Pharmacovigilance Software

THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response. This Sources Sought is being issued by the Food and Drug Administration (FDA) for the implementation of a Commercial-Over-the-Shelf (COTs) pharmacovigilance software tool that will assist the Center for Foods Safety and Applied Nutrition (CFSAN) collect and monitor adverse events associated with foods, cosmetics, and dietary supplements. The COTS product must be capable of providing the following features and functionalities listed in the table below. 1 The system shall store and allow the FDA to accept, modify, process, review, and export case data elements relating to adverse events and product complaints, such as those included in FDA Forms 3500, 3500A, 3500B, and the Safety Reporting Portal forms for dietary supplements. 2 The system shall store case related files from web submitted reports and other FDA and Industry AE IT systems (scans of paper reports, medical records, attachments to electronic submissions, reporter correspondence, etc.) 3 The system shall provide the ability to add "tags" to products within its dictionary to maintain product characteristic and categorization data specific to CFSAN regulated products and public health activities. 4 The system shall allow the user to store case data from multiple reports, various sources and follow-up report submissions. The system shall allow for the convenient review of case data at the source report level and a case level aggregation of all source reports. 5 The system shall house a dictionary of CFSAN regulated product identifiers and characteristics, such as product and brand names, ingredients, label warnings, images, instructions for use, firm contact information, etc. for report data standardization. 6 The system shall house a dictionary of MedDRA symptom terms and custom synonyms for report data standardization. 7 The system shall store dates in case records for evaluating regulatory compliance, records management performance metrics, case review milestones, and correspondence tracking. 8 The system shall store business operation data in case records such as the format of reports received, the regulatory type of reports, and whether the event described meets the regulatory definition of "serious". 9 The system shall store information about the individuals supplying AER data, including contact information, their role such as consumer or mandated reporter, the organization they may be reporting on behalf of, etc. 10 The system shall allow the user to generate a time stamped pdf file case summary for sharing within the FDA. 11 The system shall allow the user to generate redacted PDF files of case information for distribution to the public. 12 The system shall allow the user to configure notifications to safety reviewers and non-user emails based on predefined criteria. 13 The system shall provide correspondence management functionality, paper and electronic based (correspondence history, letter generator for submission acknowledgement, etc.) 14 The system shall create new case records from CDER MedWatch E2B xml report data. 15 The system shall create new case records from ORA FACTS Oracle database report data. 16 The system shall create new case records from Reporting Platform submissions. 17 The system shall create new case records from industry XML AER submissions. 18 The system shall create new case records from Safety Reporting Portal submitted data. 19 The system shall allow access to AE and PC data by external systems, such as SAP Business Objects and SAS analytics software. 20 The system shall host rational questionnaires for non-adverse event or product complaint submissions, making these submissions available to other FDA information systems such as the Emergency Operations Network (EON) for processing. 21 The system shall authenticate internal users with FDA's Single Sign-On (SSO). 22 The system shall be able to export HL7 ICSR compliant XML files from report data Public Facing Web Submission System. 23 The system shall allow the Reporter to submit via modern web browsers on mobile and desktop systems. 24 The system shall allow the Reporter to create an account (including name, email address, etc.). 25 The system shall allow the Reporter to update account information as needed . 26 The system shall allow the Reporter to delete their account profile. 27 The system shall allow the Reporter to login in as a guest. 28 The system shall allow the Reporter to login to their accounts using verified credentials (email/password, Twitter, Facebook, etc.) 29 On devices with cameras, the system shall allow the Reporter to scan the Universal Product Code (UPC) barcode of a product within the reporting form to automatically populate product information such as ingredients, brand, etc. 30 The system shall provide UI controls to use mobile device camera hardware to take pictures of products and symptoms within the reporting form. 31 The system must provide UI controls that autocomplete fields with known lists of values . 32 The system shall allow intuitive UI controls for the Reporter to browse all large LOVs and make selections, such as product names, ingredients, and symptoms from controlled vocabularies . 33 The system shall allow the Reporter to upload additional items (pictures, pdfs, etc.) to the report. 34 The system shall allow the Reporter to input data via device supported voice recognition. 35 The system shall allow the Reporter to create a follow up report to provide updated or new report information. 36 The system shall allow the Reporter to save a draft report. 37 The system shall allow the Reporter to view draft and submitted reports. 38 The system shall ask the Reporter to read and accept or reject the Terms and Conditions. 39 The system shall send a notification to Reporter confirming account profile setup. 40 The system shall send notification to Reporter confirming report submission, including a report identifier for correspondence with FDA. 41 The system shall allow the User to manage submitter AE accounts (i.e. password reset and other administrative items). 42 The system shall support the hosting of multiple adverse event and product complaint report rational questionnaires, making submissions available to CAEMS for processing. 43 The system shall allow the Reporter to create a new voluntary Adverse Event (AE) or Product Complaint (PC) report for dietary supplements, foods, infant formula, or cosmetics, enforcing validations and displaying prompts appropriate for that context. (Reporter, consumer injured, products, and AE or complaint narrative, information, etc.) 44 The system shall allow the Reporter to create a new mandatory Adverse Event (AE) report for dietary supplement products, enforcing validations and displaying prompts appropriate for that context. SYSTEM BUSINESS ADMINISTRATION FEATURES AND FUNCTIONALITIES 45 The system shall allow users to manage synonym lists or other data for use by the auto-coding functionality to adjust its performance or account for new values in the standardized data (updates to product dictionaries, changes in the MedDRA values, etc.) 46 The system shall track business metrics for the case management workflow (case load for records management users, time taken for major workflow steps, etc.) 47 The system shall allow read-only users to view case information (i.e. case summary, product information, AE/PC information, outcomes and safety review, etc.) 48 The system shall allow the User to conduct coding and standardization dictionary management for product dictionaries and controlled vocabularies (MedDRA, etc.), including importing product data from external FDA or 3rd party sources (e.g. NIH Dietary Supplement Label Database). 49 The system shall allow the assignment of roles based permissions and functions. 50 The vendor shall perform cleanup of legacy data necessary to migrate CAERS case records to new COTs pharmacovigilance product. 51 The system shall migrate case data from the legacy CAERS to new COTS pharmacovigilance product. 52 The vendor shall provide user training for 15 users, across the user roles expected to be needed by CFSAN. 53 The system shall allow the user to track and monitor each case throughout the workflow. RECORDS MANAGEMENT AND WORKFLOW FEATURES AND FUNCTIONALITY 54 The system shall adhere to best practices in UI design to minimize data entry effort (minimize number of clicks or steps required to enter AE and PC data, support tabbing, etc.) 55 The system shall determine whether the new report data belongs to an existing case to prevent duplicate cases from being created and to keep all reports about one event and consumer injured together. 56 The system shall provide UI controls for RM users to search for duplicates and to manually merge cases when cases regarding the same adverse event and consumer injured are discovered. 57 The system shall allow Records Management User to manually create new adverse event cases. 58 The system shall allow the user to scan paper submissions using OCR configured to minimize RM time by adding page numbers, case identifiers, and other data to document scans. 59 The system shall hold contact information for other regulatory organizations, and be able to send reports not applicable to CFSAN to the correct organization. 60 The system shall auto-code case data to standardize symptoms and products and their associated information (brand names, ingredients, FDA categorization attributes, etc.) 61 The system shall provide UIs for verifying the auto-codings done by the system for case records created from electronic data sources. 62 The system shall provide UIs to allow the management of case related files (scans of paper reports, medical records, attachments to electronic submissions, reporter correspondence, etc.) 63 The system shall allow the population of all AE data (relating to the reporter, consumer injured products, AE or complaint narrative, etc.) at the report and case level, where appropriate. 64 The system shall allow the User to manually associate standard product data from controlled dictionaries (product names, firms, ingredients, label images, etc.) 65 The system shall allow the user to manually associate MedDRA codes with a report. 66 The system shall provide the User UI controls that autocomplete all data entry fields for which list of values are known (ingredients, firm names, MedDRA terms, etc.) 67 The system shall provide functionality for records management user to QA a created or updated case before being made available for safety review workflow. 68 The system shall allow the assignment of cases and reports to records management users, for data entry, product and symptom auto-code verification, and other records management functions, from all sources of AERs. 69 The system shall provide UI controls for safety reviewers to add comments and conclusions to a case from a safety reviewer perspective (likelihood of causality, etc.) In addition, the COTs tool must be capable of complying with the following 508 Standards: SECTION SUBSECTION STANDARD DESCRIPTION 1194.21 a, b, c, d, e, f, g, h, i, j, k ,l Software applications and operating systems 1194.22 a, d, e, f, g, h, I, j, k, l, m, o, p Web-based intranet and internet information and applications 1194.41 a, b, c Information, documentation, and support. Capability statements must demonstrate the ability to meet the minimum requirements outlined above. The vendor must identify whether their proposed COTS product is capable of meeting the requirements out of the box, via configurations, or customizations. The contractor shall also provide the following Business Information for both the seller and manufacturer of the product (if different): 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. SUBMISSION INSTRUCTIONS Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses shall be limited to 15 pages. Responses must be received in writing, by no later than May 9, 2016, 4:30 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Jody OKash at Jody.OKash@fda.hhs.gov.