Solutions & Services

MainEDC EDC & IWRS System

Integrated, configurable, and reliable solution for impressive data capture results

Features spotlight

Private cloud hosting (SaaS)

GCP E6 R2, GAP 5, 21 CFR Part 11,
GDPR, HIPAA compliant

Blockchain technology in the audit trail

  Prompt and easy eCRF building

Quick deployment and adjustments to protocol amendments

Easy access for investigators via www.yourcompany.investigator.site

Electronic Data Capture

Reliable:

MainEDC was created by Data Management 365 developers without any third-party acquisitions or integrations.

The system is compliant with the FDA requirements (21 CFR Part 11) as well as with GCP, GAMP 5, HIPAA, and GDPR.

The system is validated and all of our clients are provided with private cloud hosting - no multi-tenant use. The data is stored in qualified data centers and we provide a full audit trail for which the blockchain technology is applied.

Functional:

  • eCRF builder
  • Laboratory data handling
  • Automated medical coding and SEC functionality
  • Ability to track SDV (incl. partial SDV)
  • All types of randomization and dose regimens
  • Drug supply, inventory management, kit replacement, emergency codebreak
  • Effective analytical tools for Sponsor oversight of the clinical data and RBM

Convenient:

MainEDC ensures quick start-up and close-out thereby saving your precious time during the study and you can make sure that if there are any mid-study updates or amendments made to a protocol that these changes will be promptly adjusted.

You can access the system from any device at any time and get the full picture of what is going on thanks to a series of comprehensive dashboards and notifications.

IWRS

  • Fully integrated with EDC
  • Can work as an independent application
  • Strictly controlled randomization and drug dispensing conditions
  • Randomize and arrange drug dispensing just from the same interface, no external links required
  • Strict role separation blinded Investigator and partially unblinded/fully unblinded Pharmacist

Benefit from MainEDC IWRS:

  • Make use of flexible, easily customizable, and fully controlled mechanism of randomization and drug dispensing
  • Enjoy all types of randomization and dose regimens
  • Automate the drug supply management mitigate the human factor risk significantly

Take Full Advantage of MainEDC

  • Save time and resources on every step that you take in the system: eCRF building, data entry, data export
  • Feel confident about your data security
  • Save time on adjustments enjoy easy and quick implementation of protocol amendments
  • Get full control of your clinical study in real time enjoy special built-in reports and analytical tools to make decisions quickly
  • Enjoy the fixed price for the private cloud, backup, and helpdesk support

Request free trial

Training

Get your team trained for MainEDC!

Types of training:

  • Deep-dive onsite training for Data Managers, 3 full days, 8 hours per day
  • Comprehensive face-to-face training for Investigators, up to 4 hours

  • Web training it can be either an extended training or a one-time consultation, we are always ready to support you with the system knowledge and share some useful tips

  • Self-training we provide educational materials to support your self-tuition

Undergo a deep-dive training on the system and enjoy extended 3-month support.

Get the best price for your clinical trial

Choose a plan

Answer a few questions
and we will pick up a tariff plan for your study

Answer the questions

Starting from $399

Get your MainEDC with private cloud, backup, and helpdesk support starting from just $399 per month

heck the pricing

Have you got any questions?
Please email us at

contact@datamanagement365.com