Electronic Data Capture (EDC) for All Data Collection through 21 CFR Part 11 Compliant Proprietary Applications Accessible through an Internet Browser with a Single Login

Standard EDC Functionalities

Secure electronic document distribution to sites enabling efficient document distribution.

Secure web file transfer allows efficient capture of electronic file data, e.g., participant device export files, picture files or PDFs of source documents.

Electronic Case Report Form (eCRF)

The eCRF is adaptable to just about any data collection purpose and can be updated with only minutes of downtime.
Using the eCRF In combination with uploaded source documents, or other modes of reviewing source documents remotely, allows efficient site monitoring by enabling optimization between remote monitoring and expensive on site monitoring visits. This long term monitoring efficiency objective meant IMD was well prepared for switching to 100% remote monitoring during the pandemic and that monitoring never became a limiting factor.

Electronic Diary

As an extension of the eCRF an eDiary can be deployed with real time data capture in situations where prompt oversight enhances the quality and quantity of acquired data. The data feeds into the eCRF for easy viewing of the data.

Treatment Allocation and Test Agent Supply Control through an Interactive Web Response System (IWRS)

Simulation for optimization of treatment allocation schemes to assure trial success.

Standard or Adaptive treatment allocation based on baseline co-variates.

Tight management of test agent supply at the investigational sites ensuring control and minimizing loss.

Special Purpose EDC Functionalities

Product Safety Application for Pre- and Post Marketing Surveillance and Safety Reporting

Electronic document reposity of all information including uploaded files associated with an event.

Process control of information accumulation towards regulatory deadlines facilitating timely reporting.

Integrated with clinical study database minimizing need for event reconciliation.

Continuous Glucose Monitoring (CGM) data collection and alert functionality

For CGM data IMD provides DexCom^® Authorized Data Transfer through its G6Vue applications. Data transfer may occur through a desktop application installed on investigative sites' or study participants' PCs, or close to real time to IMD's servers through an Android mobile device application installed on either people's own or a deplyed Android device. As an add-on to the latter an alert system advising of glucose monitoring events that require immediate attention can be provided.

Medication Dose Adjustment Algorithm Adherence

Displays colleedcted data, e.g., of glucose measurements and insulin doses on the background of the protocol dose adjustment algoritm making it simple to follow the protocol for investigational sites. A surveillance module identifies adherence problems early for fast corrective action.

Hypoglycemia Induction

Using a proprietary insulin dosing algorithm the application guides plasma glucose samlping and intravenous insulin dosing to achieve the desired plasma glucose concentration.

Other

Our software development capability allow us to adapt our platform to any serve any specific purpose includign development of new functionality.