You set the priorities
You decide what needs doing and when, and you tell the team lead. From there the day-to-day direction of the work sits with us — task allocation, prioritisation within the agreed scope, technical review and sign-off.
Dedicated biometrics capacity that works as part of your team. Your processes, your systems, your priorities with the hiring, retention and management handled by us.
FSP sits between hiring and outsourcing, and what separates a good arrangement from a poor one is where the management line falls. Ours is drawn so you direct the work without carrying the people: recruitment, retention, training and backfill stay with us.
You decide what needs doing and when, and you tell the team lead. From there the day-to-day direction of the work sits with us — task allocation, prioritisation within the agreed scope, technical review and sign-off.
A named Metronomia team lead owns resourcing, performance management, training and cover. You get status, escalation and forecasting through one person instead of line-managing individual contractors.
Because we employ, manage and appraise the team, the engagement stays a service contract rather than a set of individual placements you are responsible for.
Two things separate this from contract staffing: the people you get, and who carries responsibility for them.
We are the biostatisticians, programmers, data managers and medical writers doing the work. Biometrics is our focus, so each role is filled by someone with the expertise and experience the study requires.
The team lead manages utilisation, quality and cover throughout the engagement. If someone leaves, we handle the replacement and documented handover, typically within 4–6 weeks for a senior role.
You see the CV and can speak with each proposed team member before onboarding. No substitutions are made without your agreement, and backup is planned for key roles.
We build teams across our delivery centres in the US, UK, Germany and South Africa, giving you access to the right expertise and time-zone coverage without adding more vendors to manage.
Experienced clinical data professionals who work to your SOPs and report into your team, chosen for your study.
Study design and sample size, SAP authoring, estimand strategy, interim and ISS/ISE analysis.
SDTM and ADaM, TFLs, define.xml and reviewer guides, in SAS and R.
CRF design, edit checks, data review and query management through to database lock.
eCRF and edit-check build, integrations and validation on Medidata Rave, Viedoc and Clincase.
Protocols, CSRs, narratives, IBs, briefing books and EU CTR lay summaries to ICH E3.
Standards governance, mapping, controlled terminology and submission-package review.
The right fit depends on the capability you already have in-house and how steady your study volume is. Most sponsors change models as their programme grows, and we build for that from the start.
You have statistics in-house and need programming, or the reverse. A team in one discipline, full-time or fractional, reporting through one lead.
Data management, statistics, programming and writing under a single lead, working to one set of standards so data moves between them without re-work.
An FSP team for steady-state delivery, with scoped project work alongside it for submissions, integrated analyses or a rescue. Budgets stay separate; the lead spans both.
We define the roles against your protocol, source and assess candidates, and present a shortlist with full profiles. You approve each appointment before onboarding begins.
Disciplines, seniority, FTE level, languages and the reporting line into your organisation.
We put forward named people against that profile, with full CVs and a technical screening call. You approve every person before onboarding begins.
Your SOPs, your systems, your therapeutic area. Two to four weeks for a single role; four to eight for a full team, with bridging cover if a role is urgent.
The team lead runs delivery, reports on utilisation and quality, and flexes the team as your pipeline moves. Backfill and cover stay our responsibility.
Most engagements draw on more than one location, which gives you extended time-zone coverage and continuity when a study runs around the clock.