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. 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.
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. invivodata supports all standard data formats, including: SAS, ASCII, and XML and provides archival services necessary to meet GCP requirements.
Epro ontime archive#
Each study's Data Management, Quality and Reporting Plan, completed during the Study Build phase, ensures that all necessary data plans are properly documented.ĭata Delivery and Archive Services: invivodata offers the flexibility to provide standard and custom data delivery packages to meet the needs of sponsors. A world-class global support team is assigned to support invivodata studies and is trained on each study prior to study launch.ĭata Administration and Reporting: invivodata provides concise data processing services designed to increase data quality and visibility for clinical study personnel.
Epro ontime professional#
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. Following established equipment management and logistics processes, invivodata has experienced less than 1% device loss across all trials. Equipment is shipped from local provider sites, eliminating customs and overseas shipping issues. These services apply proven expertise in worldwide distribution to deliver ePRO equipment for studies on-time, anywhere in the world. Provisioning and Logistics Services: invivodata provides provisioning and logistics services through a certified world-class service network. At the end of the defined training program, a certification process is administered, allowing sponsors to meet 21 CFR Part 11 requirements. invivodata also provides "train-the-trainer" services for CRAs, so that these study experts can train investigators as needed. invivodata always delivers custom training designed to meet pre-defined study needs.
Epro ontime software#
invivodata's training sessions provide a combination of classroom and hands-on exercises using the actual study software and devices. 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.ĮPRO Training Services: A key of any ePRO implementation is user training at all levels. System Configuration: System Configuration services configure the software using standard and proven modules. The flexible design process results in a tailored ePRO system to meet the specific requirements of your protocol. Their consultative review and analysis determines an optimal software design- incorporating best practices related to ePRO regulatory and behavioral science guidelines. Solution Development: The analysis performed by the invivodata Solution Development Specialists plays an important role in invivodata's ePRO implementations.
Project Managers manage and apply the right qualified resources at the right time to execute efficient ePRO clinical studies. Project Management: invivodata's Project Managers guide ePRO implementations with a proven methodology tailored specifically for rapid, effective, and simple ePRO execution.
invivodata's core ePRO services support all aspects of the study from start to finish. 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 delivers unequaled site satisfaction and fast, effective clinical studies through proactive ePRO services.
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