MAKE THE SWITCH TO ELECTRONIC DATA CAPTURE

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1 MAKE THE SWITCH TO ELECTRONIC DATA CAPTURE Sophie McCallum, Director of Operations, Clinovo

2 INTRODUCTION Electronic Data Capture (EDC) collects clinical trial data electronically rather than on paper. It is becoming an increasingly popular solution for streamlining clinical data processing. Studies suggest that using EDC systems drastically reduces data errors and speeds up the overall trial process, reducing clinical research costs by up to 20%. Clinical data quality is also dramatically improved when relying on EDC: According to the Regional Operations Manager at Eli Lilly in Canada, implementing an EDC system resulted in a 70 to 80% reduction in queries. However, the adoption of EDC (Electronic Data Capture) systems has remained slow in some segments of clinical research. According to Datamonitor, the market intelligence and data analysis firm, only 40% of Phase I clinical trials had adopted EDC by the end of % of Phase 2 clinical trials, 80% of Phase 3, 70% of Phase 4, and 5% of Others (non-fda regulated studies) are utilizing EDC systems. A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvement outweigh these difficulties. This paper aims at clarifying and facilitating the process of switching to Electronic Data Capture (EDC), with a focus on ClinCapture, Clinovo s Electronic Data Capture (EDC) system. We listed below some of the essential points to consider before selecting and implementing an EDC system. TRACK RECORD The first thing to consider is the track record of the eclinical system vendor: How long have the vendor and its EDC system been on the market? On how many studies has the system been implemented? Can the vendor produce testimonials and case studies from past customers to substantiate its marketing claims? Was the system utilized for any FDA submissions? Has the system and the team behind it worked on the therapeutic area of your clinical study? At Clinovo, our open source EDC system ClinCapture has been distributed for three years for phase I, II and IV studies, from 20 to 20,000 patients. Leading sponsor companies have secured FDA approval using ClinCapture as their preferred Electronic Data Capture (EDC) system. The Clinovo team has worked on a large variety of therapeutic areas and indications in the pharmaceutical industry, including Oncology, Opthalmology, Antibiotics, Parkinson s disease, Vaccines, Infectious diseases, Chronic Renal Failure, Rheumatology, Women s health, HIV/AIDS, Cardiovascular, Pain/Neurology, Diabetes, and more.

3 REGULATORY COMPLIANCE Make sure the EDC system you re evaluating is 21 CFR Part 11 Compliant. Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems. 1. EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed. 2. The EDC system provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database. 3. The software employs electronic signatures for any transaction into the system. 4. Vendors must also plan for disaster recovery and analyze and remedy potential risks. We find that some popular cost-efficient Electronic Data Capture (EDC) systems on the market are not 21 CFR Part 11 compliant, such as REDCap. These systems cannot be used for FDAregulated clinical studies, but only for research and investigational purposes. Clinovo s EDC system fully meets all 21 CFR Part 11 and FDA requirements. Clinovo's FDA compliance specialists follow a 14-step hybrid validation model based on risk analysis recommended by David Nettleton, one of the nation s foremost experts on Computer System Validation (CSV) for 21 CFR Part 11. DATA SECURITY Most EDC vendors offer a secure hosting, but we recommend to take a close look at where and how clinical data is being stored. Does the vendor provide disaster recovery? Is the data center SSAE-16 compliant? SSAE-16 (Statement on Standards for Attestation Engagements (SSAE) No. 16) defines the standards an auditor must employ in order to assess the contracted internal controls of a service organization, such as co-location service providers, including network and system management SOPs, security and business continuity. ClinCapture runs in a virtual environment that is completely isolated and abstracted from the underlying hardware. Customers study data is stored within its own private database instance. This environment has been previously validated, and the data is isolated and secure. For disaster recovery purpose, the clinical data replicates with Clinovo servers located in Clinovo s second data center in Reston, Virginia. PRICING MODEL The cost of implementing an EDC system can dramatically vary from a few thousand dollars to half a million dollars. Most EDC systems vendors charge customers a high upfront cost to cover heavy development and customization costs. The pricing model of most EDC systems is thus not transparent and varies depending on the project. Some systems will charge you depending on the number of users, which is well adapted to small clinical trials, but reportedly not scalable for longer and larger clinical trials.

4 We believe in a pricing model that adapts to your needs. ClinCapture operates on a pay-asyou-go tiered pricing model which adjusts depending on the features and services you require. ClinCapture is reportedly one of the most cost-effective Electronic Data Capture (EDC) system. One of our key clients claimed $320,000 savings by switching to ClinCapture, and 89% of our clients choose to repeat business with us. FEATURES Do you need a full-fledged EDC system or a more basic system? Some EDC features are definitely essential such as web-based data entry, edit-checks, source data verification, or role-based permissions, to name a few. However, you might want to consider if the EDC systems offers a Forms and Edit Checks Builder (to create CRFs and edit-checks yourself and save money and time), an easy to use event scheduler (to save time and automatically schedule follow-up events), randomization or medical coding functions. You should also look into the technology partners and supported integrations of the EDC system. You might need, for example, extended capabilities such as epro (Patient Reported Outcomes) or CTMS (Clinical Trial Management Systems). ClinCapture's development team is striving to provide customers with best-in-class features to meet their specific needs. We are introducing automations and improving workflows to save time and handle complex and demanding study protocols. ClinCapture is the first open source Electronic Data Capture (EDC) system to release advanced and integrated functions such as Randomization, Medical Coding, Dynamic Groups, Calendared Events. ClinCapture integrates with a suite of premium modules to complement your EDC needs. Our eclinical Suite includes an epro module, a CTMS system, a Patient Profiles system, and more. PLANNING AND FLEXIBILITY In order to fully benefit from EDC systems, it is critical for sponsors to plan ahead, and make sure goals are fully shared and aligned between their organization and the vendor. Most importantly, well reviewed plans must be executed prior to study build. Data entry screens, online edit check specifications, and the annotated case report form (acrf) must be implemented and tested before the study goes live. It is also important to plan ahead and ask vendors about the flexibility to proceed to mid-study changes. This can prevent from chaos further down the road. EDC systems make mid-study changes such as the addition of new fields in a Case Report Form (CRF) much smoother than do paper-based studies, will does the EDC system support CRF versioning to ease such a transition? Also, is it possible to scale up and down the study rapidly? Does the system give you the ability to modify edit-checks yourself in a matter of minutes? ClinCapture support CRF versioning to automatically update all CRFs in selected sites in just a few seconds. ClinCapture gives you the freedom to implement edit-checks yourself to save time and facilitate the roll-out of your study. ClinCapture features an integrated Rules Studio, a drag-and-drop graphical interface to build rules within ClinCapture without XML programming. The Rules Studio doesn't require any specific training or IT expertise. AUDIT

5 At the end of the selection process, some sponsors consider auditing the vendor. This step can lengthen the process, but avoids bad surprises down the road. As a sponsor, you are regulatory responsible that your clinical data is being stored and manipulated in compliant system. If you have any doubts in the ability of the eclinical system vendor to produce welldocumented SOPs, you need to audit it. ClinCapture passed every audit and auditors are pleased with the depth of our validation process and the amount of documentation we provide. It includes: product requirements, specifications, hazard analysis, unit test evidences, code reviews, release notes, build notes, installation protocol and qualification, operation qualification, performance qualification, and User Acceptance Testing (UAT). TRAINING AND SUPPORT Among common concerns, sponsors worry about the steep learning curve and heavy training needed to switch to an EDC system. The implementation of an EDC system drastically changes the structure and the processes within a sponsor organization. Some EDC vendors offer online, self-guided trainings to facilitate learning, while saving time and money in the process. Consider training and support as essential to the success of your project, and favor vendors that are putting an emphasis on training sessions for end users as well as on ensuring reactive support services. Clinovo offers personalized training sessions designed for the EDC experts directly in charge of your clinical trials. Moreover, Clinovo has used these personalized sessions to create an ondemand, fully online training program. The convenience of ClinCapture's On Demand Trainings will facilitate sites learning around the world. Online attendees will learn to enter subjects, schedule events, and manage queries efficiently. Lessons will split into different modules to focus your learning on your function: Clinical Data Manager, Medical Coder, Clinical Research Coordinator, Study Monitor, and Principal Investigator. We provide top-notch support for ClinCapture users through a dedicated online helpdesk platform. Clinovo contacts each individual who generates a ticket to address and understand the issue, analyze and develop a resolution plan, and provide a timeframe in which the ticket will be resolved. Tickets are investigated and resolved by Clinovo's technicians, or escalated to the ClinCapture development team if they require customization, programming, database changes, or other sophisticated issues. We can offer support to customers around-the-clock in multiple locations around the world, currently in English, French, or Russian. CONTACT INFORMATION Sophie McCallum Director of Operations Clinovo Phone: Clinovo

6 1208 E Arques Ave, suite 114 Sunnyvale, CA Phone: ABOUT CLINOVO Clinovo is a technology focused Contract Research Organization (CRO) headquartered in the Silicon Valley. Clinovo streamlines clinical trials for life science companies globally by developing validated, intuitive open source eclinical systems. Clients claim over 50% cost savings using Clinovo s open source Electronic Data Capture (EDC) system ClinCapture, and CDISC Express, the first open source CDISC conversion tool. Services also include Clinical Data Services, Staffing Solutions, and TechTrainings.

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