Case Study
Executing Data Management Solutions for eSource-based Workflows in Phase 1 Trials
Project Background Our client, a top 20 pharmaceutical company has a portfolio extending across rare diseases, oncology, and immunology indications. The client’s longstanding partnership with eClinical Solutions encompasses both adoption of elluminate Clinical Data Cloud, and biometrics services outsourcing for over 15 Phase 1 trials.
Company Profile
The client planned a double-blind, placebo-controlled dose escalation Phase 1 study. Rather than deploying a traditional electronic data capture system, the clinical CRO (Contract Research Organization), working directly with its own network of Phase 1 units was using an eSource tool to collect data directly from the sites. The client approached eClinical Solutions for a solution combining elluminate and eClinical Biometrics Services to handle the data management for this study to tight timelines.
■ Headquartered in Europe
The advantages of adopting eSource include reduced cycle times, improved data quality, and greater potential for remote monitoring.
Products Utilized
In the context of greater trial decentralization, workflows for effectively handling eSource approaches are increasingly vital.
Challenges The central focus of Phase 1 dose escalation trials is assuring the safety of patients in determining the Maximum Tolerated Dose with investigators and sponsors reviewing all data at defined points and documenting the dose escalation decision. This particular Phase 1 trial involved over 50 patients across several cohorts with more than 5 external data sources. The assertive timelines incorporated data review meetings every 3 weeks.
“ With the trend towards decentralized and hybrid trials, we would expect to see an increase in use of trials that use eSource.” Diane Lacroix VP, Clinical Data Management, eClinical Solutions
■ Top 20 Ranked Pharmaceutical Company in Revenue ■ 90,000+ Employees
elluminate Clinical Data Cloud Biometrics Services