SUSAR Distribution

Automate distribution of Clinical safety reports and track overall compliance

SUSAR DISTRIBUTION

The current processes for generation, tracking and dissemination of SUSARs are ad-hoc, resource intensive and rely largely upon ad-hoc tools such as e-mails and excel spreadsheets. This is highly inefficient and is prone to error resulting in business liability and risk from an inspection and audit perspective. Managing distribution of information internally and external to CROs, partners and others based on Study, products and blinded/un-blinded access for organizations with portfolio of studies and products is complex. With constant resource changes, organizations are required to track and ensure access level are correctly granted and removed for inspection and audit purposes.

Quartica’s solution can play a key role in centralizing, tracking and dissemination of SUSAR information. It will eliminate manual steps thereby reducing the chance for delays or errors. The roles based access control features tightly regulate access based on study, product and blinded/unblinded access levels. The system also allows organizations to maintain user list and access level reports for audit and inspection purposes.

Benefits

Automate generation of Dear Investigator Letters.

Capture read receipts and audit of listings downloaded.

Automate notification of DILs to investigator worldwide including external CROs and partners.

Traceable security and roles with blinded and unblided access with defined time frames.

Ready to automate your SUSAR distribution process?

Key Features

Centralized tracking and dissemination of SUSAR updates.
Personalized notifications to distribution groups based on roles based access level.
Standardization of terminology and automation of data-entry.

Cumulative listings and reports based on product access.
Audit trails for tracking, notifications, responses, and supporting data management operations.
Executive dashboard views and distribution reporting.

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  - Waiver of Class or Other Non-Individualized Relief. ALL CLAIMS AND DISPUTES WITHIN THE SCOPE OF THIS ARBITRATION AGREEMENT MUST BE ARBITRATED ON AN INDIVIDUAL BASIS AND NOT ON A CLASS OR COLLECTIVE BASIS, ONLY INDIVIDUAL RELIEF IS AVAILABLE, AND CLAIMS OF MORE THAN ONE CUSTOMER OR USER CANNOT BE ARBITRATED OR CONSOLIDATED WITH THOSE OF ANY OTHER CUSTOMER OR USER. If a decision is issued stating that applicable law precludes enforcement of any of this subsection’s limitations as to a given claim for relief, than then claim must be severed from the arbitration and brought into the State or Federal Courts located in the Commonwealth of Massachusetts. All other claims shall be arbitrated.
  - 30-Day Right to Opt Out. You have the right to opt out of the provisions of this Arbitration Agreement by sending written notice of your decision to opt out to privacy@quartica.com within 30 days after first becoming subject to this Arbitration Agreement. Your notice must include your name and address, your Quartica username (if any), the email address you used to set up your Quartica account (if you have one), and an unequivocal statement that you want to opt out of this Arbitration Agreement. If you opt out of this Arbitration Agreement, all other parts of these Terms will continue to apply to you. Opting out of this Arbitration Agreement has no effect on any other arbitration agreements that you may currently have, or may enter in the future, with us.
  - Severability. Except as provided in subsection 18.1(e), if any part or parts of this Arbitration Agreement are found under the law to be invalid or unenforceable, then such specific part or parts shall be of no force and effect and shall be severed and the remainder of the Arbitration Agreement shall continue in full force and effect.
  - Survival of Agreement. This Arbitration Agreement will survive the termination of your relationship with Quartica.
  - Modification. Notwithstanding any provision in these Terms to the contrary, we agree that if Quartica makes any future material change to this Arbitration Agreement, you may reject that change within thirty (30) days of such change becoming effective by writing Quartica to privacy@quartica.com.
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20. Entire Agreement. These terms and conditions are the entire agreement between the user and Quartica and supersede any prior understandings or agreements (written or oral).
21. Additional Assistance. If you do not understand any of the foregoing Terms of Service or if you have any questions or comments, we invite you to contact our Customer Service Department by email at support@quartica.com.
22. Copyright Notice. All Website design, graphics, text selections, arrangements, and all software are Copyright © 2019, Quartica, Inc. or its licensors. ALL RIGHTS RESERVED.

Last Changes to Terms of Service: February 15, 2019

SUSAR Distribution

SUSAR Distribution

Clinical Safety Reports

Semi Annual Clinical Reports

MARS Platform

SUSAR Distribution

DSUR Distribution

SASR Reports

MARS Platform

SUSAR DISTRIBUTION

Benefits

Ready to automate your SUSAR distribution process?

Key Features