Presolicitation Notice – 70– Oracle Argus Software and Support (Brand Name or Equal)

Notice Type: Presolicitation Notice

Posted Date: 22-AUG-14

Office Address: Department of the Army; U.S. Army Medical Research Acquisition Activity; US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014

Subject: 70-- Oracle Argus Software and Support (Brand Name or Equal)

Classification Code: 70 - General purpose information technology equipment

Solicitation Number: W81XWH14T0430

Contact: Matthew D. Teel, 3016192799 mailto:[email protected] [US Army Medical Research Acquisition Activity]

Setaside: N/AN/A

Place of Performance (address): US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD

Place of Performance (zipcode): 21702-5014

Place of Performance Country: US

Description: Department of the Army

U.S. Army Medical Research Acquisition Activity

U.S. Army Medical Research Acquisition Activity

PRESOLICITATION NOTICE CLASSIFICATION CODE: 70 SUBJECT: Oracle Argus Software Licenses and Support (Brand Name or Equal) SOLICITATION NUMBER: W81XWH-14-T-0430 RESPONSE DATE: August 22, 2014 contact POINT: Matthew Teel, Purchasing Agent at, [email protected]. This is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2001-27. This is an unrestricted requirement. The North American Industry Classification System (NAICS) code is 511210, and the size standard is $25M. The United States Army Medical Research Acquisition Activity (USAMRAA) has a requirement for the United Stated Medical Research Materiel Command (USAMRMC) for Oracle Argus Software to replace the existing Oracle Empirica Trace software that is set to be discontinued in 2016. Background: The Oracle Empirica Trace Serious Adverse Event (SAE) reporting software is presently used as part of a suite of Oracle products required to support FDA regulated clinical research activities for the US Army Medical and Materiel Command (USAMRMC). The Empirica Trace product, which is maintained by the Enterprise Information Technology Project Management Office (eIT PMO), will lose vendor support and reach the end of its lifecycle in April 2016. However, due to DoD regulation OPORD 2013-111, the eIT PMO is forced to make a software transition prior to July 2015, as the existing software product, Empirica Trace, will not run on the Microsoft Server 2008 R2 (64-bit) operating system, which is the Army standard operating system. See the directives noted below. Directive 1: Army Cyber Command (ARCYBER) - OPORD 2013-111 states all 2003 servers need to be decommissioned EOY 2013. MS is no longer supporting Windows 2003 operating system. Note: The eIT PMO has completed a project objectives and milestones (POAM) and has approval for an extension to run the Empirica Trace SW until July 2015 in order to install, migrate, and validate a compatible SAE solution capable of integrating with existing Oracle SW Inform GTM products already owned and in use by the Command. Directive 2: The replacement software (Oracle Argus Brand or equal to product), like the Empirica Trace software, must support the stringent security controls and compliance with U.S. Food & Drug Administration (FDA) 21 CFR Part 11 electronic records and signature requirements. The eIT PMO requires a product that provides the functional capability of the existing Empirica Trace software. Prospective offeror solutions must meet the minimum essential characteristics and requirements described below: Minimum Essential Characteristics The Oracle Argus (brand name) or equal to software must meet the following requirements: 1. Help clinical research organizations collect, code, analyze and report adverse events, as well as meet regulatory reporting deadlines and global requirements. 2. Speed information delivery, prevent delays, and provide visibility into work-in-process and due dates 3. Provide automated delivery of reports to recipients based on case characteristics, product identity, and recipient requirements resulting in timely, accurate, and flexible regulatory compliance 4. Enable users to meet deadlines through its support of general-case lists reports, blinded reports, and periodic reporting requirements for line listings of events and as well as detailed analysis of the impact of new findings on the safety profile of the product in an automated and coordinated manner 5. Provide a fundamental building block for efficiently capturing and managing adverse event report data across the full product life cycle from clinical development through post-marketing 6. Can deliver a powerful and complete platform for companies to realize the benefits of proactive pharmacovigilance and risk management when combined with advanced techniques such as data mining, data visualization, and signal detection and management products 7. The software must be able to support the full migration of all data from the Empirica Trace Oracle 11g database to the new system. 8. The software must be capable of interfacing with Oracle Inform GTM. 9. The software must support Microsoft Windows 2008 R2 (64-bit) operating system. 10. The software must be able to perform authentication using Public Key Infrastructure, (PKI), such as DoD Common Access Card (CAC) or DoD External Certificate Authority (ECA). 11. Must be compliant with Title 21 of the Code of Federal Regulations (CFR), Part 11 requirements. 12. The SAE/Empirica Trace replacement product must receive a Certificate of Networthiness (CoN) by the government. The license maintenance vendor must support the government with any technical application modifications to ensure the government can receive a CoN. More specific software requirements: Unique ID Requested Capability Description System shall be web-based to facilitate remote access from outside the Command's technical infrastructure by authorized personnel. Systemshall be primarily based on a pre-marketing investigational product safety reporting requirements. Provide the capability to migrate existing Empirica Trace data to a new SAE system. Provide the capability to create multi-tenancy to allow per client/per protocol access. Provide the capability to import data in multiple formats. Provide the capability to export data in multiple formats to include but not limited to: XML, Excel, delimited, PDF. System should be able to integrate with other clinical data systems to such as an Electronic Data Capture Clinical Data Management System (EDC-CRDMS - Oracle InformGTM). System should possess data encryption capability for secure electronic/Internet transmission of data. Provide the capability to control, access (and prevent unauthorized access) to the system and data. Provide the capability to detect and report unauthorized attempts to access the system. Provide the capability to auto log-out users in the event of prolonged idle periods. Provide the capability to require users to change passwords on a pre-defined basis. Provide the capability to recover data in the event of a system failure. Provide the capability to create an audit trail which records data entered, entry operator, date and time of entries, and actions that create, modify, or delete electronic records. Provide the capability to generate accurate and complete copies of electronic and printed data, and system information suitable for inspection, review and copying. Provide the capability to exhibit full compliance with international regulatory adverse drug event & reaction reporting requirements for expedited and periodic reporting (FDA and ICH). Provide the capability to exhibit full compliance with HIPAA, 21 CFR part 11 and 21 CFR 312. Provide the capability that allows for administration of user access. Provide the capability to manage user information (update users, add users, deactivate users). Provide the capability to track user log-ins. Provide the capability to disable all user access to a particular study. Provide the capability to allow access for multiple, concurrent, users. Provide the capability to follow the Electronic Common Technical Document (eCTD) reporting format specifications. Provide the capability to contain template data entry screens that can be used in their existing format or have fields modified for specialized use. Provide the capability to support a library function that allows for creation, storage, and reuse of custom entry screens/forms. Provide the capability to store templates to facilitate narrative preparation. (i.e. - auto narrative) Provide the capability to link a protocol to the following; Principal Investigator (PI), product and partner. Provide the capability to perform 'batch recoding' of dictionaries. Provide the capability to include a notes section. Provide the capability to skip fields that are marked as 'not required.' Provide the capability to copy fields from an existing event to a new event. Provide the capability to choose the type of event from the following items in the form of a drop-down list, radio, or other control: Drugs, Devices, Biologics, Blood Products, Vaccines, Triage, and Other (Insert blank free form text field). Provide the capability to segregate user's visibility of blinded/unblinded data. Provide the capability to run automated edit checks (data field validation) at point of entry including range checks and cross-field checks to minimize data entry mistakes. Provide the capability to generate a query. Provide the capability to create customized checks to be executed during the data reconciliation process. Provide the capability for system users to respond to internal queries and allow for standard and free-text replies. Provide the capability for users to enter new data for a case or a data point based on a response from a query. Provide the capability to generate an exception or error-log subsequent to the data reconciliation process with another electronic system. Provide the capability to auto-code (prefer fully-integrated tool) or manually code exceptions, if necessary; system should be fully compatible with multiple coding dictionaries including multiple versions of MedDRA and WHO Drug. Provide the capability to print blank CIOMS, MedWatch, or other compliant SAE forms that can be completed by hand and data entered at another time or location. Provide a workflow functionality that allows for implementation of custom business processes to assure pharmacovigilance SOPs are followed. Provide the capability to version initial and final reports. Provide the capability to maintain a status and processing history of the SAE. (I.E. Reporting to FDA). Provide the capability to allow storage of attachments that are supporting evidence to the SAEs. (MS Word Documents, PDFs and Scanned copies). Provide the capability to track and confirm the submission (date/time stamp) of all SAE documents. Provide the capability to automatically send notifications based on custom business processes to include but not limited to; non responses to queries or a reminder to system users of SAE form submission requirements and time-line. Provide the capability of a reporting tool that has the functionality to run, print, and save reports (fully integrated preferred). Provide the capability to automatically generate a report of all new and existing SAE's per month. Provide the capability to generate printable ad-hoc reports and pre-built standard management reports to include but not limited to: simple counts and frequencies; measurement/analysis of SAE processing performance, (including Command internal and site performance pertaining to accurate and timely submission of SAE data); expedited reports (such as CIOMS, MedWatch, and ICH E2B); and other custom template FDA forms for submission. Should be able to provide the capability to send safety reports via E2B submission to the FDA. (E2B meaning - Efficacy Topics' Data Elements for Transmission of Adverse Drug Reactions Reports (ICH)) Provide the capability to automatically generate narratives. Provide the capability to generate a report to include narrative data for review by a Data and Safety Monitoring Board (DSMB) and other safety and efficacy reviews. Provide the capability to produce reports that include but are not limited to reconciliation, SAE lists, site follow-up, safety reports, and case status. Vendor should be able to provide technical support to a system administrator function during standard US business hours. System must have on-line help available to users. Key Software Characteristics Case Management Administration Global AE repository Role definition Call center Right settings Complaint data User profiles Medical information Password control Affiliate support User interface support Query Performance Coding Highly Scalable Privacy settings 64 bit Unblinding, ICSR and batch Web Farm Audit trail System integration Local language TMS Local narrative/notes DS Navigation Graphic case presentation Documentum Workflow MedDRA Workflow Web Services Configurable Fax integration Case attribute specific Empirica Integration - 7.1 Standard Pre-defined automation Signal Overrides Study Dashboard- workflow reporting InForm GTM Reporting Auto report generation & distribution Ad Hoc reporting support Transmission Status Compliance dashboards Periodic reports- strong & configurable The Oracle Argus (brand name) or equal to software license maintenance must meet the following sustainment requirements: 1. Technical Assistance (online/phone support) with development engineers and customer support specialists during standard normal business hours (7 AM to 6 PM) workdays (Monday- Friday) as long as the product is being used by the Army. 2. Feature enhancements and new product releases 3. Security patches and fixes 4. Provide recommendations specific to our configuration 5. Technical Resources, alerts and proactive support tools All responsible sources may submit a quote, which shall be considered by the agency. The competitive solicitation, solicitation amendments and all questions and answers relating to this procurement shall be made available via the Internet at https://acquisition.army.mil/asfi/ or https://www.fedbizopps.gov. The solicitation is anticipated for release to the vendor community on or about, August 22, 2014, and will only be available until September 22, 2014. Specifications of the requirement are provided in solicitation: W81XWH-14-T-0430. Potential offerors are responsible for accessing the website. Interested parties must respond to the solicitation in order to be considered for award of any resultant contract. To be eligible for an award, offerors MUST be registered with the System for Award Management (SAM) at www.sam.gov, and must have completed its representations and certification found at https://orca.bpn.gov/. All questions should be addressed in writing to Matthew Teel, Purchasing Agent at, [email protected]. Only one set of questions shall be received from each offeror. Numerous emails from one offeror shall not be accepted. Telephone requests will not be honored and bidder lists will not be maintained. All interested parties shall provide their quote to Matthew Teel at [email protected] by 12:00 p.m. ET on September 22, 2014.

Link/URL: https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH14T0430/listing.html