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Services
Buy the people, buy the outcome, or buy both. Each pillar can be staffed as individual specialists, delivered as a project under a statement of work, or run as a functional service we own end to end.
The problem
A typical mid-size sponsor runs one agency for clinical staff, another for regulatory writers, a consultancy for validation and a systems integrator for the eQMS. Four contracts, four onboarding processes, four sets of quality expectations, and no single person accountable when a submission slips.
The cost is rarely in the rates. It is in the handoffs: the validation evidence that does not match the requirement it was written against, the regulatory writer who was never told what the quality team found, the second audit that repeats the first.
Our five pillars exist under one contract for that reason. The people writing your protocols and the people validating your systems answer to the same delivery lead.
Tell us the problem. A specialist replies, not a form robot.
What we do
Each is a full practice, not a line item. Follow any of them for the detail.
Clinical operations, trial management and monitoring, data management, biostatistics and pharmacovigilance, from first protocol to final report.
Submission strategy and authoring for the US, Europe and emerging markets, plus structured EU MDR and IVDR gap assessments.
Risk-based quality systems, audit programmes, computerised system validation and commissioning and qualification.
Validated application development, LIMS and eQMS implementation, and long-term support for regulated systems.
Medical writing, publishing support, drug information and market intelligence, delivered by domain specialists.
5
Pillars under one contract
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Questions
Yes, and most clients start that way. The pillars share a delivery model and a quality standard, but they are contracted separately. Nothing obliges you to consolidate.
Both. Submissions, validations and system implementations usually work better as an SOW with defined deliverables and fixed commercials. Ongoing operational support is usually time and materials. We will tell you which fits.
You do. Everything we produce under a services engagement, including validation evidence, protocols and submission documents, is your property and is handed over in a form your own team can maintain.
Separate teams, separate systems access and contractual walls. Our people are used to working under several sponsor quality systems at once; it is normal in this sector and we structure for it from the start.
It usually does. We price change explicitly rather than absorbing it silently and recovering it later, and we flag scope drift the week we see it rather than at invoice.
Related
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