Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.
The objective of this study was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device. The results supported the validity and reliability of the new tablet-based electronic Columbia-Suicide Severity Rating Scale and allow its inclusion in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data.
A biopharmaceutical company wanted to determine whether patients treated with an oral inhibitor of phosphodieasterase-4 (PDE-4) would show improvement in signs and symptoms of PsA. They used ERT eCOA tablets to collect data about patient symptoms as observed by physicians through the ACR assessment which was used to assess efficacy. Results showed reduced monitoring time and costs, decreased time to database lock, and FDA approval.
This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics to craft the best clinical supply management strategies for their multiple, complex clinical trials.
Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies. These tools can help you improve the efficiency in which you close out and lock your clinical database.
A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing.
Accelovance is a global company that oversees hundreds of clinical trial activities. Manual data entry was taking up hours of employees' time as well as adding unnecessary complexity and risk to the clinical trial process. In this case study, learn how the move to automation saved 90 operational hours per month, enabled staff to focus on other strategic endeavors, and provided actionable data that led to winning new business for the company.
What do you do when there are large discrepancies in your data? Learn how one leading global pharmaceutical company overcame this challenge. You’ll gain insight into how a new study design, that leveraged ERT Respiratory solutions and Centralized Data Surveillance, improved statistical outcomes and reduced site data quality issues, generated higher-quality data for regulatory submission, drove data acceptability to 95%+, and achieved database lock on schedule.
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