Tufts CSDD estimates the mean direct cost of a Phase II trial at $23,737 per day, and $55,716 per day for Phase III (Tufts CSDD, 2024). A 2022 Tufts CSDD survey found that 76% of protocols now have at least one amendment (Tech Funding News, citing Tufts CSDD).
For a biotech, those numbers land differently than at a large pharma company. Finance teams are small, most work is outsourced to CROs and vendors, and every month of spend is measured against cash runway. What helps most is visibility: knowing what has been spent, and what is coming next, for each study and across the portfolio. Here are seven areas where that visibility makes a difference.
|
Area |
How visibility helps |
|---|---|
|
1. Set-up from templates |
Each study's budget is in the system from the start |
|
2. CRO and vendor spend |
Spend is seen against each vendor's budget |
|
3. Change orders |
Their impact is visible before they are agreed |
|
4. Cash and runway |
Spend is seen by month against funding |
|
5. Site payments |
Paid and pending amounts are clear to sponsor and site |
|
6. Upcoming finance events |
Payments, invoices and milestones coming due are visible ahead |
|
7. Study and portfolio reporting |
Spend and forecast are seen per study and across studies |
Starting from budget templates and rate cards, rather than building each study from scratch, gets a small team running quickly. Set-up time is a real cost when the finance team is one or two people.
Most biotech trial spend goes through CROs and vendors. The platform should hold each vendor's budget and show spend against it, so the sponsor has its own view rather than relying only on vendor reports.
With most protocols amended, change orders are certain. A forecast that shows whether a change order is needed, and roughly how much, gives a small team a basis for negotiation.
Biotechs plan around cash, not only budget. Knowing when money will be spent, by month and by vendor, supports runway planning and funding decisions.
Experienced sites prefer sponsors who pay on time. Paying from completed visit data, with contracted terms applied, makes payments accurate and faster.
Milestone payments, invoices coming due, holdback releases and expected change orders are easier to plan for when they are visible ahead of time. Seeing these upcoming events for each study, and rolled up across the portfolio, helps finance plan cash and helps clinical operations avoid surprises.
Boards and investors ask where the money has gone and where it will land. Spend and forecast by study, phase and vendor should be a report, not a project.
Cloudbyz Clinical Trial Financial Management (CTFM) is built natively on Salesforce and is modular, so a biotech can start with CTFM alone or alongside Cloudbyz CTMS and EDC on the same platform. It supports study and site budgets, MSAs, rate cards and budget templates, visit-based invoicing, workflows and approvals, and portals for sponsors and sites.
The CTFM forecasting module forecasts spend from actual study progress and can show whether a change order is needed, how much, and which regions and sites are affected. Spend, forecasts and upcoming finance events can be viewed for a single study or across the portfolio. The Financial Navigator, an Agentforce agent, answers budget and payment questions in plain language and surfaces the gap between what sites have been paid and what has been received, read-only. Set-up time depends on scope and configuration.
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