phase iib-iii clinical trial Data Management

Quality Data. Optimized Technologies.

Without clean, reliable data, no trial can be successful. Look to PharmaNet/i3 for an innovative approach to clinical data management that's shaped by superior industry experience. This depth of experience enables us to precisely pair technology and proven processes with clinical studies -- from small Phase I/IIb clinical trials to large Phase III-IV multinational studies -- and to help streamline the route to more efficient and effective solutions. 

PharmaNet/i3’s study-specific approach to data management begins with a careful review of the study specifications, client preferences/history, data to be collected, and technologies available. We then provide guidance to clients on the most appropriate method for data collection to best serve the needs of study sites and project team.

Our robust, scalable and software-independent processes enable PharmaNet/i3 to efficiently capture, maintain, clean and deliver data for your project regardless of phase, therapeutic area, size, or data capture. We have extensive experience working in sponsor-hosted technologies and can follow PharmaNet/i3's or our client's standard operating procedures. If a software preference is not identified, PharmaNet/i3 has expertise in a variety of software applications and can recommend one that is right fr your study.

Our twenty-four data management centers spanning all time zones in the US, as well as multiple time zones in Europe, India, and China follow the same standard operating procedures to ensure global consistency, optimal workflow, data quality and efficient processes.  PharmaNet/i3’s standard processes are derived from the Good Clinical Data Management Processes (GCDMP) as defined by the Society of Clinical Data Management (SCDM). PharmaNet/i3 offers comprehensive data management services for studies utilizing EDC and/or traditional paper data capture methods including:

• Case Report Form (CRF)/eCRF design
• Database design, implementation
• Data validation, review, and cleaning
• Medical coding
• All data management processes are inspected by an independent management quality control team
• Comprehensive management of data from third-party electronic data vendors
• Data consolidation, migration, and conversion including CDISC SDTM Transformations
• Study rescue services
• Consultation and data management strategies, systems, procedures, and metrics
• Flexible staffing

PharmaNet/i3 has established partnerships with leading EDC technology vendors enabling PharmaNet/i3 to provide full service design, build, and support activities in the following platforms:

• Medidata Accredited Partner
• Oracle InForm Enterprise Adoption Partner
• Oracle Business Process Outsourcing (BPO) Partner

These partner agreements ensure PharmaNet/i3 has the latest technology releases and best practices for efficiently designing and supporting studies in their platforms. In addition, PharmaNet/i3 also maintains active relationships with multiple electronic data vendors including ePRO and other mid-tier EDC vendors. These relationships ensure we can efficiently integrate and work with these systems.

For high quality data, the software and SOPs of your choice, and a global infrastructure, PharmaNet/i3 works for you.

PharmaNet/i3 is an active participant in the SCDM Certified Clinical Data Manager (CCDM) program and is recognized as a CCDM© Industry Partner.