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eDSMB®: Your secure and compliant software solution for managing DSMBs, DMCs & Steering Committees

Compliant, cost-effective DSMB and DMC online management for sponsors, AROs and CROs.

Organize workflows, share clinical data, document decisions or recommendations,  save time and costs in a structured and compliant manner with Ethical’s eDSMB® Software and Customised Service Solution.

Why using a software for DSMBs, DMCs?

Setting up and conducting clinical trial committees requires an efficient, GxP compliant process that guarantees data security and preserves the precious time of Board MembersEthical’s eDSMB® provides a model for efficiency that prevents data breaches, saves time and costs and guarantees GxP compliance.

eDSMB® Process Summary

DSMB Process

The coordinator is guided through every step of the process.
All actors involved in the committee communicate and collaborate on-line.
Strict role-based permissions prevent accidental unblinding.


eDSMB® software for online DSMB and DMC management

Collect Board Member CVs, schedule meetings, review agenda, send invites, manage authorizations and signatures, file decisions, send notes and much more with Ethical’s eDSMB® application. Check out 8 reasons why eDSMB® simplifies the preparation and conduct of committee meetings:

YOUR NEED

Endpoint Adjudication Software Needs

To put in place a strong DSMB, DMC or Steering Committee process.

ETHICAL'S SOLUTION:


A Strong, Efficient Process

Strong, efficient process

Meetings are managed according to their open/closed/closed executive status and participants according to their role. The coordinator is guided to draft, schedule, confirm and archive meetings, creates attendees lists and assigns document authorizations. An on-line viewer allows to show documents during meetings and the on-line poll allows to record the decisions.

RESULT

Electronic Adjudication Result

Clinical data security is guaranteed, the workflow is flawless, meetings run smoothly, decisions are filed instantly. You gain confidence and efficiency in your committee management.

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YOUR NEED

Endpoint Adjudication Software Needs

To preserve the precious time of Board Members and clinical team.

ETHICAL'S SOLUTION


Simple, time-saving interface

time-saving interface

A super simple interface for Board Members with email reminders for key actions and direct links. Documents can quickly and securely be eSigned within the application. All documents, communications and decisions related to your DSMB, DMC or Steering Committee are conveniently stored all together. The coordinator has access in real time to a reporting page with graphics allowing to monitor key metrics.

RESULT

Electronic Adjudication Result

All actors involved in your DSMB, DMC or Steering Committee always know what they are expected to do, collaborate online and perform all required tasks without effort.

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YOUR NEED

Endpoint Adjudication Software Needs

To file confidential clinical data in a secure environment and share critical information with authorized individuals only.

ETHICAL'S SOLUTION


Data security and confidentiality

Data security and confidentiality

A software equipped with 1. data and document encryption, and data collection transfer & storage security, 2. secure access to the platform through two-factor authentication or integration with a Single Sign-On (SSO) and 3. strict role-based document authorization.

RESULT

Electronic Adjudication Result

eDSMB® offers the highest standard in security compliance. You prevent severe breaches such as accidental unblinding and preserve the confidentiality of key clinical data.

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YOUR NEED

Endpoint Adjudication Software Needs

An organized and easily accessible repository for all your DSMB, DMC or Steering Committee documentation.

ETHICAL'S SOLUTION


Easy access to documents

Easy access to documents

All the DSMB, DMC or Steering Committee-related documentation and communications such as charter, Board Member CVs, agendas, discussions, and decisions are collected and managed through the application. Versions and signatures are tracked and organized, with reminders sent to users and the latest available version immediately visible. An archive with PDFs of the final version of all study documents can be exported at the end of the study for the TMF.

RESULT

Electronic Adjudication Result

The eDSMB® application is the one-stop-shop for all your committee-related tasks and materials. Board Members and Clinical Team no longer waste time searching through emails and file manager or preparing documents for the TMF.

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YOUR NEED

Endpoint Adjudication Software Needs

To document all the activity and decisions of your DSMB, DMC or Steering Committee and to protect data privacy following a GxP quality and compliant process.

ETHICAL'S SOLUTION


GxP Compliance

GxP Compliance

A GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR) compliant software solution that keeps track of all actions performed in the application (document versions and signatures, discussions, decisions, etc.) and can generate activity reports.

RESULT

Electronic Adjudication Result

In case of an audit or request from senior management, your team has access in real time to the audit trail and can generate, at any time, up-to-date reports tracking the activity and documents of each meeting.

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YOUR NEED

Endpoint Adjudication Software Needs

To be able to use the same platform for all your DMCs, DSMBs and Steering Committees, leveraging costs and users experience.

ETHICAL'S SOLUTION


Scalable, cost-efficient solution

Scalable, cost-efficient solution

A multi-committee, multi-organization platform that can host as many sponsors and as many committees as needed. The investment is leveraged each time a new sponsor or committee is added to the platform.

RESULT

Electronic Adjudication Result

A multi-committee, multi-organization platform that can host as many sponsors and as many committees as needed. The investment is leveraged each time a new sponsor or committee is added to the platform.

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YOUR NEED

Endpoint Adjudication Software Needs

To prevent accidental unblinding by ensuring that documents are correctly shared with the right people.

ETHICAL'S SOLUTION


Blinded/unblinded data segregation

Blinded/unblinded data segregation

A secure software with strict role-based permissions, document authorizations and meeting templates designed according to meeting type (open / closed / closed executive).
You can use Ethical’s template or configure your meeting type by preselecting the attendees, document template and authorizations, recording and transcript options, simplifying the work of the DSMB coordinator.

RESULT

Electronic Adjudication Result

You benefit from Ethical’s experience in clinical committee management, receiving guidance for best practice, and protecting your team against the risk of sharing the wrong information. If you prefer to configure your own DSMB process, the coordinator is safely guided to achieve the expected result.

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YOUR NEED

Endpoint Adjudication Software Needs

To easily record meetings and obtain transcripts. File recordings and transcripts securely.

ETHICAL'S SOLUTION


Recordings and Transcripts

Recordings and transcripts

An optional integration with the Zoom video conferencing system. Recordings and transcripts from meetings on other systems can be uploaded in the application and be assigned access restrictions.

RESULT

Electronic Adjudication Result

The meeting recordings and transcripts are available from Zoom to authorized participants only. Writing the minutes of the meeting becomes easier.

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Request a Demo of the eDSMB® Solution

We are EU-GDPR compliant: Your Data will never be used improperly



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