phase iib-iii clinical trial Data Management

Quality Data. Optimized Technologies.

Without clean, reliable data, no trial can be successful. That’s why PharmaNet’s global data management professionals work in concert with sponsor teams to develop an optimal strategy for managing your project’s data, with stringent quality-control measures at every step. PharmaNet’s robust, scalable and software-independent processes enable PharmaNet to efficiently capture, maintain, clean and deliver data for your project regardless of phase, therapeutic area, size, or data capture method.

PharmaNet’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 advise clients on the most appropriate method for data collection to best serve the needs of study sites and project team.

Efficient, software-independent processes allow us to flexibly deploy the clients’ data management software preference. We have extensive experience working in sponsor-hosted technologies and can follow PharmaNet’s or our client’s standard operating procedures. If a software preference is not identified, PharmaNet has expertise in a variety of software applications and can recommend one that that is right for your study. Our eight data management centers in the US, Europe, and India follow the same standard operating procedures to ensure global consistency, optimal workflow, data quality and efficient processes. PharmaNet’s standard processes are derived from the Good Clinical Data Management Processes (GCDMP) as defined by the Society of Clinical Data Management (SCDM). PharmaNet offers comprehensive data management services for studies utilizing EDC and/or traditional paper data capture methods including:

• Case Report Form (CRF)/eCRF
• Database design, implementation
• Data validation, review, and cleaning
• Medical coding
• 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 has established partnerships with leading EDC technology vendors enabling PharmaNet to provide full service design, build, and support activities in the following platforms:

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

These partner agreements ensure PharmaNet has the latest technology releases and best practices for efficiently designing and supporting studies in their platforms. In addition, PharmaNet 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 works for you.

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