About the company
The company is one of the 20 largest pharmaceutical companies worldwide. This success story focuses on its immunology and respiratory therapeutic area, which runs several multi-country Phase 3 programs at several hundred investigator sites in more than 20 countries. Most of these trials run for several years, so their site budgets are renegotiated several times over the course of a study.
Global clinical operations designs each study and sets the framework for site contracts, including the fair market value ranges for visits and procedures. Within that framework, the country clinical operations teams negotiate clinical trial agreements and investigator grants with their sites, and a contracting team in legal reviews every agreement. R&D finance owns the accruals and forecasts of the therapeutic area, and its leadership team reviews the trial budgets every quarter.
The challenge
Site budgets were negotiated in local templates and kept in regional Excel files. That worked for single studies, but not for a growing portfolio. Two weeks before every quarter-end, R&D finance asked each country team for its latest budget file and site payment list. The files came back in different layouts and currencies, and a study manager in global clinical operations merged them by hand before finance could book its accruals.
Protocol amendments revealed the limits of this setup most clearly. When an amendment added a visit or a procedure to the schedule of assessments, every country had to recalculate and renegotiate its site budgets, and it took weeks to know what the change would cost across the program. New sites were usually priced from the last comparable study, because there was no shared benchmark for each visit or procedure.
No consolidated view of what each site had earned and what had been paid
Site invoices were checked against the agreements by hand, country by country
Accruals were based on estimates and reconciled once a quarter
Pricing an amendment across all sites took weeks
The solution
The therapeutic area wanted one system for its site budgets that works alongside its CTMS and its payment provider instead of replacing them. It chose the Trialytix Sponsor Suite and works with all four of its modules.
Site & CRO Budgets: One budget structure for every site, with the visit schedule, invoiceable procedures, local currency and overhead. Budget versions are negotiated with each site up to the final version in the clinical trial agreement.
Service catalogue: Every site in one directory, with costs and benchmarks by site and region for each visit and procedure. Country teams price new sites from the therapeutic area’s own history.
Invoice Tracking: Every site invoice is recorded per position and month against the agreed budget and flagged when it is off budget. Month-end accruals follow from planned or confirmed visits.
Scenario Planning: Amendments, enrollment changes and additional sites are priced across all sites before they are approved, with forecasts to match.
Reports: Insight Reports show forecast at end, burn vs. progress and health status for every study, and Global Reports put all studies of the therapeutic area side by side. Spend Projection turns the forecasts into R&D spend by quarter.
The rollout
The rollout started with two active Phase 3 studies. Their site budgets and payment histories were imported in a structured format and checked in joint QA rounds before user acceptance testing. IT connected Trialytix to the company’s single sign-on, and access was set up per study: edit rights for the country teams, view rights for leadership.
Clinical operations and finance were trained together, so both teams learned the same screens and the same terms. The country teams joined in waves, and the other studies of the therapeutic area followed once the first two had closed a full quarter in the system.
How the teams use Trialytix
All teams work on the same studies, each with the rights its role requires.
Country clinical operations teams negotiate site budgets and investigator grants from the benchmarks, record site invoices and answer payment queries from sites directly.
Global clinical operations follows enrollment and completed visits per site and prices a delay or an additional site in the study team meeting.
R&D finance books month-end accruals per study and site, compares budget with actuals and locks every closed month.
Legal reviews each clinical trial agreement against the final budget version, so the agreement and the budget always match.
The therapeutic area leadership team goes through the Global Reports in its quarterly business review.
The result
Clinical operations and R&D finance now work from the same numbers. Quarter-end no longer starts with collecting spreadsheets from the regions, and reconciling accruals takes around a quarter less time than before. Questions about a site’s payment status are answered in the system, often while the site is still on the phone.
When a protocol amendment is proposed, its cost across all sites is known before it is approved, and the decision rests on a priced scenario instead of an estimate. As a result, budget discussions with leadership are shorter and more factual. The quarterly review now starts from the Global Reports, not from a slide deck built the night before.