|Our customers receive frequent and clear communication, a mutual understanding of timelines and costs, critical thinking, seamless services, transparent processes, and fast, flawless execution resulting in quality deliverables. All are necessary, in real time, for informed decision-making. INC Research Data Services include:
- Project management
- CRF/eCRF design
- Database design & build
- Data entry & validation
- DCF/query management
- External clinical trial data management (labs, device data, images)
- AE/Con Med/disease coding
- SAE reconciliation
- Online quality & metric reporting
- Statistical analysis plans & reports (Biostatistics)
- Validation programming
- DSMB production & management
- Integrated safety/efficacy summaries (ISS & ISE)
- Preparation of statistical components to NDA
- Medical writing - final study report
Exceptional data management is the heart of the ProgramAccelerate® portion of our Trusted Process. Using the power of the latest technologies and the expertise honed from years of clinical data experience, the database is ready, accurately populated, and locked in an expeditious manner—with verification and validation procedures that ensure quality control every step of the way. This processing is done in synchronization with the clinical team, utilizing the information provided from the trial to ensure efficient processes are employed, regardless of capture method, from the first patient in through to database lock. INC Research is experienced in delivering data studies in EDC, paper and fax modalities globally.
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Electronic Data Capture (EDC)
INC Research has the ability to work with a variety of Electronic Data Capture (EDC) tools and make them work effectively to provide customers the solution that best suits their project needs. We utilize three leading EDC platforms - Medidata Rave, Oracle Clinical On-Site and Phase Forward’s Inform products. Our ability to design, build and deliver high quality databases in all three platforms enables our team to deliver the right EDC solution for every trial.
To compete in today's changing global drug and device development environment, companies must collect and distribute data faster than ever before. INC Research helps its customers harness the power of EDC. Our foundational EDC functionality is based on the leading technology platforms to provide our customers with a broad spectrum of EDC options that suit their needs. We have the ability to manage EDC studies to help our customers take advantage of the efficiencies available through this technology - improved access to data, less paper, reduced cycle time, increased productivity and improved relationships with customers, vendors and other partners.
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The biostatistics team at INC Research has a depth of experience with the FDA and the EMEA, which means our teams provide customers with solid guidance on building a statistical plan that will meet regulatory and safety requirements. We provide support for independent Drug Safety Monitoring Boards (DSMB) and a full range of related services. Our biostatisticians are heavily involved in the PlanActivation® stage of our Trusted Process, so protocol and project development are grounded in sound, advanced statistical methodology. As part of a project team, our biostatisticians can provide a critical eye for any data or data handling issues that need to be resolved for analysis. Our experts can lend key data oversight throughout a trial.
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SDTM the INC Research way
As an early adopter of CDISC standards and a Platinum Member, our SDTM experts have on average five years’ SDTM experience. When combined with our broad therapeutic expertise, CDISC Initiative (ensuring up-to-date knowledge) and ability to leverage the skills of the broader INC Research team, we’re able to deliver high-quality SDTM-related services or support sponsor-specific requirements confidently. In fact, we’ve mapped more than 500 studies to SDTM standards, 600 to ADaM standards and 160 with define.xml to both – deliverables all validated using OpenCDISC Validator.
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Interactive Voice or Web Response Systems
INC Research has the ability to develop a variety of functions in IVRS/IWRS through our business partners and make them work effectively to provide customers with the solution that best suits their project needs. With our study-specific development approach, our focus is on having an experienced IVRS/IWRS team in place, helping to provide the IVRS/IWRS solution that makes sense for our customers, and providing effective Randomization and Drug Tracking. Our IVRS/IWRS development, functionality and support provide our customers with a broad range of options that can be tailored to their specific studies. We have the ability to manage IVRS/IWRS studies to help our customers take advantage of the efficiencies available through this technology.
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For more information on INC Research’s Data Services capabilities, click here.