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Services
Five pillars, one accountable team.
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
Vendor sprawl is the quiet tax on every regulated programme.
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.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
Five pillars.
Each is a full practice, not a line item. Follow any of them for the detail.
Clinical & CRO Services
Clinical operations, trial management and monitoring, data management, biostatistics and pharmacovigilance, from first protocol to final report.
What that means for you
- One integrated operating model rather than siloed functional handoffs
- Capacity that scales from a single site to a multinational programme
- Inspection readiness maintained throughout, not assembled at the end
Regulatory & EU MDR
Submission strategy and authoring for the US, Europe and emerging markets, plus structured EU MDR and IVDR gap assessments.
What that means for you
- Strategy and authoring from the same team that defends the file
- Gap assessments that end in a costed plan, not a list
- Writers with genuine scientific and clinical backgrounds
Quality & Validation
Risk-based quality systems, audit programmes, computerised system validation and commissioning and qualification.
What that means for you
- Effort concentrated where patient impact and data criticality are highest
- Findings ranked by impact, each with a practical remediation path
- Documentation that survives contact with an inspector
IT Services
Validated application development, LIMS and eQMS implementation, and long-term support for regulated systems.
What that means for you
- Validation evidence and traceability treated as first-class requirements
- Built to be maintainable by your own team after handover
- Retainers that stop validated systems degrading quietly
KPO & Knowledge Services
Medical writing, publishing support, drug information and market intelligence, delivered by domain specialists.
What that means for you
- Every workstream staffed to match the judgement it requires
- Documented quality review before anything reaches you
- Scaled to your workload rather than a fixed retainer
5
Pillars under one contract
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Questions
Questions we get asked before the first call.
Can we use one pillar without the others?
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.
Do you deliver under a statement of work or time and materials?
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.
Who owns the deliverables?
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.
How do you handle confidentiality across competing clients?
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.
What happens if the scope changes mid-programme?
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
Where to go next.
Send us one requisition.
Judge us on the shortlist, not the sales deck.