Services
Prevail Expert Services Overview
Are you getting impatient for improved results? Why is all your hard work having less of an impact than you deserve?
Prevail Expertise at Work
Prevail’s suite of integrated clinical, logistics and financial oversight systems were fully deployed in only 17 days in a large Phase III study, with the first patient enrolled on day 18.
Prevail’s technology and domain experts are there to support your trial from start to finish, so you and your teams can focus on the protocol instead of the technology. Our customers are usually up and running on Prevail systems in just a few weeks from project start, regardless of complexity and any required integrations with your existing systems.
Prevail InfoWorks offers the full spectrum of end-to-end clinical services to support your clinical trial:
And since our cross-functional project teams are also expert users of our technologies, you can easily augment your current processes, people, and systems with Prevail’s best-of-breed software and services. As both an expert clinical software developer and highly experienced integrator, we take an agnostic approach and have successfully worked with every technology presented to us.
With 15+ years of proven success in hundreds of Phase I-IV trials across virtually all indications, Prevail can help improve your trial outcomes with:
- Procurement
- Site / vendor negotiation & contracting
- Clinical operations
- Project management
- Software and database development
- System integration (clinical as well as non-clinical systems)
- Clinical data management and data science
- Trial supply management
- Trial Master File management
- Pharmacovigilance
- Site monitoring
- Quality assurance & regulatory
- Clinical project accounting
- Site management
Ready to Improve Your Trial Outcomes?
Learn More About Each Service
Project Management
• Oversight and coordination of all functional groups and vendors
• Development of the project plans
• Study start-up strategy
• Recruitment strategy
• Management of study timelines, risks, and budget
• Advocate for your study
Information & Data Management
• EDC design, build and validation based on CDASH standards and CDISC TAUGs
• User support and training
• ePRO/eCOA content management
• Data management plans and edit checks
• Rolling data cleaning and reconciliation
• Clinical coding
• Clinical database lock and closeout
• Programming of SDTM, ADaM, and TLFs
• Setup data integrations, visualizations and analytics
Site Management
• Site identification
• Site qualification
• Site initiation
• Oversee local/central IRB submissions
• Investigator site folder preparation
TMF Management
• End to end trial master file management
• Prepare trial master file plan
• Setup and configure eTMF using DIA reference model
• Document collection, reconciliation and maintenance
• TMF status reporting
• Final TMF delivery
Contracting & Project Accounting
• Develop and negotiate contracts for investigator sites and suppliers
• Develop and negotiate investigator site budgets
• Validate and process payments to investigator sites and suppliers based on customer's preferred method
• Prevail Grant Navigator™️ automates invoice reconciliation process for greater accuracy
Clinical Monitoring
• Clinical monitoring plan
• Site visits and monitoring reports
• Remote and risk-based monitoring
• Site-based and data risk identification and mitigation
• Site support
Pharmacovigilance
• Prepare safety management plan
• Configure safety database, forms and reports
• Safety Specialist for:
- Case creation, Narrative writing, Coding, Query management, Quality control
• Trend and signal analysis
• Expedited safety reporting
• Periodic safety reporting support
Medical Monitoring
• Oversee safety and protection of research subjects
• Provide 24/7 medical, scientific and safety support to investigator sites
• Assist in accurately determining AE causality
• Review narratives and coding
• DSMB support
Clinical Supplies Management
• Create supplies management plan
• IWRS/RTSM: create specifications, build and validate
• Perform IP releases
• Manage initial and resupply orders, including setup of automated ordering
• Coordinate integration and management of packaging and labeling vendors, depots and shippers
• IP reconciliation
• Support safety unblinding