MainEDC™ eClinical Solution for Medical Research
of any Complexity

Faster, clearer, more transparent clinical trials
with scalable powerful platform
trusted by 136 Pharma, Biotech and CROs

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for Big Pharmŕ:

Our portfolio includes many projects from 80+ Sponsors from all over the World. Some of our achievements: start of the clinical trial (FPI) in 2 days, trials with 70,000+ subjects, first market solution based on AI for automated medical coding and more.

for CRO:

We help CROs save resources through the implementation of an industry solution that allows you to conduct clinical trials of any complexity and receive a package of documents for registration with any regulatory authority (FDA, EMA, etc.)

for Biotech:

We know how to conduct clinical trials efficiently and economically, in a situation where teams have to deal with clinical trials for the first time or not so often. We will be part of your team and help successfully launch your projects.

 

Platform

  • Deploy studies in days: median FPI 9.2 days after start. Ready-to-use tools, templates and best DM/DS practices 
  • Save budget: up to 85% off on a platform (EDC, ERT, eCOA) and up to 75% off on clinical monitoring
  • Best price on the market:
    Fixed, Fair and Open!

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IRT / eCOA

  • All types of randomization and dose regimens (our own patent for Dynamic Randomization)
  • Automate the drug supply management – significantly mitigate the human factor risk (noted by 97% of customers)
  • Compliance is up to 99.4% using active eCOA SMS/Push reminders.

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e-Training

  • Build your first study during the training with our experienced DM   
  • Increase the knowledge and advancement of Data Management and Data Science professionals (noted by 96,6% of specialists)
  • Back up your team with resources at any step - Data Managers, Data Science, Personal Mentors 

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Premium security level,
private cloud hosting

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

Prompt and easy eCRF building,
advanced Visual Edit-checks Builder


MainEDC™ ePRO ( Electronic Patient Reported Outcome) for Capture Patient Data

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

Pay as you go. Fixed, Fair and Open price

FPI (First Patient In) in days?
Make it happen with MainEDC™!

The average project start time in clinical trial industry is 12.7 weeks. We can speed up that process as fast as 5 days.
Want to know more?

Let's talk!

We have extensive and positive experience with
audits and inspections. Always happy to help MainEDC™
users answer auditor/inspector questions related to the platform.

Let's talk!

Transfer of Competence

Transfer comprises sharing of DM 365's expertise in data management, data science or drug management through our mutual work on a particular project of yours - typically, your first one with MainEDC™. We will offer you the optimal solution for your situation.

Transparency at every step
of working on the project

Best practices, useful techniques
and knowledge sharing

Îngoing support
and analytics

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MainEDC™ platform is compliant with industry standards and international regulations

  • ICH GCP E6(R2)
  • HIPAA
  • GDPR
  • 21 CFR Part 11
  • GAMP 5
  • CDISC
  • MedDRA

More

Please email us at

contact@datamanagement365.com

Let's have a conversation about your solution.
Absolutely free. No strings attached.

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