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Clinical & CRO Services
Trials get more complex every year. We absorb that complexity rather than pass it back, holding the sites, vendors, data and submissions of your study under one accountable team.
The problem
A protocol amendment reaches the sites a fortnight after the monitors have been briefed. A vendor changes a data specification without telling the statistician. Enrolment stalls at three sites and nobody escalates until the monthly report. None of these are scientific failures, and all of them cost months.
The usual answer is more oversight: another tracker, another status call, another functional lead. That adds cost without adding grip, because the fragmentation is structural. Six vendors reporting separately cannot self-coordinate.
We take the coordination problem as ours. One delivery lead owns the moving pieces, and the functions that have to talk to each other sit inside the same team rather than across a contract boundary.
Tell us the problem. A specialist replies, not a form robot.
What we do
Take the full package or reinforce the single function where the study needs it.
Feasibility, site selection, start-up, enrolment oversight and vendor management, held to metrics agreed up front.
Planning, operations, monitoring and project management as one package, or plugged into the single function you need.
Risk-based monitoring with a central function watching the data continuously between site visits.
CRF design, database build, edit checks, coding, reconciliation and lock on established EDC platforms.
Project managers with clinical research backgrounds and formal PM training.
Study design input, analysis plans, randomisation, interim analyses and CDISC-compliant deliverables.
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Therapeutic areas run under one operating model
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Questions
Either. Some sponsors hand us the whole study; more often we take one or two functions, most commonly monitoring and data management, and integrate with the sponsor team and existing vendors.
Cardiovascular, metabolic, CNS, renal, infectious disease, haematology and oncology, with one integrated operating model rather than separate silos per indication.
Yes, and rescue work is a real part of what we do. It starts with an honest assessment of where the study actually is, which is sometimes not where the last status report said.
Established platforms including Medidata Rave, plus partner technologies. We can work in your instance or provide one.
Functional support is usually time and materials against an agreed FTE profile. Defined deliverables such as a database build or a statistical analysis plan work better as a fixed-scope SOW.
Related
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