Frequently Asked Questions
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1: Many CROs offer technology they claim can improve my clinical trials. How is Health Decisions different?
The “efficiency” systems marketed by other CROs are rooted in outdated processes that can’t accommodate a truly adaptive clinical development program. This means they have little effect on savings. Used incorrectly, they can even affect your trial outcomes adversely.
We understand that the big picture—saving you time and money—requires a strong, flexible network of interlocking components, not just an electronic interface. Our HD360˚ technology platform empowers you with transparent, immediate access to data. It gives you the ability to make mid-course strategic decisions fast, when it counts most. No other system can move your trial forward as quickly, safely and efficiently. -
2: What do you mean by "adaptive operations?"
It’s a key component of Agile Clinical Development: continuously monitoring and refining the day-to-day aspects of how your study is run, fine-tuning each process to improve efficiency and eliminate waste. Health Decisions closely tracks the key activities that impact your budget and timelines—enrollment, query resolution, data management and site closeout. So we can quickly identify areas for improvement, alerting project teams to take necessary action.
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3: How can you be sure Agile Clinical Development will help me manage my study better?
One of the most difficult parts of managing a program is keeping track of what’s going on at your investigator sites. If you can’t measure it, you can’t manage it. Our systems provide an unprecedented level of real-time detail on recruitment, queries, subject management and allocation of resources on your sites, regardless of location. This continuous information enables constant improvement. We can spot and correct potential issues before they become big problems.
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4: Will your systems save time on my international studies, including the large, complex ones?
Definitely. In fact, the larger and more complex the study, the more significant the savings. Unlike competitive systems, ours lets you closely track and manage all of your study’s details in real time from anywhere in the world. It doesn’t matter how many sites, languages or geographies are involved. Every team member—from investigator to senior management—has the ability to strategically manage their portion of the trial. So they can help to smooth the course of any program, large or small.
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5: How does your site monitoring system differ from competing solutions?
Site monitoring usually accounts for about one-third of a clinical trial budget, most of which is spent correcting mishandled data and re-doing faulty work. That’s where our award-winning SmartMonitor system makes the difference. It constantly seeks ways to eliminate waste wherever possible, achieving dramatic efficiencies where other CROs fall short.
SmartMonitor combines automated technology with flexible processes, so your monitors can work more intelligently and think critically about opportunities to improve efficiency. The result? All your sites will perform at their best—enrolling more quickly, producing useable data faster and avoiding database bottlenecks that can jeopardize your lock date. The system also lets monitors track site activities and workloads remotely, so less time and money is spent in the field. -
6: Can we use our own CRAs?
Certainly. The important thing isn’t whose CRAs you use, but that they’re equipped with our unique HD360˚platform. Instead of simply checking boxes, CRAs in Agile studies have the power to manage key site activities strategically. That can save your trial time and money.
Since our system lets you keep a close eye on each site’s progress without leaving the office, CRAs only visit sites when there’s a real need. You have fewer travel expenses, no wasted site visits and greatly reduced error rates. All of which goes a long way toward maximizing your trial’s profitability. -
7: How does your SmartPen compare to web EDC systems, like PhaseForward, Medidata or Oracle?
Using SmartPen, sites can capture key data automatically–with less time and tedious labor than other web EDC systems. That’s critical, because your study can progress only as fast as accurate data can be collected.
Here’s how it works. When investigators fill out CRFs using the electronic pen, the information is automatically transmitted to the HD360˚platform for validation. That eliminates time-consuming and error-prone keyboard entry, making better data available sooner. SmartPen also simplifies source-data verification by automatically transmitting an exact digital copy of the CRF to your Health Decisions data management team. -
8: Can we use your Data Management and/or SmartPen Data Collection services individually?
Yes, but your study will achieve only a fraction of the value possible with the full Agile approach. What really minimizes your trial’s risk and cost is the constant communication and knowledge-sharing between clinical and data management teams. By keeping this close relationship intact, we can anticipate and avoid problems, focusing your expensive resources where they’re most effective.
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9: How much training does your system require?
Good technology should be intuitive. Site teams typically master our data collection, query management and reporting systems with less than an hour of training. And though we’re always available for one-on-one assistance, training can usually be completed online. As a sponsor, you’ll be ready to access all the information you need with just a quick introduction to our easy, web-based system.
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10: We already use System X. Why would we want to consider another?
Unless you’re 100% positive that your clinical trials are reaching their full potential, you need to consider a more adaptive system. Agile Clinical Development is based on efficiency principles that have driven enormous growth and profitability in other industries but have yet to be applied to clinical research. Learn more about how our results measure up to the rest of the industry.
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11: How do you plan the regulatory approach to adaptive studies?
It’s a common misconception that adaptive methods are subject to regulatory snags. This isn’t the case for Agile Clinical Development. We’re highly experienced in navigating the regulatory approval process for adaptive designs. We’ve even negotiated first-ever FDA approval for new adaptive techniques.
Another point to keep in mind: the operational adaptive aspects our studies, which account for most of the time and cost savings, don’t require regulatory approval because they don’t affect your trial’s actual data. -
12: Has your system been audited by the FDA?
We’ve been audited several times, most recently in Spring of 2009 on a complex, 4,000-subject study. We have never received any deficiency notices (483s), and all our systems are 21 CFR Part 11 compliant.
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13: What kind of reports will I see during a study?
Everyone involved in your program—from Investigator to CEO—will receive immediate, easy-to-understand reports with the information they need to manage their portion of the trial. In short, we get the right information to the right eyes at the right time. Each team member has the essential knowledge to act in your trial’s best interest from beginning to end.
Overall, you’ll have access to more than 300 standard reports, providing near-real-time data 24/7/365 on a wide range of performance metrics. And we can easily create additional custom reports within hours or days. Beyond the actual reports, our widgets let you track top-line information anytime, right from your desktop. -
14: What's it like to partner with Health Decisions on a development program?
You can count on a close working relationship. We have to work closely with you at every stage of your project to make sure it’s as smooth, efficient and cost-effective as possible. Our goal is to provide you with the best support and service possible, so you’re always prepared to make informed decisions about the course of your trial. That means staffing your project with our most experienced, knowledgeable team members. Being available around the clock to meet your needs. And never dropping the ball in our pursuit of your study’s best interests.
We’ve built many strong relationships with repeat sponsors, and we invite you to speak with them. Contact us for a list of references.
