The GoResearch™ Patient is a mobile extension to the GoResearch™ EDC platform which enables patients to perform Peak Flow measurements (PEF) with the use of a SMART ONE ™ Peak Flowmeter device linked via Bluetooth Low Energy (BLE).
During the test, measurements are automatically transferred from the device to the App and then compared to the calculated target value based on the patient characteristic (age, height, weight, gender, ethnicity). All measurements are automatically stored for future reviews and securely transferred to corresponding patient’s clinical study documentation (eCRF file).
Although designed to work in the clinical research environment, the application can also be used in a standalone mode, which allows private use without need of any data transfer to the outside world. No cloud - no risk of unintended personal information leak.
It is not mandatory for the private use, but in order to calculate the target PEF value and make measurements comparisons possible, following parameters should be provided: age, height, weight, gender, ethnicity.
This applications works with PEAK FLOWMETER SMART ONE ™ only.
About GoResearch™
GoResearch™ is a fully validated, innovative internet platform for electronic data capture (EDC) created by 2KMM for research projects such as clinical/observational studies and patients registries. It offers a wide range of features supporting such projects in various areas such as:
• data collection with the use of individually customized case report forms (eCRF) to meet the requirements of each study,
• configuration of the information flow and the Adverse Events management procedures (including automatic e-mail notifications to safety departments),
• random allocation to a treatment arm through the built-in randomization module,
• real-time validation of the registered data (Edit Checks),
• full tracking of data modifications (Audit Trail),
• management of queries with an option of automatic query generation,
• Source Data Verification (SDV),
• ePRO, eSource and mHealth data integration through dedicated mobile and/or web applications or flexible application programming interface (API).
GoResearch™ meets all industry standards applicable to such systems, including regulatory requirements of FDA’s 21 CFR Part 11 and specific areas of GCP regarding electronic data.
During the test, measurements are automatically transferred from the device to the App and then compared to the calculated target value based on the patient characteristic (age, height, weight, gender, ethnicity). All measurements are automatically stored for future reviews and securely transferred to corresponding patient’s clinical study documentation (eCRF file).
Although designed to work in the clinical research environment, the application can also be used in a standalone mode, which allows private use without need of any data transfer to the outside world. No cloud - no risk of unintended personal information leak.
It is not mandatory for the private use, but in order to calculate the target PEF value and make measurements comparisons possible, following parameters should be provided: age, height, weight, gender, ethnicity.
This applications works with PEAK FLOWMETER SMART ONE ™ only.
About GoResearch™
GoResearch™ is a fully validated, innovative internet platform for electronic data capture (EDC) created by 2KMM for research projects such as clinical/observational studies and patients registries. It offers a wide range of features supporting such projects in various areas such as:
• data collection with the use of individually customized case report forms (eCRF) to meet the requirements of each study,
• configuration of the information flow and the Adverse Events management procedures (including automatic e-mail notifications to safety departments),
• random allocation to a treatment arm through the built-in randomization module,
• real-time validation of the registered data (Edit Checks),
• full tracking of data modifications (Audit Trail),
• management of queries with an option of automatic query generation,
• Source Data Verification (SDV),
• ePRO, eSource and mHealth data integration through dedicated mobile and/or web applications or flexible application programming interface (API).
GoResearch™ meets all industry standards applicable to such systems, including regulatory requirements of FDA’s 21 CFR Part 11 and specific areas of GCP regarding electronic data.
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