Ease of use is a major consideration for electronic data capture (EDC) systems in clinical trials. Medrio believes its software can make new project set-up simpler, a premise recently put to the test by Curem Research.
Located in Michigan, US, Curem Research provides clinical research services to biotech and pharmaceutical companies. Its services include site monitoring and management, project and data management, medical writing, pharmacovigilance and statistical support.
Recently, Curem Research piloted a new electronic data capture (EDC) system that has been designed by Medrio to shorten the time of database build, allow greater control of the database and offer a cost-efficient alternative to traditional EDC systems.
In this instance, the project was a phase 2a clinical trial in 182 subjects across 11 sites. Curem data managers were challenged to complete case report form (CRF) design for 23 unique CRFs, build the study database, program edit checks, and complete user acceptance testing (UAT) to achieve a live database within eight weeks in a new electronic data capture system (EDC).
Data managers were operating within the Medrio system upon completion of onsite two-day training
Prior to utilising Medrio’s eClinical solution, previous systems required external EDC vendor programmers to design, build and program within their EDC system. The flow of information was directed through the EDC project manager. The output specifications, which required sign-off, were provided in programming language. Overall this added time, costs and interpretation issues.
Curem completed the review and demonstrations of several available EDC systems. The Medrio system was chosen because its user-friendly features allowed Curem’s data managers to complete the build and program edit checks without the involvement of programmers. Data managers were operating within the Medrio system upon completion of onsite two-day training.
cut out the middlemen
After consultation with the sponsor and the Curem project manager, the CRFs were designed within the Medrio EDC system. The CRFs were generated in PDF format by the EDC system and distributed for review, which was more efficient than the previous method of designing CRFs in Word to provide to the EDC vendor programmer for build. The ability of a data manager to design the CRFs allowed for a seamless build process as he had a greater understanding of the protocol than the programmer.
After CRF design approval, edit checks were written within an Excel template and provided to the sponsor for review. Edits were written using the actual variable names, instead of SAS annotated labels, to allow for easier understanding by clinical personnel not trained in programming language. Internal UAT was performed by a second data manager and project manager utilising the test plan generated from the edit check spreadsheet.
Curem had two rounds of UAT amounting to a total of 14 hours. A similar study conducted by Curem with a traditional EDC vendor had a total of 77 hours billed to UAT, which included four rounds of testing. As a result, Curem delivered a live database to the sponsor in seven weeks (a large CRO had quoted 10 weeks). The study was started two weeks ahead of schedule and enrolment completed three weeks early.
Curem’s clinical research associates completed final monitoring within two days of last patient last visit (LPLV). All queries were resolved, casebooks signed and the database locked within seven working days of LPLV. This was five weeks ahead of the timeline quoted by the larger CRO.
The sponsor selected Curem and the Medrio eClinical system due to the efficiencies of the internal build, control of the database, and quick turnaround for build and database lock; it also offered a significant saving compared with other CRO quotes.
In this instance, the Medrio EDC system provided a low cost, effective system for capturing data in clinical trials. Subsequent studies in Medrio have offered additional efficiencies that allow Curem to continue to exceed expectations with customers.
The employment of an EDC system in early phase studies has important benefits for the study’s execution and is becoming more of a requirement from a regulatory standpoint. The success of the entire clinical development program depends in large part on the ability promptly to assess safety and efficacy of a drug. Critical decisions need to be supported by near real-time data collected through a validated and 21 CFR Part 11 compliant EDC system.
The employment of an EDC system in early phase studies has important benefits for the study’s execution and is becoming more of a requirement from a regulatory standpoint
Small biotech companies, however, need an EDC tool that provides the desired functionality, but at a fraction of the cost of the major EDC vendors. Tool selection, similar to CRO selection, needs to meet their specific needs.
The company Cd3 often works with small biotech firms in assisting with the EDC system development and implementation. President and ceo Bill Baker, a veteran of the industry with extensive expertise in data management, reviewed more than 70 products while at Bayer Pharmaceutical, where he was involved in selecting that company’s next generation EDC platform. The important qualities he identified were: flexibility, scalability, ease of use, IT independence, rapid implementation, data accessibility, easy report generation and cost effectiveness. After evaluating many commercially available platforms with his team he found these qualities in Medrio and started a collaborative relationship that has benefited many of its small biotech clients.
Since 2008, Cd3 has worked with Medrio as both a power user and beta tester and in this role has helped develop the platform and add new tools. In the past 24 months Cd3 developed 10 EDC studies using Medrio, nine of which have reached Clean Database. Four sponsor-based (EDC/Medrio) audits passed with no critical findings on Cd3’s CFR 21 Part 11 compliant and validated systems and processes.
