Safety Governance

Optimize Safety Governance process across your product portfolio

Periodic Safety Reports – PSUR

SAFETY GOVERNANCE

Organizations internal processes to manage safety meetings for products are generally driven using ad-hoc tools such as email, spreadsheets and distributed repositories. The lack of validated product portfolio, maturity profile definition and rules defining frequency of meetings makes it difficult to manage the overall processes. The processes are generally driven individually or group based and it lacks consistency and scalability. Organizations have tried to institute standardization using a combination of templates and processes. This has helped to a certain extent but the issues with consistency and standardization still remain within organizations. The lack of standardization results in inefficient usage of resources, time and capital. It also has implications from an internal compliance and audit perspective.

Quartica’s solution can help standardize the overall safety meeting management processes by allowing organization to automate the scheduling of safety meetings based on product portfolio and maturity profile. It will provide the capability to manage frequency of meetings based on product characteristics such as product maturity, therapeutic area, data lock point and others.

Benefits

Full traceability and record of meeting schedule and actual meeting for inspection and audits

Automate tracking of meeting dates, attendees
and meeting minutes.

Automate communication and integration of key decisions to various stakeholders (Aggregate Reports, Risk Management, Signal Management, etc.)

Automate scheduling and adjustment of safety meetings based on the maturity profile of the products, IBD, data lock point and planning information.

Ready to automate your Safety Governance process?

Key Features

Automated scheduling, distribution and tracking of meetings.
Scheduling for different types of safety meetings based on organizational processes.
Tracking of meeting receipt acknowledgement and attendance.

Roles based access control to support project roles and teams.
Tracking of dates and activities, enabling collection of metrics and top-down visibility.
Searching, retrieval, navigation, and reporting capability.

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  - Authority of Arbitrator. The arbitrator shall have exclusive authority to (a) determine the scope and enforceability of this Arbitration Agreement and (b) resolve any dispute related to the interpretation, applicability, enforceability or formation of this Arbitration Agreement including, but not limited to any claim that all or any part of this Arbitration Agreement is void or voidable. The arbitration will decide the rights and liabilities, if any, of you and Quartica. The arbitration proceeding will not be consolidated with any other matters or joined with any other cases or parties. The arbitrator shall have the authority to grant motions dispositive of all or part of any claim. The arbitrator shall have the authority to award monetary damages and to grant any non-monetary remedy or relief available to an individual under applicable law, the arbitral forum’s rules, and these Terms (including the Arbitration Agreement). The arbitrator shall issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrator has the same authority to award relief on an individual basis that a judge in a court of law would have. The award of the arbitrator is final and binding upon you and us.
  - Waiver of Jury Trial. YOU AND COMPANY HEREBY WAIVE ANY CONSTITUTIONAL AND STATUTORY RIGHTS TO SUE IN COURT AND HAVE A TRIAL IN FRONT OF A JUDGE OR A JURY. You and Quartica are instead electing that all claims and disputes shall be resolved by arbitration under this Arbitration Agreement, except as specified in Section 18.1(a) above. An arbitrator can award on an individual basis the same damages and relief as a court and must follow these Terms as a court would. However, there is no judge or jury in arbitration, and court review of an arbitration award is subject to very limited review.
  - 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.
19. General. Any claim relating to, and the use of, this Website, the Services and the materials contained herein is governed by the laws of the Commonwealth of Massachusetts. You consent to the exclusive jurisdiction of the state and federal courts located in Suffolk County, Massachusetts. A printed version of these Terms of Service will be admissible in judicial and administrative proceedings based upon or relating to these Terms of Service to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. We do not guarantee continuous, uninterrupted or secure access to our Website or the Services, and operation of the Website may be interfered with by numerous factors outside of our control. If any provision of these Terms of Service is held to be invalid or unenforceable, such provision shall be struck and the remaining provisions shall be enforced. You agree that these Terms of Service and all incorporated agreements may be automatically assigned by Quartica in our sole discretion. Headings are for reference purposes only and in no way define, limit, construe or describe the scope or extent of such section. Our failure to act with respect to a breach by you or others does not waive our right to act with respect to subsequent or similar breaches. These Terms of Service set forth the entire understanding and agreement between us with respect to the subject matter hereof. All sections which by their context ought to survive this agreement shall survive any termination or expiration of this Agreement.
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

Safety Governance

Periodic Safety Reports – PSUR

Risk Management

Signal Management

Safety Governance

PV Intelligence

Quality & Compliance

MARS Platform

Periodic Safety Reports – PSUR

Risk Management

Signal Management

Safety Governance

PV Intelligence

Quality & Compliance

SAFETY GOVERNANCE

Benefits

Ready to automate your Safety Governance process?

Key Features