Real-Time Reports

Patient reporting at the click of a button

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Report Module Overview


Whether you need an electronic data capture (EDC) for your system of record, or if you are using a 3rd party EDC system for capturing clinical study data, then you need the Report module as part of your solution. Clinical6 EDC can be used as a stand-alone EDC or integrated with 3rd party EDC systems and databases with EDC Link.

Patient reporting at the click of a button


If an electronic data capture (EDC) system is all you need, then our Report module does just that. The Clinical6 Report module is a simple EDC system that can be used alone or integrated with 3rd party systems.

Clinical6 EDC


The Clinical6 EDC is a system of record that allows the seamless capture of clinical study data, including capture of case report forms, patient reported outcomes, surveys, labs, and other study data throughout the duration of the trial in a secure manner. A few of the core features of Clinical6 EDC include eCRF and ePRO design, edit checks and review, and medical terminology coding.



eCRF & ePRO Design


Electronic Case Report Forms (eCRFs) & Patient Reported Outcomes (ePROs) are designed using the Clinical6 platform to collect clinical study data from investigators and patients through mobile applications and website study portals that report data seamlessly into the Clinical6 EDC.

EDC Link


EDC Link is an import/export validation approval process that allows the Clinical6 platform to easily link into other EDC’s, lab systems, connected device systems, and payment systems to continuously move the workflow and trigger these different systems when things come into the EDC for the sake of the trial.


Edit Checks and Review


Clinical6 EDC is capable of enabling edit checks on the front end, user interface for ePROs or on the eCRFs, to help reduce data entry errors or discrepant data. Automatically triggered queries can be answered and resolved in real-time or manual queries may be entered by the Data Management team using the Review workflow.



Medical Terminology Coding


Code adverse events and concomitant medications automatically with 3rd party coding system integration, or manually in Clinical6 using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary for adverse event reporting and identifying drug names in pharmacovigilance adverse drug reaction (ADR) reporting.

Global Reporting


No matter what language, country or size of the trial the report module can handle all of the requirements for multi-language, site and countries. Configured country by country to comply with individual regulations while giving a global view through patient reporting and the EDC.


Features


mHealth, IOT & Medical Device Integration

Clinical6 EDC collects patient data from connected mobile health devices (glucometers, weight scales, pulse ox, blood pressure, ECG’s, spirometers, inhalers, activity trackers, etc.) to enable seamless and effortless recording of patient study data.

Soft & Hard Data Locks

Clinical6 uses soft locks and hard locks for patient, cohort and country level data locking with sophisticated query and review workflow built in for all of the clinical operations stakeholders with configurable user access management.

Data Import/Export

When Clinical6 EDC is used as the system of record for the clinical trial data, Clinical6 EDC can easily link into CTMS, EHR, LIM systems and other databases with workflow triggers when new data comes into Clinical6 EDC, as well as export data in various formats for clinical data analysis or archival.

EDC Link

When Clinical6 EDC is not used as the system of record for the clinical study data, EDC Link is an integration link that allows the Clinical6 platform to easily connect into 3rd party EDCs serving as the system of record for automatic data exchange.

Data Protection & Privacy

Compliance 21 CFR Part 11 / EU Annex 11 Compliant
Secure HIPAA Cloud
Authentication & Encryption for PHI/PHR
Open API Architecture for EMR/EHR, EDC & CTMS Integration

Data Protection & Privacy

Compliance 21 CFR Part 11 / EU Annex 11 Compliant
Secure HIPAA Cloud
Authentication & Encryption for PHI/PHR
Open API Architecture for EMR/EHR, EDC & CTMS Integration