Over the last few years the global regulatory authorities have been mandating the public disclosure of protocol registration and trial results in an effort to provide greater transparency to the public at large. In the USA, life sciences companies are required to publish to clinicaltrials.gov. In Europe, the EMA have established the EudraCT module and will make summary clinical trial results publicly available through the EU Clinical Trials Register (EU CTR). Each registry is quite different and requires a large number of rules to be applied. Further, it is necessary to update each registry as a clinical trial progresses. Manual, labor-intensive processes exacerbate the challenge. Constant changes in the regulatory environment and the emergence of new registries make it even more difficult to stay on top of current regulations.
LifeSphere Trial Disclosure™
LifeSphere Trial Disclosure is an advanced clinical trial disclosure solution that enables life sciences organizations to efficiently manage clinical trial registration and reporting of results to public registries. It supports the complete submission process including the collection of required submission data, review by stakeholders, application of registry specific validation rules and the generation of the compliant submission files while enabling ongoing updates throughout the duration of the study.
LifeSphere Trial Disclosure allows users to easily plan, prepare and submit trial registrations and report results to registries such as EudraCT and Clinicaltrials.gov, ensuring consistency of the published data. It offers a single platform to manage all registrations worldwide, re-using the data entered once for multiple registrations and delivering submission ready XML files or PDF reports.
Available on the cloud, any changes to the registries business rules can be made immediately available for download, ensuring you can remain compliant. Reports, real-time metrics and dashboards give users insight into the worldwide status of all their registrations while the system’s planning functionality ensures that none are missed.