Data Management

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, cost-effective solutions. Our multidisciplinary team of industry experts offer consulting along with standalone and full- service integrated solutions focused on project success and in line with your study goals.

Our approach starts with the end in mind, tracking backward along the regulatory pathway to ensure the data is reported, displayed, captured and fully compliant with global data and reporting requirements.  Effective communication and accountability ensure your projects stay on track, on time, and within budget.

Areas of expertise

• Portfolio management
• Biostatistics & programming
• Data operations
• Standards
• Clinical systems management

Our propriety technology and innovative delivery platforms automate tasks that have traditionally involved manually writing and validating programs. These comprehensive and flexible systems replace outdated, manually programmed processes with automated, reusable programs for data extraction, data transformation, statistical reporting and electronic publishing, resulting in significant process savings, streamlined documentation, and improved quality.

Electronic data capture (EDC) database build

We get our electronic data capture (EDC) build is completed quickly and effectively, supporting the study team to meet early 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, supported with:

• 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™
• InForm™
• 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.

Applied innovation

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.