Virtual payment solution to clinical research participants and related services to its Members and Affiliates.
- Products will consist of core software and mobile apps,digital wallet or token system, and system interface used to track funds (“Products”).
a. Provide a centralized, automated payment management platform that enables the administration, tracking, and distribution of participant payments, incentives, stipends, and reimbursements.
b. Support multiple payment methods, including but not limited to reloadable prepaid cards, virtual payment cards, Automated Clearing House (ACH) transfers, electronic vouchers, gift cards, digital wallets, and other commonly accepted electronic payment solutions.
c. Support participant payment programs and remote participant engagement while maintaining participant confidentiality and protecting personal identifiable information.
d. Provide travel reimbursement functionality, including support for transportation-related expenses and the ability to upload, store, and manage receipts and supporting documentation.
e. Enable Institutional Participants to monitor and manage study budgets, participant compensation, reimbursement activity, project expenditures, and financial performance at the participant, study, department, and institutional levels.
f. Support real-time tracking, monitoring, and reporting of IRS 1099-reportable payments and provide reporting capabilities necessary to assist Institutional Participants with tax reporting requirements.
g. Provide administrative tools that allow authorized users to reverse payments made in error, issue replacement payments, unlock participant accounts, recover unclaimed funds, and manage other payment exceptions as long as they are requested within a reasonable time frame (e.g. a maximum of 90 days).
h. Support configurable multi-level approval workflows, role-based access controls, segregation of duties, and other internal control mechanisms designed to ensure proper authorization and oversight of participant payments.
i. Support integration with institutional systems, including but not limited to Enterprise Resource Planning (ERP) platforms, Clinical Trial Management Systems (CTMS), authentication services, Single Sign-On (SSO) solution, and other institutional technologies.
j. Maintain compliance with applicable federal, state, and industry security and privacy standards, including HIPAA requirements, and provide comprehensive audit trails, fraud prevention controls, and data protection safeguards.
k. Provide configurable dashboards, reporting, analytics, and data export capabilities that allow Institutional Participants to monitor participant activity, study expenditures, payment status, and program performance.
l. Payment Methods and Participant Incentive Management
i. Provide Institutional Participants with the ability to administer participant incentive and reimbursement programs through a centralized platform.
ii. Support payment instruments that may be used for point-of-sale, internet, mail-order, and telephone transactions, where applicable.
iii. Allow Institutional Participants to reload, reuse, and manage participant payment accounts, cards, or other payment methods across single or multiple research studies.
iv. Allow authorized users to create, modify, suspend, cancel, replace, and reissue participant payments individually or in bulk.
v. Provide toll-free and online support for reporting lost, stolen, expired, damaged, or compromised payment instruments.
vi. Provide immediate cancellation of lost or stolen payment instruments and facilitate replacement processing within established service-level commitments.
vii. Allow Institutional Participants to customize participant payment instruments with approved institutional branding, including logos and program identifiers, where applicable.
viii. Allow authorized users to immediately deactivate participant payment accounts, cards, or payment methods when necessary.
ix. Provide automated notifications and reporting regarding participant payment instruments that are approaching expiration.
x. Support individual and bulk activation, funding, and distribution of participant payment instruments.
m. System User Interface and Administration
i. Provide a secure, browser-based administrative platform that does not require local software installation and is accessible through standard web browsers.
ii. Allow authorized users to create, update, replace, suspend, reactivate, and manage participant accounts and payment profiles.
iii. Support configurable and user-defined data fields for participant, study, investigator, department, project, and institutional information.
iv. Allow participant enrollment and payment administration using minimally necessary information when required by Institutional Participants.
v. Provide configurable workflows, administrative controls, and system guidance to support account setup, payment processing, study management, and ongoing system administration.
vi Provide real-time confirmation of participant enrollment, account creation, payment issuance, payment modifications, and transaction processing activities.
vii. Support role-based security permissions and configurable user access controls.
viii. Provide visibility into system audit logs and transaction history for authorized administrators.
ix. Support participant eligibility validation, milestone-based payment schedules, and study-specific payment requirements.
x. Provide secure web-based enrollment, payment administration, and account management capabilities that support efficient participant and study administration.
xi. Provide timely refunds to Institutional Participants when requested in writing (e.g., within 30 days)
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