Legacy Support and System Integration of Health Canada’s Pharmacovigilance Safety System (Canada Vigilance)

Advance Contract Award Notice (ACAN)

Title: Legacy Support and System Integration of Health Canada’s Pharmacovigilance Safety System (Canada Vigilance)

Solicitation Number: 1000227429

1. The Purpose and Explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor.

2. Rights of Suppliers

Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes.

3. Proposed Contractor

ArisGlobal LLC

Ponce De Leon Blvd

Coral Gables, Florida 33134

4. Definition of Requirements or Expected Results

Health Canada’s Health Products and Food Branch (HPFB) reviews, regulates and approves the use of thousands of health products and foods vital to the health and well-being of Canadians. As an information based regulator, HPFB play a stewardship role that seeks to combine the best evidence with the most effective tools to protect and promote the health of all Canadians through access to safe, high quality health and food products and clear health information that is trusted in Canada and internationally.

HPFB manages health product risk using evidence-based data from programs such as the Canada Vigilance System in the post market surveillance regulatory decision-making process. HPFB collects reports of adverse reactions into the Canada Vigilance System to ensure that all Canadians can make informed decisions.

Canada Vigilance derives from a legacy system referred to as ARIS Global’s ARISg - a bilingual suite of pharmacovigilance products used to receive and process adverse reaction reports. The technologies within the ARISg suite include ArisG, AgTracker, AgExchange Electronic Submissions, and Business Objects, all of which are end of life. As such, HPFB’s Canada Vigilance System will require ongoing software support, maintenance, and licensing to remain operational and stable during modifications as we prepare to transfer to new technology.

5. Minimum Requirements

CRITERIA FOR ASSESEMENT OF THE STATEMENT OF CAPABILITIES

Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements for Health Canada:

1. The supplier must be able to acquire the following licenses for a two (2) year term with phone support to be provided 7 days a week 24 hours a day:

• ArisG for 225 users
• AgTracker for 50 users
• AgExchange Electronic Submissions for 225 users
• Business Objects for 55 users

1. The supplier must be able to align a support solution with the current on-premise technology and maintain compatibility with the Canada Vigilance technology standards described below:
   • IE 11 Browser
   • Chrome Browser
   • Sun Java JDK 1.8.0.131
   • Websphere 8.5.5.14
   • LDAP Microsoft Active Directory Server 2012
   • Oracle – Client 12.1.0.2.0 or 12.2.0.1
   • Business Objects 4.2 SP04
   • SUSE Linux Enterprise Server 12
   • Microsoft Exchange Server 2010/2013/Office 365 Pro Plus
   • Elastic Search
2. The supplier must be able to maintain the functionality of all customizations to ArisG and AgTracker and provide incident management support to quickly resolve any deficiencies.
3. The supplier must be able to determine and illustrate all business processes of interconnected system to support the legacy system and its integration into the existing Canada Vigilance system
4. The supplier must be able to determine and illustrate data mapping to support the legacy system and its integration into the existing Canada Vigilance system
5. The supplier must be able to determine and illustrate configuration mapping support for legacy system and its integration into the existing Canada Vigilance system

Justification for pre-identified supplier:

Aris Global’s proprietary software is optimized to support pharmacovigilance activities and customizations to the software have been implemented to support Health Canada’s specific regulatory responsibilities. Aris Global has in-depth knowledge of these customizations from development through to implementation.

6. Reason for Non-Competitive Award

Section 6)d. of the Government Contract Regulations is being invoked in this procurement as only one person or firm is capable of performing the contract.

7. Applicable trade Agreements and Justification for Limited Tendering

This procurement is subject to the following:

Chapter 5 article 513 (b) (iii) of the CFTA is applicable on the basis of limited tendering where the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist due to an absence of competition for technical reasons.

Article 15.10 (2) (b) of the CPTPP is applicable on the basis of limited tendering under the circumstance that the good or service can be supplied only by a particular supplier and no reasonable alternative or substitute good or service exists due to the absence of competition for technical reasons.

Article XIII (b) of the WTO-AGP is applicable on the basis of limited tendering following circumstances where the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist due to an absence of competition for technical reasons.

8. Ownership of Intellectual Property

Ownership of any Foreground Intellectual Property arising out of the proposed contract will vest in the Contractor.

9. Period of the Proposed Contract

The contract period shall be from date of contract award until 31, December 2023.

10. Estimated Value of the Proposed Contract

The total estimated value of the proposed contract should not exceed $ 3,750,000 including travel and living expenses (if applicable), and all applicable taxes.

11. Closing Date and Time

The Closing Date and Time for accepting Statements of Capabilities is 20 December 2021, 2 p.m. EST.

12. Contact Person

All enquiries must be addressed by e-mail to:

Beverly Shawana

beverly.shawana@hc-sc.gc.ca