Questions & Answers

General Questions

How many projects have been managed on your EDC & IWRS platform?

Over 350 projects (phases I-IV and bioequivalence) have been successfully accomplished on MainEDC™ - EDC & IWRS platform provided by DM 365.

What therapeutic areas are you experienced in?

We have a profound experience in more than 20 therapeutic areas including bioequivalence.
For detailed information please refer to this page.

What differs you from other solutions?

We bring EDC, IWRS & Drug Supply together in a single software solution - MainEDC™ that was created by Data Management 365 developers without third-party resource acquisition or integration.

Among advantages are:

  • GCP E6 R2, GAÌP 5, 21 CFR Part 11, GDPR, HIPAA compliance,
  • Passed validation,
  • Private cloud hosting (SaaS),
  • Full audit trail based on blockchain technology,
  • Effective analytical tools for Sponsor oversight of the clinical data and RBM.

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How much time does it take to learn how to use MainEDC™? Who can take part in the training?

Our company provides several types of system training depending on your needs. We offer comprehensive training for Investigators, a deep-dive Face to Face training for data managers, web-training and materials for self-study. For detailed information please refer to the Training page. 

What is your software license model?

Our system is SaaS (Software-as-a-Service).

Can we test the system somehow by ourselves?

We provide free access to the MainEDC™ sandbox environment. The sandbox access is valid for 30 days. Feel free to test the system under various user roles. Our experts will be happy to answer your questions and guide you during the testing period if needed. Send your request for a sandbox.

How do you provide technical support?

Technical support for the system is provided by Data Management 365 own Helpdesk service via email and phone. For emergency issues, the Helpdesk is available 24 hours 7 days per week.

What will be the cost of a bioequivalence study?

Our pricing policy is clear and transparent. The cost of hosting for a bioequivalence study normally starts from 399 USD per month. Every 6th project on MainEDC™ goes free of charge. Check the details here.

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Do we need a separate application or link for IWRS?

MainEDC™ platform is an all-in-one solution where EDC, IWRS and Drug Supply modules are seamlessly integrated.

Can we use only EDC without IWRS?

Yes, it is possible to use EDC separately, if the study does not require randomization and drug dispensing and vice versa.

How often platform updates are released?

DM 365 uses Continuous Integration and Continuous Delivery (CI/CD) software development methodology in a day-to-day workflow.

If required, we plan hotfix releases on a weekly basis.

Minor platform updates are delivered for a Client in a quick and seamless manner.

New version updates take place on the yearly base, however, regulations do not permit to migrate projects between platform versions.

Introduction of new features to Client’s environments is mutually discussed and agreed by the Client and DM 365. New features often imply validation from the Client before the feature is transferred to the production environment.

How soon can we get new features?

We are constantly working on new ideas, features, and the development plan. We also take feedback and input from our Clients. We also have a backlog grooming.

New version updates take place on the yearly base, however, regulations do not permit to migrate projects between platform versions.

Introduction of new features to Client’s environments is mutually discussed and agreed by the Client and DM 365. New features often imply validation from the Client before the feature is transferred to the production environment.

What happened to the projects on the old version?

Regulations do not permit to migrate projects between platform versions. 

What time zone is applied in MainEDC™?

We use Coordinated Universal Time (UTC) which is convenient for internationally held clinical studies.

Author’s e-signature of the Form is accompanied by a Timestamp of the signing in UTC format.

Procedures have fields for local time in the Form.

Audit Trail displays all timestamps in UTC time.

We have an international study held in Taiwan and Italy. What languages are supported by your eCRF?

Electronic Case Report Forms can be built in any language. Data collection can be done in any language. Language of the platform’s interface is English.

How labor-intensive and time-consuming is it to build an eCRF in your system?

Project building is done through the medium of eCRF Builder. The Builder has ready-to-use tools, drag-and-drop mechanism and various control elements where an element can be put into the form and configured through its attributes. The attributes comprise: identification, content, layout, auto validation, user-friendly and service attributes.

Generally, you may export a Form (or the whole project) from one Project and import it to another.
The more forms you build, the wider Forms Library you have, the easier and faster eCRF building becomes.

While building, straightaway in the browser, you can instantly check how the Form looks like for an Investigator. At this exact step, you also set masks, triggers, checks and notifications (such as randomization, drug dispense, AE registration) and check how they work and make corrections if needed.

Annotated eCRF specification is available for a download in a PDF-format.

How do we set up randomization? What types of randomization are supported by the system?

MainEDC™ supports all types of randomization (simple, blocked, stratified, with limits).

You can set the randomization parameters right in the interface of the system on your own. To set up randomization you simply upload the randomization list in .xls, .xlsx or .csv format, the system automatically completes the required references – treatment groups, stratification parameters, and blocks.

It takes just 10 min to set the randomization parameters.

Read more about it

Is it possible to extend the randomization list (in other words, add extra randomization numbers to the system)?

Yes, the system can amend the current list by adding new numbers or can rewrite the list (in case applicable for the study phase).⁠

Tell us more about drug (medication) assignment and dispense options and its set up?

The platform supports the following settings, but not limited to:

  • Pre- and post medication
  • Rescue medication, ancillary materials, etc.
  • Predefined number of kits
  • Dose calculation or fixed dose
  • Dose titration
  • Different kit types
  • Kit expiry date taken in account while dispense

Certain conditions can be set to be verified before drug assignment.
It takes just 5-10 min to set dispense parameters.
Medication list is uploaded from .xls or .xlsx file.

Is it possible to extend the medication list by adding more kits?

Yes, the system may amend the list by adding new kit numbers or can rewrite the list (in case applicable for the project phase).

What options can be covered while setting the logistics parameters?

You may set various logistics schemes:

  • Auto Supply
  • Manual Supply
  • by Site
  • by Enrollment level
MainEDC™ also lets you ‘anchor’ sites to various Depots.

We have sites in different countries, different logistics depots need to be used. Is it possible?

MainEDC™ lets you ‘anchor’ sites to various Depots.

How long does it take to start a project on your platform?

From 2 weeks to 2 months on the average for the whole process, bearing in mind that the required documents are in place (ex. Specification, Test Randomization and Medication Lists).

The timelines depend on the project complexity and time taken by a Client for documents preparation, review and UAT. In case specific requirements and integration with 3rd parties required, this is subject for a mutual discussion.

How medical coding is implemented in MainEDC™?

The medical coding function is fully built-in to MainEDC™.
Moreover, the system supports automated medical coding (MedDRA, ATC, ICD etc.).

What user roles are available in MainEDC™?

Site team roles: Principal Investigator, Sub-Investigator, Pharmacist.
You may add more roles if needed and set the exact privileges and level of access.

Sponsor gets full supervision of the project is granted. The platform lets the Sponsor have a systematic, prioritized, risk-based approach to monitoring (ICH GCP E6 (R2) requirement).
Sponsor roles: CRA/Monitor, Data Manager, Medical Coder, etc.
You may add more roles if needed and set the exact privileges and level of access.

There is a strict unblinded and blinded role separation in MainEDC™.

Site personnel and the Sponsor/CRO has completely separate environments for work which ensures safety and security www.[YOURCOMPANYNAME] for Site personnel and www.[YOURCOMPANYNAME].mainedc].com for Sponsor/CRO.

Do you provide user manuals for MainEDC™?

We surely do!

How can we export the data from your system?

You can export the real time data as many times as needed. Data export takes place in the background mode not overloading the platform performance. You will get a notification on report’s readiness.

What types of data export are implemented in MainEDC™?

Data export reports are ready for your use and do not require additional configuration.

In MainEDC™ we offer the following export formats that do not require :

  • Pre-validated plain data export,
  • Pre-validated modular data export,
  • Configured SDTM data export is also available.
Data export available in PDF-formats:
  • Certified copy export (ICH GCP E6 R2 requirement),
  • Annotated CRF.

Are there any reports in MainEDC™?

By default, MainEDC™ provides 40+ built-in reports that can be further used as an effective analytical tool for Sponsor's oversight of the clinical data and RBÌ.

What are the costs related to protocol amendment with resulting CRF change?

The platform lets you make prompt adjustments and smooth mid-study updates triggered by protocol amendments.
You build eCRF on your own. We offer you 3 releases per month for free. Additional releases may incur an extra charge.

Can Investigator indicate in eCRF which Protocol version / ICF version the Subject is currently on?

Yes, if eCRF was designed with such option in place. Choosing the version number triggers the corresponding path and opens the relevant set of eCRF forms.

How does the system manage SAE data?

Once an SAE is registered in eCRF, the system can trigger an immediate alert to the list of recipients (ex. Safety Departments from CRO/Pharmaceutical companies) that get an email notification containing a PDF copy of the completed form;

Study-specific configuration allows resending auto-updates upon eCRF data editing by Investigators.

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Data Storage and Security

Where are your data centers located?

Data Centers come through qualification and assessment so that we guarantee the safety of data, backup procedures in place and a full control towards access.

We provide a private cloud hosting (SaaS) to every Client of ours which means that Client’s instance has a completely private space through a proprietary infrastructure.

Our Data Centers are located in:

  • Hetzner Online (Falkenstein, Germany)
  • Hetzner Online (Nuremberg, Germany)
  • Selectel (Saint Petersburg, Russia)
  • Selectel (Moscow, Russia)
  • IBM Softlayer (Singapore)
  • Webzilla (Texas, USA)
We are constantly expanding the list of our Data Centers. 

How do you ensure secure data storage?

Please find more details here.

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Quality Assurance

What type of quality management system is implemented in your organization? Do you have a quality check?

DM 365 has developed own Quality Management System has been maintained in accordance with the best standards of clinical trials industry and applicable international regulations and guidelines, including GAMP 5; 21 CFR Part 11; ICH GCP E6 R2; CDISC; Good Clinical Data Management Practices.

This system comprises Quality Systems Documents, Disaster recovery plan, regular training, and personnel assessment activities, validation of computerized systems, and incident management, etc.

Stability, consistency, and security of the system is also confirmed by the results of Penetration Testing and Vulnerability Assessment, internal and external audits.

For more details please refer to Quality Assurance page.

What can you say about compliance?

We adhere to industry-related regulations and guidelines, such as ICH GCP E6 R2, GAÌP 5, 21 CFR Part 11, GDPR, HIPAA, etc.

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