What’s Next? In the aftermath of a turbulent 2020, in which the overall industry perception of the decentralized clinical trial (DCT) approach transitioned from being “promising but still largely experimental” to “a new-normal paradigm for the industry to adopt,” we have been considering “what’s next?”
Decentralized Clinical Trials (DCT) Monthly Blog – December 2020
Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year. As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to …
Bioanalysis of Biologics: Understanding the Role of LC-MS
As biologics-based therapies have expanded, LC-MS is increasingly applied to support quantitative bioanalysis to detect diverse peptides and proteins. LC-MS can offer a few notable advantages compared to the traditional approach for quantification with ligand-binding assays (LBAs), but is typically thought of as a complementary approach.
IND-enabling Programs for Gene and Cell Therapies Webinar Questions
Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from our recent presentation. For more information on our solutions, visit our Cell & Gene Therapy Education Center here.
The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions
As COVID-19 was declared a pandemic, our Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
Brexit: leveraging the mutual recognition agreement to mitigate risk with commercial drug product release testing (updated 08-20)
The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit. …
Establishing Control Over the Manufacturing Process and the Quality of your Biologic
When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control …