Featured Articles

1. Regulatory Forces Drive The Need For Advanced Planning In Study Initiation 11/10/2021

   Recent regulatory changes have established the need for advanced study planning, aligned study startup management, and cross functional coordination. Find out about these recent changes in the available article.

2. EU Set To Attract More Clinical Trials With Streamlined Submission Process 8/25/2021

   Patients can be assured that their prescribed medicine has been vetted for safety and efficacy by a long and arduous discovery process guided by governmental regulatory agencies. The European Union (EU) recorded a concerning 25% decrease in clinical trial applications (CTAs) from 2007 to 2011, and this downward trend has continued. Find out why.

    

    

3. Parallelization: Imperative To The Compression Of Clinical Trial Cycle Times 4/14/2021

   Study startup, the activities involved at the outset of clinical trials, remains highly inefficient and prone to bottlenecks and errors. Clinical trials that get off to a good start are more likely to execute well and finish on-time and on-budget – study startup is the Achilles heel of clinical trials. With unrelenting pressures to rein in budgets and cycle times the application of project management techniques to study startup holds the key to optimizing operational efficiencies and compressing timelines. The parallelization technique which represents the greatest opportunity to realize efficiency gains that are reproducible across all studies, and not just on an as-needed basis.

4. Exploring Clinical Trial Design And Data Collection In A New Environment 11/20/2020

   New research reveals that COVID-19 has accelerated adoption of decentralized approaches and remote data collection for clinical trials and that this transition that has come with both challenges and benefits.

5. Redefining Clinical Strategy With Scenario Planning 11/17/2020

   Key assumptions are made at the outset of setting up a clinical trial surrounding country and site selection. What if those assumptions shift? Do you know with a certain level of confidence how changes in those assumptions will impact the execution of the study? This is why scenario planning is so valuable, and critical to helping to manage the variability in clinical trial setup decisions.

6. The Time Is Now For Transformation In Clinical Data Collection 7/1/2020

   The latest platform for data collection and clinical trial management can help overcome barriers to implementing new data collection methods and digital strategies for clinical trials. 

7. Is Pharma Ready To Embrace Virtual Trials? 6/21/2020

   Now is the time for pharmaceutical companies to take a look at the best approaches for designing and implementing virtual clinical trials. Using a virtual approach to clinical trials has the potential to improve patient experience and data quality while also accelerating the time it takes to get new drugs on the market.

8. How Effective Are Clinical Study Startup Regulations? 5/25/2017

   The clinical trials sector is highly regulated, and justifiably so. Biopharmaceuticals that patients need and depend on must be safe and effective, which is why international regulations for Good Clinical Practice and an array of regulatory guidances zone in on how clinical trials should be conducted. But study startup (SSU), one of the most complicated and challenging parts of the clinical trials process, has surprisingly few guidelines.

9. Myopic Focus On Dashboards May Blur Clinical Trial Insights 5/25/2017

   There is intense pressure to speed clinical trials and restrain costs, and given the burden of this duality clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data - at a faster pace, while sponsors and contract research organizations (CROs) are looking for ways to incorporate business intelligence (BI) into the eClinical systems they are using to empower oversight—turning raw trial data into actionable information.

10. Alternative Fact: Site Identification Is Not Critical To Clinical Trial Efficiency 3/3/2017

    On the surface this may seem to have some validity, as sponsors and contract research organizations (CROs) often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data. Moreover, the practice of adding more sites per study than necessary and requiring each site to recruit fewer subjects per site is a standard, although questionable, risk mitigation practice. So how important can site identification be to the efficiency of clinical trials?