Screen quick. Enroll fast

Primary concern of clinical trial execution today is enrollment. And the iModem is a strong aid in that. Equiping subjects with the iModem you will entice more subjects to participate, also if they're further from the clinic. Also, your sites can monitor these remote subjects near realtime.

Improve inclusion and exclusion

Using the iModem to monitor inclusion/exclusion parameters helps in quicker determining whether a subject will be included in the study. Of course it is possible to use the iModem data just to signal that a subject may have reached an exclusion criterium during wash out, but the continuous flow of measurements enables you to design the inclusion/exclusion criteria around trending, rather than individual measurements.

Increase subject safety

Monitoring subjects in near realtime with the iModem gives your investigators more information about the safety status of a subject. The clinical trial website also evaluates readings when they come in and immediately alerts the investigator when values or trends seem out of the expected ranges.

Increase compliance

Subjects equipped with an iModem system tend to be significantly more compliant with the protocol. Sure, they may forget an occasional reading, but you will know. And you will know directly, when it happens. Your investigators responds to such non-compliance motivating the subject again.

Feed forward compliance

The iModem is equipped with a buzzer enabling you to define in your protocol what the iModem should expect. The iModem can be configured to beep whenever the subject should take readings (or a few hours after that, to allow for variation in real life). This seems pushy, but many subjects will appreciate the reminder and feel easier about participating.

Even quicker safety response

The iModem system is a two-way system. Each iModem can be reconfigured whilst in the field at home with subjects or wherever it is.

When safety monitoring is an issue, use the iModem to set individual alert levels in the iModem of a subject to detect out-of-range measurement values. When such a reading is received by the iModem, it immediately sends it through to the website, where such alerts can be set to generate alerting e-mails or SMS's to the investigator (or subject) aiding in improving the security.

Better handle adverse events

Being a top priority in clinical trials, serious adverse events should be prevented as much as possible. The iModem system helps in prevention by alerting your investigators and your trial leader with any alarming subject measurements or trends.

For instance, a well known fact is that the days leading up to a heart attack often show heart insufficiency already resulting in fluid buildup. This can be detected by regular weight monitoring and trending.

Now, when the adverse event wasn't prevented, the iModem helps to handle reporting about it to the appropriate parties. The iModem can report whether the subjects have most likely followed protocol and whether the investigator has cared well for the subject. In some cases this may save you days of investigations.

Reporting instantly

Having the data flow into your clinical trial website enables you to generate critical report about the study on the fly. Examples of such reports include reports about the speed of enrollment, the averages of the measurements, the activity by investigators on the clinical trial website and alerts that were sent out

Of course, your trial may require some specific reporting, which NetMedical can quickly implement in your trial website prior to study start, or (in some cases) even during the course of a study.

Adaptive clinical trial design

One of the buzz words for some time now, adaptive clinical trial design has been the next envisioned step in clinical trial design. Critical for the execution of such adaptive design is that during the course of the study sufficient key performance data should be present to allow for the adaptations. This is where the iModem system brings you the input you need to steer the moving target and maximize your investments.

Quicker data submissions

Data cleaning? Of course. But with validated measurements running into the clinical trial website, and being able to annotate readings and mark individual readings for exclusion from the dataset, the data is cleaned as you go.

No need to say what that does for the speed of your data submissions...

No transcription errors. None at all

When collecting data from subjects automatically, your research database fills with measurements which you can trust.

ICT costs? Down!

Envision your investigators with nothing else than a few iModems and medical device for the subjects, and a website in which to register everything. No ICT deployment of laptops, computers or other equipment that needs software maintenance, networking and other intensive IT organisation.

More subjects. Same budget

Because the iModem is not an expensive device, you can increase the number of subjects per investigator, or for the entire study, statistically increasing the results. And even with the increased number of participants still keep within budget.

Dynamic cost management

Ever found yourself in a service concept and suddenly you're over budget? NetMedical has designed the iModem to be dynamically configurable. In the startup of a study you may require every single reading to be sent, but later in the study, the data collection frequency may be tuned down. The iModem system can do that for you. Automatically.

This way NetMedical manages the costs of the system to a minimum.

Reallocating equipment over subjects

Although you may expect it, NetMedical is not in the business of selling you as many iModems as we can. We are a service oriented company and therefore want to minimize the costs of your trial. If that means that iModems and medical equipment goes from one subject to the next, the clinical trial website and the iModem support that. This means in a typical study of 1,000 patients you would need about 650 iModem sets.

Reusing iModems across studies

As with all equipment there is a hardware costs upon purchase. NetMedical does not offer rentals today, but we do offer the deactivation, and subsequently reactivation of an iModem. With that, the iModems you purchase today may be used in another study next year. We help you maximize the ROI on the iModem investment.

Data. Dates. Location

Part of what the iModem collects is the time and location of a particular measurement. The iModem system has an end-to-end time sense. This means that the iModem updates its internal clock with the server every time it send data.

Having this in place, you can trace back any measurement to an exact UTC timestamp when it was taken. To prove this, the iModem system records the measurements not only with the timestamps of the measurement, but also 5 transmission timestamps all the way up to receipt of a measurement in the clinical trial website.

Data integrity

When the iModem receives measurements (whether via Bluetooth^TM or via a cable) it is stored in non volatile memory. Power outages or other such events will not corrupt the data. Whenever the iModem has the chance it sends the data to the server confirming every measurement along the way. Then, the server checks the data and accompanying iModem system logs and stores it in the secured data storage. From there, the data is logged with the subject, and alerts and monitoring will start.

A secure system by design

The iModem cannot be queried for data. The only way the iModem will give up its data is by connecting to the NetMedical server. The same way the NetMedical servers will send data to a particular study website and have no separate way where people may access the data. Therefore, there are no outbound interfaces to the system to secure other than the predefined links. This greatly increases the inherent safety of your data.

Printed audit trail

For research results to be accepted generally a written audit trail should be present to be able to assess the quality of the research results. By using the iModem system, you can do without writing down measurements (or printing them) as there is a digital audit trail. However, legislation usually is slower than technology, and therefore you may need the data in printed form. Because the iModem data transfers are double checked and confirmed, most of the time you can print results at your office and keep them there with patient records for reference for the paper audit trail.

Clinical grade devices

The iModem works with top quality devices from manufacturers such as Omron and A&D. The medical devices have been clinically validated and approved, making them fir for use in the research environment. The iModem also has been used and proven in clinical environments, as well as in end user environments.More concerns about paper trail?

The big issue with website is that you may loose proof of what has happened and who did it. Of course, audit trails in the clinical trial website have been designed to record anything that happens on that area, but in some cases that just doesn't do it from regulatory perspective.

Enter: the digital pen.

The iModem supports the Bluetooth^TM digital pen from Anoto^TM. With this technology the investigator just writes down their notes, subject information and other in-clinic information in the paper based CRF. The digital pen transfers the written document wirelessly via Bluetooth^TM to the iModem in the clinic, which then sends it through to the server. There, character recognition is applied, together with the form's design, giving high quality data in your database. All without the presence of a computer.

Identification

The iModem has a unique serial number, of course. In addition, the medical equipment is selected to contain a worldwide unique serial numbers as well, as a combined set uniquely identifies a subject. Even in cases where more than one subject lives in a household, the system distinguishes between subjects and correctly routes measurements to the right subject.

The requirement for written backup, or for proof of validity measurements, therefore can be done in your office as it is can be traced back to the research participant.