Decentralized and classical clinical trials of all phases
Data collection from medical devices
Pharmacovigilance source data capture
Laboratory trials
Registries, marketing and feasibility, projects clinical, drug safety, and marketing data
Leverage your individual, flexibly configurable one-stop shop for simultaneous collection of clinical, drug safety and marketing data.
The system utilizes subject self-registration with or without the access approval step, which is not only time-saving but also allows to expand drastically the search for potentially eligible subjects, even bypassing clinical sites. Intuitive interfaces, good usability ensure users comfort and speed while entering data. MainEDC™ ePRO is fully integrated with the rest of the MainEDC™ platform but it can be used independently, too.
handle decentralized trials in a most advanced way
provide good customer care
value the feedback
comply with regulatory requirements
Apply your branding to the platform by labeling both applications at one go (mobile app and web-adapted page) with your logo and style. You can publish the app in the Apple Store and Google App Market under your company name.
Invite your customers / study subjects to the web page or mobile app published under your company brand name.
The system supports subject self-registration, electronic sign-off of informed consent, personal data processing and technical agreements. Contact your customers directly, form your target audience, and use the collected data for new markets access. MainEDC™ ePRO will process up to 60 marketing indicators automatically:
cell phone number
UID
IDFA
IP
MAC
OS
user location
etc.
MainEDC™ ePRO shares the platform with EDC, IWRS and Drug Supply components of MainEDC™, also supporting the MainEDC™ Hi Load technology for larger studies.
The platform has successfully passed benchmark testing and, what is even more valuable, its high scalability has been proven by real practical use in several clinical studies enrolling up to 70,000 subjects each.
Rebranding / white-labeling
for cell phone apps,
mobile and desktop website
All MainEDC™ Data Management / Data Science
functionality is available,
including export to all formats
Subject self-registration for clinical trials, feasibility studies, marketing programs and patient registries
Quick and easy adding subjects from investigator interface
Multi-factor authentication
(SMS / email)
Immediate access to collected data
from investigator and site team interfaces
Compliance with 21 CFR part 11,
GAMP5, HIPAA
Support for up to 100 000 subjects
within a single project
Integration with wearable devices
(fitness trackers, smart watches)
Export to CDISC SDTM,
SAS, XML, XLS, and Module
Built-in medical coding
WHODrug, MedDRA, ATC, and ICD