ePRO Services
invivodata delivers unequaled site satisfaction and fast, effective clinical studies through proactive ePRO services. invivodata combines scientific and regulatory expertise with over 20 years of ePRO experience into proven, professional, repeatable services to make our ePRO solutions easy-to-use and manage. invivodata's core ePRO services support all aspects of the study from start to finish.
Project Management: invivodata's Project Managers guide ePRO implementations with a proven methodology tailored specifically for rapid, effective, and simple ePRO execution. Project Managers manage and apply the right qualified resources at the right time to execute efficient ePRO clinical studies.
Solution Development: The analysis performed by the invivodata Solution Development Specialists plays an important role in invivodata's ePRO implementations. Their consultative review and analysis determines an optimal software design-- incorporating best practices related to ePRO regulatory and behavioral science guidelines. The flexible design process results in a tailored ePRO system to meet the specific requirements of your protocol.
System Configuration: System Configuration services configure the software using standard and proven modules. Trial-specific modifications can then be made quickly and efficiently to build a software solution specific to your protocol without having to develop trial-specific software from scratch each time.
ePRO Training Services: A key of any ePRO implementation is user training at all levels. invivodata's training sessions provide a combination of classroom and hands-on exercises using the actual study software and devices. invivodata always delivers custom training designed to meet pre-defined study needs. invivodata also provides "train-the-trainer" services for CRAs, so that these study experts can train investigators as needed. At the end of the defined training program, a certification process is administered, allowing sponsors to meet 21 CFR Part 11 requirements.
Provisioning and Logistics Services: invivodata provides provisioning and logistics services through a certified world-class service network. These services apply proven expertise in worldwide distribution to deliver ePRO equipment for studies on-time, anywhere in the world. Equipment is shipped from local provider sites, eliminating customs and overseas shipping issues. Following established equipment management and logistics processes, invivodata has experienced less than 1% device loss across all trials.
Study Support Services: invivodata provides global helpdesk services through certified, professional helpdesk experts, which results in a high-level of customer satisfaction for site personnel and study patients. A world-class global support team is assigned to support invivodata studies and is trained on each study prior to study launch.
Data Administration and Reporting: invivodata provides concise data processing services designed to increase data quality and visibility for clinical study personnel. Each study's Data Management, Quality and Reporting Plan, completed during the Study Build phase, ensures that all necessary data plans are properly documented.
Data Delivery and Archive Services: invivodata offers the flexibility to provide standard and custom data delivery packages to meet the needs of sponsors. invivodata supports all standard data formats, including: SAS, ASCII, and XML and provides archival services necessary to meet GCP requirements.
Regulatory Inspection Support: invivodata's Regulatory Inspection Support service provides sponsors and site personnel with the tools required to respond to inspectors' inquiries regarding ePRO data collected as part of NDA submissions. In fact, invivodata has participated in and supported our customers in several regulatory ePRO inspections, including FDA, EMA, BfArM, and PMDA, which have resulted in successful new drug approvals. Through our proven regulatory inspection support services, our ePRO inspection team becomes an extension of your company, allowing you to rapidly and accurately respond to issues raised by the inspector. (Download ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes white paper.)