High quality data to enable stronger and more informed decision making
Fast delivery of high quality and meaningful data means that you can make well informed decisions earlier in the trial. This also ensures patient protection and reliable trial results.
Sponsors rely on us for flexibility, quality, and technical expertise in our customised solutions. We offer consulting, standalone, or full service integrated solutions focused on project success and in line with your study goals.
1,300+EDC studies completed
75%Reduction in resource costs
Electronic data capture (EDC) database build
We get our electronic data capture (EDC) build completed quickly and effectively. This should help you to stay on your timelines and meet critical milestones.
The full process from final protocol to a live EDC will take place within eight weeks. Associated validation checks are completed to ensure the highest quality deliverables and is support by:
- Rigorous control and deployment of standards
- Streamlined review and approval process
- Interactive online review meetings and UAT
We are an industry leader in the management of EDC studies and have full EDC build capabilities in all key systems including:
- Veeva Vault CDMS™
- Medidata for Rave™
- DataTrak for UX EDC™
Day database lock target of 21 days
Early planning with cross functional teams enables us to achieve database lock within a 21 day timeframe. We provide ongoing data review, along with efficient reconciliation of external data.
Identifying site trends and implementing risk mitigation strategies enables us to keep processes on track. Study unlocks are kept to a minimum with metrics indicating under 3% after database lock.
Integrating data for improved efficiency
We are able to consolidate our data with external vendor data including; Laboratories, ECG, Safety, ePRO, and IxRS. Integrate of data removes the need for multiple platforms.
Cost competitive pricing
Leveraging our global capabilities, cross functional collaboration and creating standard data structures, we can offer you maximum cost efficiency and shorter development timelines.
ICONIK, our proprietary technology platform, collects real-time data during the trial process enabling better decision making and the successful implementation of clinical trial strategies.
This also enables us to review your data holistically, and identify site trends or potential risks earlier in the trial. We combine data management expertise, best practice processes with ICONIK to drive success in studies.
Experience you can trust
One of the key drivers of success in your study is to have an experienced Data Management team. We are Platinum CDISC members, and have field leading expertise in SDTM and legacy data conversion. Over 120 members of our staff are trained in SDTM implementation.