cooperation of most of its investigator sites -- the more than 2,000 locations in hospitals, private doctors' offices and universities where trials are run -- for I-Net to succeed. Doctors and nurses at these sites had the same concerns as Pfizer's internal users about moving from pen and paper to electronic CRFs. Not only did many medical professionals distrust computers, but they didn't have the time to deal with user-unfriendly technology. In fact, one of the biggest sources of user frustration with I-Net in the beginning was the long log-on script. "People didn't have the patience," says Fly.

"We visited sites and listened to them. We tried to understand their business processes and how they worked so we weren't disrupting how they worked," says Goodwin. One of the seemingly simple, yet stunningly effective ways that I-Net leaders helped the computer-phobic gain confidence was by designing the CRFs (in PDF format) so that they looked like the hard-copy CRFs. And though at first they sent technical staff out to sites for training, as users became more comfortable with technology, Pfizer began training for clinical trial sites online.

The enthusiasm of internal users also rubbed off on external users. Goodwin says he and other leaders cultivated business champions -- lead clinicians, lead clinical research associates and lead data managers who wanted I-Net for their projects.

Pfizer faced different sets of challenges when implementing I-Net globally. "How do you get laptops into Estonia or India? It's easy to ship paper; when you ship electronics, there are a whole lot of different import restrictions," says Anthony Gazikas, worldwide head of development informatics at Pfizer Global Research & Development. Infrastructures in other countries are not always optimal -- users need to be convinced that the payoff from using I-Net is worth, say, the creaky 28.8Kbps connection, which may be slower than paper. To support its global users, Pfizer put in place a 24/7 multilingual help desk that supports all trials.

The cultural differences in the way doctors work around the world also need to be taken into consideration. For example, in the United States, I-Net may be programmed with plenty of edit checks -- say, if a trial participant weight is entered as 300 pounds, the app might generate a pop-up that asks, Are you sure this is correct? In Japan, however, a doctor might take offense at being questioned by a computer, Goodwin says, so Pfizer is less likely to program edit checks into a Japanese-based system.

Whether introducing new technology to doctors in Japan or cops in Chicago, the change management strategies employed by these four organizations have helped boost the acceptance rate of their systems. It may have worked for Kevin Costner when he constructed his ballpark in an Iowa cornfield, but companies know that if you build it, they don't always come. In these four cases, users have come, and, as a result, the systems have been a solid hit.

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