Application Notes & Case Studies

1. How To Eliminate Custom Functions From EDC 4/20/2021

   Learn how companies like ICON, Alcon, and Bioforum – The Data Masters are building edit checks directly within the EDC, eliminating the need for custom functions. With the powerful rules engine in Vault CDMS, these companies are speeding clinical trials and supporting greater agility during study conduct.

2. Toolbox Medical Relies On WCG IRB’s Prompt, Personalized Expertise In An Unsettled Environment 4/20/2021

   During the last year, Toolbox Medical, Inc. has been exceptionally busy, helping clients develop COVID-19-related products. In fact, they launched at least six studies in January 2021 alone. As Toolbox’s client base and workload grows, it relies heavily on its long-time IRB partner, WCG IRB.

3. Real World Data: Extensive Searchable Selection Tables For Sites In A Study With 15,000 Patients 4/7/2021

   A top 5 Pharma company was collecting data for a global disease registry from over 10,000 patients. To avoid collecting “free text” they wanted the study sites to use extensive “pick lists”. These lists consisted of over 12,000 unique options so could not be just simple lists. Cmed was able to provide a solution that would enable site staff to review, filter and select the required option.

4. Effective Way To Ensure Early Statistical Deliveries 4/7/2021

   A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

5. Accurately Aligning Data Structures That Can Stand Up To Regulatory Scrutiny 4/7/2021

   A biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As the team started to plan their first Phase I study they realised that they wanted to align the data structures from both studies. By applying previous experience of rescue approaches for clinical data, Cmed built an encapsia database to meet needs for all prospective data.

6. Automatic Score-Based Treatment Path For Site Users 4/7/2021

   A biopharmaceutical company had a Phase II study with 300 patients in 5 countries. At a key point in the study each patient’s treatment path depended on a score calculated from data collected over the previous period. Cmed was able to provide them with a solution that would enforce a workflow to ensure the accuracy of the data used in the score calculation.

7. Sponsor Discovers Unique Study Design That De-Risks Clinical Trial And Optimizes Commercial Strategy 3/31/2021

   Da Volterra wanted to maximize the power of their clinical trial for scenarios with a smaller treatment effect, and were contemplating a Sample Size Re-estimation design. Unfortunately, with a strict enrollment limit of 1,100 patients, this particular study design produced only marginal gains in power over the fixed sample size design. By working with Cytel’s statistical consultants and their powerful new software platform Solara, Da Volterra was able to maximize the chance of a successful trial result with precise insight into the tradeoffs in speed, savings and success with a simple, low-risk trial design identified within hours.

8. Meridian Builds Robust Gene Therapy Research Program By Leveraging Advarra IBC Services 3/30/2021

   Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.

9. Leveraging A Central IRB Office To Improve Turnaround Times And Consistency 3/30/2021

   With over 100 sites in the Academic and Community Center Research United (ACCRU) research network, utilizing a central IRB office was essential to increase review consistency and turnaround times.

10. Unburdening Sites By Eliminating 98,166 Hours Of Redundant Training 3/24/2021

    The content of training required to conduct clinical trials can overlap significantly from study to study. A common frustration for clinical site teams is the required completion of training for a new trial that is identical, or nearly identical, to training they previously completed for another project. Check out this case study to learn more on how WCG Trifecta helped eliminate redundant training through a clinical qualification management system.