Data Without Delay
Biomedical Systems can accommodate electronic patient reported outcome (ePRO) needs utilizing both validated and non-validated questionnaires for clinical trials or consumer healthcare projects. Our innovative technology, processes, and expertise allow Biomedical Systems to offer a variety of solutions including:
Web-based ePRO | Site ePRO | Home ePRO
A Patient Reported Outcome (PRO) is self-reported measurement in which a patient assesses the status of his or her health condition. Patient reported outcomes are increasingly being utilized throughout the drug and medical device process to demonstrate efficacy and for the comparison of treatments in health policy decision-making processes. Currently, most primary and secondary endpoints in clinical trials are PROs, making it imperative for sponsors to collect auditable data. The escalating importance of PROs is evidenced by the FDA’s issuance of Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims in December 2009.
Data Collection in Clinical Trials
Traditionally, PROs have been collected on paper; however, there is a growing trend toward electronic systems which collect more reliable data and meet the fundamental elements of data quality: attributable, legible, contemporaneous, original, and accurate. Electronic PROs have also been shown to increase patient compliance, thereby, increasing the validity of study data. Biomedical Systems’ ePRO solutions include a variety of technologies to suit any protocol need using validated or non-validated questionnaires which can be loaded onto smart phones, tablet PCs, or uploaded as web-based applications. Our team of ePRO experts has developed high-value, cost-effective technologies and processes for numerous clinical and post-marketing international studies.
Biomedical Systems’ ePRO Solutions Advantage
Digitization of PROs provides a more efficient way to acquire, analyze, and manage data for clinical trials. Electronic patient reported outcome solutions are designed to minimize overhead cost, maximize efficiency, and put clients in control by providing more flexibility in site, population, and country selections for studies. Biomedical Systems’ ePRO technologies are interoperable with Windows XP, 7, and Mobile Pro. They can be integrated with electronic data collection, interactive voice response, and clinical trial management solutions. Biomedical Systems’ ePRO Solutions experts continually assess, refine, and improve the performance of ePRO processes as technology advances making us an industry leader in the implementation of ePRO services.
Biomedical Systems’ proven approach to integrating ePRO services into clinical trials is founded on the flexibility, innovations, and expertise we offer our clients.
- Portable devices, smart phones
- Simple and complex questionnaires
- Variety of population sizes accommodated
- Devices interchangeable in cases of malfunctioning
- Mid-trial changes to questionnaires
- Rapid device replacement
- Variety of training options
- User-friendly software
- Available integration with other medical devices, proprietary tool
- Pre-programmed reminders and alarms, smart phone devices
- High resolution
- SD memory card data security
- GPRS/EDGE/GSM technology
- Integration with EDC system
- Variety of data transmission options
- BMS ePRO Gateway
- In-house designed software
- Dedicated project managers
- PRO consulting with prestigious university
- 24/7 technical support
- 10 years of experience
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Biomedical Systems' Home ePRO Diary is a Windows Mobile based device that allows patients to report and transmit...
Frequency and volume of data collection, predictability of data entry times, and mobility requirements are all crucial factors in properly matching ePRO services and technology with clinical trial protocols. Home ePRO services are ideal for complex trials with frequent and/or unpredictable data entry. Biomedical Systems provides a collection of devices including the proprietary Michelangelo ePRO diary to satisfy technology and mobility protocol requirements.
Michelangelo - ePRO Diary
Biomedical Systems' Michelangelo is a high resolution Windows Mobile device utilizing multiple communication technologies and the latest generation touch capabilities to report and transmit patients’ questionnaire responses. This device can accommodate simple and complex patient eDiary needs including real time recording via eClinical software. The Michelangelo offers a variety of questionnaire formats including images, Visual Analogue Scales, etc. and supports multiple languages. Biomedical Systems' software is compatible with most smart phones that run on Windows Mobile Professional operating systems, versions 5.0 and higher, and can be reused for multiple trials.
Benefits of Choosing Biomedical Systems for Challenge Testing in your Clinical TrialDevice
- Data security via micro SD card
- Bluetooth connectivity with peripheral medical devices, i.e. Peak Flow meters
- Provides patient discretion
- High mobility
- Programmable edit checks, control patient entry
- Increases protocol compliance
- Predefined, programmed alarms
- Acoustic, GPRS, WiFi/Ethernet/Bluetooth transmission options
- Application updates available after deployment
Biomedical Systems also offers Windows-based tablet PCs for the recording of Patient Reported Outcomes...
Study protocols which require patient reported outcomes to be recording during visits to the clinical trial site can utilize Biomedical Systems’ ePRO Solutions services and technologies to quickly and efficiently capture patients’ data. Site ePRO technology includes Windows-based tablet PCs which can be particularly useful in deploying a validated PRO questionnaire. Incorporating ePRO services at the clinical trial site level can be cost-effective as fewer devices are required, generally one per site; however, where a protocol requires integration of multiple ePRO solutions, Biomedical Systems' provides the flexibility to deploy Michelangelo ePRO diary devices with tablet PCs that feature compatible operating systems.
- Large screen
- Patient ease of use
- Variety of questionnaire formats, Images/Visual Analogue Scales
- Windows XP
- High resolution
- Complex questionnaires
- Programmable edit checks
- GPRS/WiFi/Ethernet transmission options
Biomedical Systems web-based ePRO, allows patients to report Patient Reported Outcomes through a Web...
Ideal for international clinical trials in which patients have access to PCs, Biomedical Systems’ web-based ePRO technology allow patients to report patient reported outcomes through a user-friendly web interface. Web-based ePRO solutions are particularly efficient in clinical trials involving a high number of patients where less frequent data entry is required. As a multinational tool capable of capturing reliable data, web-based ePRO technology can be financially advantageous offering savings in comparison to deploying thousands of smart phone devices. Biomedical Systems can also provide these web-based ePRO services and technology for consumer healthcare surveys as well.
This tool can also be used for consumer healthcare surveys.×
Web-based ePRO Clinical Trial BenefitsDevice
- Requires patient internet access
- Multiple devices
- Multiple browsers
- Long, complex questionnaires
- Programmable edit checks
- WiFi/Internet/Ethernet transmission options
BMS ePRO Gateway
For easy and efficient access to acquired clinical trial data, Biomedical Systems offers BMS ePRO Gateway, a reporting...
BMS ePRO Gateway
For easy and efficient access to acquired clinical trial data, Biomedical Systems offers BMS ePRO Gateway, a reporting and trial management tool providing standard and user customized reports. Data captured via any Biomedical Systems’ ePRO technology is automatically transmitted to our secure servers. Transmitted ePRO data is accessible in real time through the BMS ePRO Gateway via an ASP client/server architecture that is system/browser independent. BMS ePRO Gateway can "push" data to any electronic data capture (EDC) or data management system in any customer required format. All data sets created and exported through BMS ePRO Gateway are CDISC compliant. Biomedical Systems ePRO solutions data is accessible on any computer with an internet connection and a web-browser. BMS ePRO Gateway offers Biomedical Systems customers unparalleled power and ease of use.×
Clinical trial data which is inaccessible due to transmission failure can be costly to the pharmaceutical and medical ...
ePRO and Data Transmission in Clinical Trials
Clinical trial data which is inaccessible due to transmission failure can be costly to the pharmaceutical and medical device development process. Biomedical Systems’ ePRO solutions utilize a combination of technologies to transmit eClinical data to manage the telecommunication network of any country. Biomedical Systems is the only vendor in the ePRO industry to offer a variety of data transmission options aimed at providing our clients with flexibility in site, population, and countries selections.
In countries with a less than ideal telecommunication network, Biomedical Systems’ ePRO solutions remain operational using acoustic transmission. This sound-based technology transfers data via ordinary telephone lines. Acoustic transmission does not require any additional equipment, modems, or wires to connect. Patients simply dial a toll-free number from a landline and place the ePRO device next to the handset. A secure server at one of Biomedical Systems’ receiving centers answers the call using sounds interpreted by the ePRO device to initiate the transmission of encrypted data. Data transmission is dependent on the amount of data being sent but generally takes about two minutes.
Comprehensive telecommunication coverage in North America and Western Europe allow Biomedical Systems’ EPRO solutions clients to employ wireless technology transmission options. Classic wireless data transfer utilizes GPRS, UMTS, or WiFi technology to automatically transmit acquired clinical trial data. Requiring no patient compliance for transmission, wireless data transfer of ePRO data is optimal. Additionally, this technology is allows Biomedical Systems to synchronize deployed ePRO devices when mid-study changes are required.
The Biomedical Systems ePRO data transmission advantage is achieved by integrating acoustic, GPRS, and WiFi technologies on the same device. This complement of transmission options allows patients to transfer data from virtually anywhere. If a connection is unavailable for whatever reason, Biomedical System’s ePRO technology allows questionnaires to be completed off-line and transmitted as acoustic or wireless capabilities becomes available.×
Biomedical Systems has partnered with Isis Outcomes, a subsidiary of Isis Innovation Ltd from Oxford...
Biomedical Systems has partnered with Isis Outcomes, a subsidiary of Isis Innovation Ltd from the University of Oxford, to offer clients the full PRO service cycle. The primary endeavor of this joint venture is to aid drug development and clinical trial managers in the assessment and selection of PRO measures, validating and deploying PRO instruments in support of clients’ protocol needs and regulatory requirements. Traditionally, PROs have been completed and collected on paper, but there is growing trend toward the use of electronic systems, ePRO technologies, to collect higher quality and more reliable data.
A concept evaluation is performed with the client to identify targeted endpoints. Following this discussion, a suitable PRO is selected. When a PRO needs to be modified or a new PRO developed, these processes occur in accordance with international regulatory guidelines. Subsequently the selected, modified, or created instrument and all translations are validated. Biomedical Systems and Isis Outcomes provide assistance in the selection of the most appropriate electronic platform given protocol requirements, and the PRO migrates to with the appropriate checks to ensure equivalence. The resulting ePRO is deployed in selected countries and languages, and data is collected. Biomedical Systems and Isis Outcomes can collate, analyze, and assist in the submission of acquired ePRO data to regulatory authorities.×