CARDIORENTIS AG v IQVIA LIMITED

A contract research organisation’s obligations are determined by the services undertaken, the contractual standard of care, and the trial documents defining its procedures. A high incidence of eligibility deviations does not itself establish breach, particularly in an acute clinical trial where investigators control enrolment. The claimant must identify breaches and prove their causal effect.

Source data verification is not a warranty of data accuracy, and must be performed in a timely manner. A claim for wasted expenditure requires proof that expenditure was rendered futile by breach. Benefits received must be taken into account. Trial results which are reliably negative are not wasted merely because they do not support regulatory approval. A sponsor’s contractual ownership of trial data may entail continuing access to the electronic trial master file.

Cardiorentis engaged IQVIA to provide contract research organisation services for the TRUE-AHF Phase III clinical trial concerning ularitide. The parties’ agreements covered monitoring, medical support, source data verification, quality procedures and payment.

Cardiorentis alleged that IQVIA’s defective training, monitoring, reporting and blind data review caused the enrolment of ineligible patients and rendered the trial unreliable. It claimed damages for wasted expenditure and an injunction for access to trial data. IQVIA counterclaimed for unpaid invoices and performance-related fees.

The proceedings were consolidated after IQVIA commenced its claim for payment and Cardiorentis brought its substantive claim. The central issues were whether IQVIA had breached its contractual obligations, whether any breach caused material unreliability or wasted expenditure, whether Cardiorentis was entitled to access to the trial data, and the amount due under the counterclaim.

1. Contractual obligations. IQVIA was required to perform the agreed services with the standard of care customary in the contract research organisation industry and with reasonable skill and care under section 13 of the Supply of Goods and Services Act 1982. IQVIA had not undertaken responsibility for remote medical monitoring of the electronic database.
2. Monitoring and eligibility deviations. The occurrence of eligibility deviations did not, without more, establish breach. There was no accepted benchmark for an acute trial of this type, and investigators retained responsibility for determining eligibility. Cardiorentis failed to prove that any identifiable or significant number of eligibility deviations resulted from IQVIA’s breach. Limited breaches did not have material causative significance.
3. Source data verification. The GSA required 100% source data verification of the relevant eCRF data, performed in a timely manner. That obligation was not a warranty that every data point was accurate, because source data could itself be inaccurate and the data set changed over time.
4. Blind data review. The review was imperfect and less organised than recommended, but it was undertaken conscientiously and blind to treatment allocation. Decisions concerning the interpretation of inclusion criterion 6 and the use of BIOS listings were reasonable and did not deprive the per-protocol population of usefulness.
5. Reliability and wasted expenditure. The trial reliably produced negative results. The cardiovascular mortality endpoint was unaffected by excluding ineligible patients. The short-term endpoint remained far from the prespecified effect size and statistical significance even on analyses excluding ineligible patients. The expenditure was therefore not shown to have been wasted. The principles in Robinson v Harman, Anglia Television v Reed, The ‘Mamola Challenger’, Yam Seng and related authorities applied.
6. Access to data. Cardiorentis was entitled to access to the electronic trial master file. That right followed from the GSA, the regulatory framework and Cardiorentis’s contractual ownership of the trial data. Clause 8 regulated delivery up of retained materials and did not deprive Cardiorentis of continuing access.
7. Counterclaim. IQVIA failed to prove entitlement to the performance payment for achieving 90% data clean. It also failed to deliver accurate top-line results within the contractual period and was not entitled to that milestone payment. It otherwise established entitlement to recover €4,509,244.47, subject to further submissions on interest.

Not an appeal. The judgment determined consolidated first-instance proceedings in the Commercial Court.