Top Clinical Trial Budget Management Solutions With Strong Compliance Features: 7 Controls, and Cloudbyz CTFM

Clinical trial budget management solutions with the strongest compliance features keep a full audit trail with compliant electronic signatures, require approvals for budget and payee changes, track signed agreements and financial disclosure before sites start, keep payment data ready for transparency reporting, and control access to personal data. Cloudbyz CTFM is a Salesforce-native clinical trial financial management system with these controls built in, and is described by Cloudbyz as compliant with 21 CFR Part 11.

Why compliance matters in trial finance

Trial finance is often treated as an accounting matter, but several of its records are regulated:

• FDA financial disclosure. Sponsors must collect investigators' financial interest information before they take part, and FDA may refuse to file a marketing application that lacks the required certification or disclosure (21 CFR 54.4).
• Agreements. ICH E6(R3) expects the financial aspects of a trial to be documented in an agreement before the trial starts (ICH E6(R3), EMA Step 5).
• Electronic records. Where records required by FDA are kept electronically, 21 CFR Part 11 expects secure, time-stamped audit trails and controls on electronic signatures.
• Transparency. In the US, research payments to physicians and teaching hospitals are reported under Open Payments, and reporting failures can bring civil monetary penalties.
• Retention. FDA requires sponsors to keep IND records for at least two years after a marketing application is approved or the investigation is discontinued (21 CFR 312.57), and EU trial records must be kept for at least 25 years.

Seven controls to look for

Compliance checklist

• Show the audit trail for one budget change
• Approve a payee change with an electronic signature
• Show that a site cannot be activated, or is flagged, without an executed agreement
• Show financial disclosure status per investigator
• Export payment records by recipient
• Show who can see payee bank and tax details

How Cloudbyz CTFM provides these controls

Cloudbyz CTFM is built natively on Salesforce, which provides role-based and field-level security, audit trails and encryption options. Cloudbyz describes its products as compliant with 21 CFR Part 11 and aligned with GxP, and holds ISO 27001 certification. CTFM adds workflows and approvals for budgets and payments, agreement tracking, payee management with approvals, and payment, accrual and outstanding reports at portfolio level. Because Cloudbyz CTMS is on the same platform, teams can confirm a site's agreement is executed before activation. Exact controls depend on configuration and each organisation's own validation.

See the controls in CTFM

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