Conducting clinical trials for rare, debilitating diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while not typical, might help to reach these patient populations who otherwise would struggle to participate in and comply with clinical trials. However, implementation of this strategy is challenging because of many reasons such as the logistical considerations and regulatory requirements regarding patient confidentiality and quality control. Recently, Bioclinica collaborated with a sponsor to successfully ship study drugs directly to patients.
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.
During various deals, the M&A team in the Raymond James Nashville offi ce relied on cumbersome manual processes for due diligence. For instance, to handle the question and answer process, the deal team used traditional met hods, conducting diligence via email and with Microsoft Excel® spreadsheets. Buy ers would create individual spreadsheets with different tabs for each category of questions, and submit them to Raymond James’s deal team. The deal team members then manually tracked the status and response of each question to en sure they sent the correct answers to the right bidder.
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.
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Pharmaceutical companies are increasingly outsourcing product production to contract manufacturing organizations (CMOs). Doing so enables them to focus more of their resources on developing innovative new products and less on non-core, commodity activities, such as manufacturing. While this has been a boon for CMOs, it also creates new challenges as both their client base and related production demands rapidly diversify. Just staying on top of it all can be a big job.
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