- March 16, 2016Read more
Registration is now open for “Leveraging Technology for Clinical Trial Success” full-day event by ACRP Canadian Chapter! Our President and CEO, Jerry Legierski, will deliver a session on Electronic Data Capture (EDC) and electronic patient diary build and validation. The purpose of the talk is to familiarize sponsors, CROs and end users with the process of building and purposing EDC and patient diary systems for their studies and to educate them on ensuring compliance and proper documentation.
The conference will include additional sessions on successful utilization of technology in clinical trials including eTMFs, electronic consent, social media and more. Register now as space is limited! For more information and to register click here.
- February 24, 2016Read more
Recently, BBC published an article summarizing how devices such as smartphones, body sensors and smart watches are technologies that are increasingly being adopted in healthcare. As leaders in patient diary and electronic data collection technology, at HealthDiary we are ecstatic about new technologies and wearables that can be utilized for clinical data collection. Implementation of patient diaries and measuring activity, vital signs and other aspects of our daily functioning through wearable devices and then utilizing that data in a meaningful way will become the basis of patient care. To access the BBC article on the topic, click here.
- February 5, 2016Read more
We are pleased to announce that Jerry Legierski, our president and CEO, will give a talk on Electronic Data Capture (EDC) and electronic Patient Reported Outcomes (ePRO) Validation and Compliance at a Toronto Conference organized by the Canadian Chapter of the Association of Clinical Research Professionals (ACRP).
Building and Validating EDC and ePRO Systems in Clinical Trials with Compliance and Quality in Mind
This session’s learning objectives are:
- Identify the regulatory requirements pertaining to EDC and ePRO validation
- Identify the key planning factors for the development process with quality and compliance in mind
- Recognize what documentation needs to be produced and retained for an audit
For more information about the Conference and to register please visit the ACRP Canadian Chapter website.
- January 13, 2016Read more
Electronic submission of diaries initially began almost exclusively via “re purposing” devices such as palm pilots and PDAs to perform one function only – deliver the patient diary with its associated notifications and collect patient data. We refer to these devices as “dedicated devices” to illustrate their dedication to only the patient diary provision and collection function, where other functionalities of the device are disabled. With the advancement of technology, we can now choose from a variety of smartphones and tablets from different manufacturers and operating systems to be utilized for patient data collection.
A dedicated device approach today means we have chosen a specific device and an operating system platform to work with such as Android or Apple, where the study app is introduced for data collection and all other functionalities of the device are controlled externally by the electronic Patient Reported Outcomes (ePRO) provider. Functionality of the device is limited and can be modified remotely as the devices are controlled by central servers. Needless to say, this approach provides a tremendous amount of control over the device as it leaves the study centre with the patient, where notifications, diary delivery times and availability windows can be modified any time and pushed instantly to the device. This is also true for any ePRO instrument changes where questions can be modified and go live in a matter of seconds. Dedicated device ePRO approach means that every patient will get the exact same type of device and complete their diaries in the same manner as all other patients will.
While the conventional provision of ePRO is to provide patients with a handheld device dedicated to study use, an emerging alternative is the Bring You Own Device method. The adoption of the BYOD approach is driven by the widespread use of personal smartphones and tablets and the ability to leverage the use of the subject’s own internet or data plan. However, the utilization of BYOD raises a number of operative and scientific concerns that will need to be sorted out before it becomes a routinely used method.
There are two ways for patients to submit data through their own devices. One is to utilize their web browsers, a process that can provide very different experiences for the patients based on the combination of device and browser used. Functionality can vary across different browsers, and an even more significant concern is the transmission of data via an open internet connection. An alternative approach is to utilize a study specific ePRO app. With the exception of potential screen size differences across devices, the app would display the ePRO instruments in a consistent manner on all devices (Yeomans, 2014).
Native apps will allow for data entry while the device may not be connected to the internet which may be an advantage in some areas with poor connectivity (Coons, Eremenco, Lundy, & O’Donohoe, 2014). However, they pose a set of concerns with the Research Ethics Boards as the data is stored on the device itself, a feature that raises concerns over potential data loss and compromise of patient privacy in the event of device loss. Security measures have to be evaluated to ensure that the patient data is stored with a satisfactory level of security and in line with the relevant laws and regulations.
A challenge in both instances with app utilization is ensuring the wide range of devices and operating systems and internet browsers that are available are accommodated. Typically, apps are developed for the most popular operating systems such as Android and iOS, which still creates a risk for excluding some countries and populations.
In contrast with dedicated devices, the BYOD approach provides less control over the devices as app notifications and updates cannot be pushed on the patient’s personal device. In other words, the patient has control over their device, and the app has to be accommodating to the environment. If the patient shuts off the sound on their phone, they will be able to ignore audio alarms that may be automatically setup on the app. The subject may also delete the app anytime, and the methods to alert research staff of such actions is limited. These factors can be a significant threat to patient compliance in the study.
- December 3, 2015Read more
A frequent complaint within the clinical research industry and a recurring theme at conferences and meetings is the integration (or the lack thereof) of electronic data capture (EDC) systems and electronic patient reported outcomes (ePRO) commonly known as patient diaries. Sponsors and CROs frequently face the challenge of working with different vendors, one for EDC and another one for ePRO, and then going through a tedious process of integrating the data from both.
Wouldn’t it be easier if everything could be done from one platform, so that logging into one system can provide you with the data submitted by the study sites as well as data submitted by the patients directly in the form of patient diaries? Vendors that have EDC and ePRO systems integrated are rare, but luckily HealthDiary is one of them. We initially started with an ePRO platform and are aware of how the sponsors and CROs are impacted by having separate EDC and patient diary platforms, as well as the effort required to consolidate the two and making sure that the sites are updating information in both systems accordingly. We have taken this experience and developed our EDC system to fully support our ePRO system and allow us to serve our clients better through unified clinical data management software (CDMS).
HealthDiary seamlessly integrates EDC and ePRO, providing simplified real-time data access from both patients diaries (ePRO) and electronic case report forms (eCRFs) completed by the sites. This allows the study stakeholders to find all study relevant reports in one system and monitor all aspects of the study including site and patient compliance for timely followup.
Our EDC system is also fully self-sufficient and can be used independently when ePRO is not required. During our 12 years of experience, we have learned that flexibility is key in such a dynamic field as clinical research. HealthDiary is capable of supporting all aspects of data collection and patient management for any study or clinical trial.
HealthDiary has been providing Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations since 2003. To benefit from our experience, please contact us today.
Fax 416 646.1689