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 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.
A leading global pharmaceutical sponsor began a program of clinical trials to discover if a new bronchodilator could demonstrate superior and sustained lung function for patients with COPD. Learn how integrated Respiratory, eCOA, Cardiac Safety and Centralized Data Surveillance solutions enabled the sponsor to prove efficacy and safety during the program, helping to secure new drug approval from U.S. and European regulatory bodies.
Premier Research, a leading clinical development service provider, struggled with their time-intensive manual data entry process. In this case study, learn how the company implemented a technology-based solution that was flexible enough to adapt to all their trial needs, including the improvement of employee productivity and trial data accuracy, and the replacement of paper-based reports which led to reduced inefficiency and better communication among stakeholders.
It is common to have a limited amount of API in the early phase of drug development, which often impedes the rapid progression of drug development. This article describes a new approach that enables the use of industrial scale machines from the very beginning and has resulted in high quality output for cGMP processes, and optimized the yield of small batch size production.
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