MainEDC™ - Electronic Data Capture / Interactive Web Response System & Drug Supply Management / ePRO
COVID-19 Pack for Remote Monitoring INCLUDED to all Tiers
Every Tier Includes
- Validation Pack (IQ, VSR)
- Audits and Inspections QA Support
- SaaS Private Cloud / Personal Virtual Server
(ńlasterization in at least 2 DCs and 3xDay data backup)
- Emergency IT Support 24x7
-
Drag&Drop Advanced Study Designer
(pre-build templates, images, links, coder etc.)
- Built-in eCRF Design Approval Tool
( + eCRF Annotated MS Word/PDF generation)
- Built-in CDISC CDASH Reference
- Trial and Visit Structure Tool
- Subject Scheduling Tool
- Hybrid Study Support
- Real-time Interactive Dashboards
- Query Management Tool
- Real-Time Edit Checks and Triggers
(+ library)
- 40 Built-in reports and Report Tool
- E-Mail Notification Builder
- Blinded / Unblinded Protocol Deviations Management
- Automated Medical Coding using AI
- Protocol / Amendments / ICF Versions Management
(LEC management / personal route for subject)
- Study Documents with Electronic Signature / News Tracking
- Central and Local Lab Support
- Source Data Tracking
- Multilanguage Study Support
- Data Management Clean and Check Tool
- User’s, Sites and Investigator Management Tool
- Import Tool
- Plain Export Tool (*Excel, CSV, PDF, Module)
- Unblinded Staff Area
- Subject Transfer Tool
- Electronic Signature Support
- Users's Permissions Advanced Tool
- Audit Trail based on BlockChain technology
-
Personal link yourcompany.mainedc.com /
yourcompany.investigator.site
- Unlimited Visits / Data Points
- Pre-configured Integration
(17 - Central Labs, CTMS, ePRO etc)
- LOINC Support
- Built-in Help Center
MainEDC™ Basic
- Try 30 Days Free Trial
- Pricing per study per month $399
- Platform: Number of sites < 5
- Platform: Number of users < 50
- Helpdesk: Basic (8x5)E-mail
- Training: F2F for DM’s (*3 Full days, 24 Hours, 4 att.) $1750
- Training: Web Training per Hour $60
- Training: Self Training FREE
- Extended 3-month support after F2F training FREE
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MainEDC™ Pro
- Try 30 Days Free Trial
- Pricing per study per month $599
- Platform: Number of sites < 25
- Platform: Number of users < 100
- Platform: MedDRA Browser
- Platform: ATC Browser
- Platform: WHODrug Browser
- Platform: Risk Based Monitoring Tool
- Platform: Source Data Tracking for Remote Monitoring
- Platform: SAS Ready Export
- IWRS: Simple, Block, Permuted Randomization
- Helpdesk: Basic (8x5) E-mail
- Training: F2F for DM’s (*3 Full days, 24 Hours, 4 att.) $1750
- Training: Web Training per Hour $65
- Training: Self Training FREE
- Personal Mentor: per Hour $60
- Extended 3-month support after F2F training FREE
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MainEDC™ Enterprise
- Try 30 Days Free Trial
- Pricing per study per month $799
- Platform: Number of sites <50
- Platform: Number of users <200
- Platform: MedDRA Browser
- Platform: ATC Browser
- Platform: WHODrug Browser
- Platform: Risk Based Monitoring Tool
- Platform: Source Data Tracking for Remote Monitoring
- Platform: SAS Ready Export
- SDTM Export
- MainEDC™ Plus for Patient Access
- Software Customization by DM 365
- IWRS: Simple, Block, Permuted Randomization
- IWRS: Adaptive Randomization
- IWRS: Advanced Adaptive Randomization / Minimization
- IWRS: Drug Supply Management
- Helpdesk: Basic (8x5) E-mail
- Training: F2F for DM’s (*3 Full days, 24 Hours, 4 att.) $1750
- Training: Web Training per Hour $60
- Training: Self Training FREE
- Personal Mentor: per Hour $60
- Extended 3-month support after F2F training FREE
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MainEDC™ Enterprise Plus
- Try 30 Days Free Trial
- Pricing per study per month $999
- Platform: Number of sites <100
- Platform: Number of users <500
- Platform: MedDRA Browser
- Platform: ATC Browser
- Platform: WHODrug Browser
- Platform: Risk Based Monitoring Tool
- Platform: Source Data Tracking for Remote Monitoring
- Platform: SAS Ready Export
- Platform: Unblinded Pharmacist Area
- Platform: DM365 API / FTP Access to Data
- Platform: Extended Study / Form Library
- Platform: Two-factor authentication
- SDTM Export
- MainEDC™ Plus for Patient Access
- Software Customization by DM 365
- IWRS: Simple, Block, Permuted Randomization
- IWRS: Adaptive Randomization
- IWRS: Advanced Adaptive Randomization / Minimization
- IWRS: Drug Supply Management
- Helpdesk: Basic (8x5) E-mail, chat, phone
- Training: F2F for DM’s (*3 Full days, 24 Hours, 4 att.) $1750
- Training: Web Training per Hour $65
- Training: Self Training FREE
- Personal Mentor: per Hour $55
- Extended 3-month support after F2F training FREE
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MainEDC™ VIP
- Try 30 Days Free Trial
- Pricing per study per month: Tailored
- Platform: Number of sites Unlimited
- Platform: Number of users Unlimited
- Platform: MedDRA Browser
- Platform: ATC Browser
- Platform: WHODrug Browser
- Platform: Risk Based Monitoring Tool
- Platform: Source Data Tracking for Remote Monitoring
- Platform: SAS Ready Export
- Platform: Unblinded Pharmacist Area
- Platform: DM365 API / FTP Access to Data
- Platform: Extended Study / Form Library
- Platform: Two-factor authentication
- SDTM Export
- MainEDC™ Plus for Patient Access
- Software Customization by DM 365
- IWRS: Simple, Block, Permuted Randomization
- IWRS: Adaptive Randomization
- IWRS: Advanced Adaptive Randomization / Minimization
- IWRS: Drug Supply Management
- Training: F2F for DM’s (*3 Full days, 24 Hours, 4 att.) $1750
- Training: Web Training per Hour $60
- Training: Self Training FREE
- Personal Mentor: per Hour $45
- Extended 3-month support after F2F training FREE
- Helpdesk: Advanced (12x5) Email, Phone Support, Personal Manager
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Basic
|
Pro
|
Enterprise
|
Enterprise Plus
|
VIP
|
|
Try 30 Days Free Trial
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Try 30 Days Free Trial
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Try 30 Days Free Trial
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Try 30 Days Free Trial
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Try 30 Days Free Trial
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Pricing per study per month
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$ 399
|
$ 599
|
$ 799
|
$ 999
|
Tailored
|
|
Platform
|
|
Number of sites
|
< 5
|
< 25
|
< 50
|
< 100
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Unlimited
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Number of users
(Investigators, CRAs, DMs, MMs, MCs etc)
|
< 10
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< 50
|
< 100
|
< 250
|
Unlimited
|
Number of Subjects
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< 100
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< 500
|
<1.000
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< 10.000
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Unlimited
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ATC / ICD Browser
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Yes
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Yes
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Yes
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Yes
|
Yes
|
SAS Ready Export
|
|
Yes
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Yes
|
Yes
|
Yes
|
Source Data Tracking for Remote Monitoring
|
|
Yes
|
Yes
|
Yes
|
Yes
|
Risk Based Monitoring Tool
|
|
Yes
|
Yes
|
Yes
|
Yes
|
MedDRA Browser
|
|
Yes
|
Yes
|
Yes
|
Yes
|
WHODrug Browser
|
|
|
Yes
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Yes
|
Yes
|
Sponsor Access Tool
|
|
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Yes
|
Yes
|
Yes
|
CDISC Wizard
|
|
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Yes
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Yes
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Yes
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Data Science Features,
Mass operations with Queries, Forms, Fileds.
|
|
|
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Yes
|
Yes
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Unblinded Pharmacist Area
|
|
|
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Yes
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Yes
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DM365 API / FTP Access to Data
|
|
|
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Yes
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Yes
|
Extended Study / Form Library
|
|
|
|
Yes
|
Yes
|
Two-factor authentication
(sms, e-mail)
|
|
|
|
Yes
|
Yes
|
SDTM Export
|
|
|
Yes
DM 365 Setup
|
Yes
DM 365 Setup
|
Yes
|
Software Customization
|
|
|
|
|
Yes
DM 365 Setup
|
Adjudication Committee Tool
|
|
|
|
|
Yes
DM 365 Setup
|
3rd Party Integration
|
|
|
|
|
Yes
DM 365 Setup
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Qualified private environment setup, one-time activity
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$ 399
|
$ 399
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$ 399
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Included
|
Included
|
|
IWRS
|
|
Simple, Block, Permuted Randomization
|
|
Yes
DM 365 Setup
|
Yes
|
Yes
|
Yes
|
Adaptive Randomization
|
|
Yes
DM 365 Setup
|
Yes
DM 365 Setup
|
Yes
|
Yes
|
Advanced Adaptive Randomization / Minimization
|
|
|
Yes
DM 365 Setup
|
Yes
|
Yes
|
Drug Supply Management
|
|
|
|
Yes
DM 365 Setup
|
Yes
|
|
Helpdesk
|
|
Basic (8x5) + Emergency(24x7)
Email
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Yes
|
Yes
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Yes
|
|
|
Extended (8x5) + Emergency(24x7)
Email, Phone Support
|
|
|
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Yes
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Yes
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Advanced (12x6)+ Emergency(24x7)
Email, Phone Support, Personal Manager
|
|
|
|
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Yes
|
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Training
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Face-to-face or web training for Data Managers
3 full days, 24 hours, up to 4 attendees
(traveling and accommodation are not included)
|
$ 1750
|
$ 1750
|
$ 1750
|
$ 1750
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$ 1750
|
Face-to-face training
up to 4 hours for Investigators
(+video-training recording and access)
|
|
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$ 900
|
$ 900
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$ 900
|
Web Training
(+video-training recording and access, per hour)
|
$ 70
|
$ 70
|
$ 70
|
$ 70
|
$ 70
|
Personal Mentor ( DM / Analyst / IWRS Specialist )
(online consulting, per hour. )
|
$ 60
|
$ 60
|
$ 60
|
$ 60
|
$ 60
|
Self Training
|
FREE
|
FREE
|
FREE
|
FREE
|
FREE
|
Extended 3 month support after 3 days training
|
FREE
|
FREE
|
FREE
|
FREE
|
FREE
|
MainEDC™ ePRO Platform
|
Basic
|
Pro
|
Pro Plus
|
Enterprise
|
Enterprise Plus
|
VIP
|
Pricing per study per month
|
$ 999
|
$ 1,499
|
$ 1,999
|
$ 2,499
|
$ 2,999
|
$ 4,999
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Number of surveys
|
< 20
|
< 50
|
Unlimited
|
Unlimited
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Unlimited
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Unlimited
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Number of subjects
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< 50
|
< 300
|
< 1,000
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< 2,500
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< 5,000
|
10,000+
|
MainEDC™ NIS (non interventional studies, up to 1,000 Subjects): minimum 3 studies — $ 299/month per study
MainEDC™ for non-profit use: minimum 4 studies — $ 99/month per study
Send request
Technology Transfer
The budget calculation is based on a clinical trial protocol/synopsis/assumptions.
Please send your protocol/synopsis/assumptions to contact@datamanagement365.com and get your budget proposal.
Go with DM 365 Technology Transfer and get the Tier down price
Send request