February 4, 2011 | Aris Global, which has been in existence for about 20 years, is best known for its software solutions for safety and pharmacovigilance. Two years ago, the company tapped Sylva Collins to expand its software solutions and services to other areas of eClinical research. Collins has a wealth of eClinical expertise—about a decade ago she introduced electronic data capture (EDC) to Novartis (see, “Master of the EDC Universe”, Bio•IT World, Aug 2004) and later had a stint at Kendle, a contract research organization.

“We’re bringing EDC in an integrated environment. I believe integration will have significant benefits for the efficiency of clinical development,” says Collins, vice president of clinical solutions at Aris Global. Integration must be done in a smart way, focusing on what’s important and valuable, rather than integrating everything just for the sake of it.

“We’re building an environment where our EDC system will be integrated with our ARISg safety system,” Collins continues. “Safety is being used by many large and medium pharmas. We have partnered with an EDC vendor [British company InferMed]. Our EDC system, agCapture, is a modified and rebranded version of InferMed’s .net-based EDC system, MACRO.

Collins maintains that the choice of EDC software is only a small part of deploying successful eClinical solutions. “Reliable and responsive support systems and effective change management and processes are critical for successful deployment,” she says. “At Bayer, Novartis and Kendle, the choice of the system wasn’t as critical as how you make it successful. At Bayer, we didn’t even have laptops or the Internet! At Novartis, the Internet wasn’t that reliable—it was the support around it, processes, training, setting expectations and managing change. At Novartis, we were so successful that the CFO announced that converting from 100% paper to 100% EDC saved the company $100 million annually.”

Support Structure

At Aris Global, Collins’ chief role is building the support—the people, the processes, the training, the help desk, the entire ecosystem. “I’ve managed over 1,000 EDC trials in three different companies,” says Collins. “You learn a lot through experience, what users are looking for and what keeps them productive. The right processes are the key. You can’t do EDC by applying paper processes. You have to ask the question—how do we reap the benefits of eClinical, rather than just pushing technology for the sake of it? We need to lock databases faster, clean data faster, and do it more cost effectively.”

When it comes to EDC adoption by the pharma industry, Collins observes that it has been very slow—certainly slower than she might have predicted a decade ago. “In the last 2-3 years, it has started to pick up, but my estimate is that at least 50% of all trials are still using paper. 50% EDC is better than what it was, just 20% a few years ago.”

Collins says with regret she doesn’t hear too many presentations at conferences where companies are announcing the benefits of EDC. “The benefits are supposed to be faster, better, cleaner data, greater efficiency,” says Collins. “In some quarters, I hear companies are not happy because EDC is expensive.” Collins says it would be an interesting exercise to analyze why some companies are evidently spending so much money on EDC, while in her experience it saved her former employers so much money.

“There’s a lot to be gained if EDC is done right,” says Collins, but deploying successful clinical systems is “a huge change-management project.” Aside from the technical challenges, the habits of personnel must change as well, necessitating the adoption of new processes and staff training.

In the safety arena, Aris Global’s chief competition comes from Oracle/Phase Forward. The system monitors adverse events, recording all safety incidents whether in clinical trials or from market reports. (All serious adverse events must be reported to regulatory authorities within days.)

Among Aris Global’s other systems is one called Register, which is used to track regulatory submissions, and another called agXchange SIR for automated report distribution including safety reports.

“If companies focus and look for smart integration, they will have success,” says Collins. “Integrated eClinical [technology] has been discussed for 20 years, and yet there isn’t a single example in the industry where a company has fully integrated the environment. It doesn’t have to be fully integrated, but it needs to add value. If you have this huge grand vision that everything has to be integrated, you’ll never get there. I urge companies to take smaller steps and integrate what really adds value.” •