Cloudbyz CTFM: Agreements, Amendments and Supporting Documents Attached Where They Belong

Smit Shah
CTBM

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Every payment to a site rests on documents: the signed agreement, its amendments, receipts for pass-through costs, tax forms and approvals. Cloudbyz CTFM lets teams attach agreements, amendments and any supporting documents directly to the site, budget, invoice or payment they support, so the evidence for every number is one click away. It suits large pharma, global multinationals, biotechs, CROs and device companies.

How it works today

  • Signed agreements sit in a contracts system or shared drive.
  • Amendments are emailed and saved wherever the recipient chooses.
  • Receipts for travel and pass-through costs arrive as email attachments.
  • When an auditor asks why a payment was made, someone assembles the evidence by hand.

Why it matters

  • Agreements are required records. 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), and in the EU, essential documents must be available at all times (EMA TMF guideline).
  • Financial disclosure. In the US, investigator financial disclosure must be collected before participation, and FDA may refuse to file an application without it (21 CFR 54.4).
  • Payments need support. Auditors expect pass-through costs to be backed by receipts, and fees by the agreement version in force at the time.

What to attach, and where

Document

Attached to

Signed site agreement and amendments

Site agreement record

CRO and vendor MSAs and change orders

Vendor agreement record

Budget approvals and rate justifications

Site budget

Receipts for pass-through costs

Invoice line

Tax forms and bank confirmation letters

Payee record

Financial disclosure forms

Investigator record

Today versus Cloudbyz CTFM

Question

Today

Cloudbyz CTFM

Which agreement version applied?

Search the drive

Attached to the agreement record, by version

What supports this payment?

Assemble by hand

Attached to the invoice and payment

Where is the bank letter?

Someone's email

On the payee record

What changes by department

  • Finance: every payment is supported by attached evidence.
  • Contracts: agreement versions sit with the budget they set.
  • Clinical operations: no hunting for documents during audits.
  • eTMF teams: with Cloudbyz eTMF on the same platform, executed agreements can also be filed to the TMF.

How Cloudbyz CTFM does it

Cloudbyz CTFM, built natively on Salesforce, lets users attach agreements, amendments and other supporting documents to the site, agreement, budget, invoice, payment or payee records they relate to, alongside email trails. Book a demo or visit cloudbyz.com.