Real-world studies in complex treatments

Cisiv’s electronic data capture (EDC) platform, Baseline Plus, is built specifically to meet the complex needs of post-approval research. Its flexible structure is well suited to oncology studies as it can adapt to very complex patient lifecycles and offers an intelligent and engaging online tool for both physicians and patients to enter study data.

A leading global biopharma company needed to generate real world evidence on its oncology drug, to meet the needs of regulatory approval as well as establish health economics outcomes. Meeting the evidentiary needs of multiple stakeholders can be complex and expensive but Baseline Plus supported a lean process and remote management for data collection and analysis, which made the study highly cost effective.

Despite the complexity of the patient pathway, Baseline Plus was able to streamline data capture from both patients and physicians, reducing stakeholder burden and creating a very positive site experience.


The leading biopharma company had launched a novel therapeutic medicine for cancer treatment. Although it had proven effective, the drug was missing key health economics data to enable access for patients who could benefit from it. The company faced the challenge of obtaining reimbursement in numerous healthcare systems, including in the UK.


Baseline Plus was deployed to support a health economics study in 163 sites and 1583 patients across 9 countries. The study supported a complex patient lifecycle and the features and functionalities built into Baseline Plus enabled the achievement of high quality data without high data management costs.


The data from this study enabled the biopharma company to successfully obtain reimbursement in many countries. It supported a broadening of the therapy’s reimbursement case and increased access for many more cancer patients.

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