Biostatistics
Protocols, SAPs, analyses, interpretation and methodology.
FLEXIBLE DELIVERY
FSP & Dedicated Biometrics Teams
Add stable, qualified biometrics capacity through controlled integration — with direct communication, role clarity, governance and delivery accountability.
FUNCTIONS
Functions We Can Support
Statistical Programming
SAS/R, CDISC datasets, TFLs, validation and submissions.
Clinical Data Management
Start-up, conduct, cleaning, reconciliation and lock.
Medical Writing
Clinical/regulatory writing integrated with data functions.
Quality / Project Support
Defined oversight, coordination and quality roles where required.
Project Management
Coordination, timelines, issue tracking and cross-functional delivery oversight.
MODEL
Controlled Integration, Not Anonymous Staff Augmentation
Role Matching
Profiles selected for function, seniority, therapeutic context, systems and expected workload.
Onboarding & Training
Client SOPs, systems, study context, access requirements and role expectations documented before productive work.
Governance & Oversight
Reporting line, workload visibility, review cadence and performance expectations agreed with the client.
Continuity & Back-Up
Knowledge-transfer and back-up expectations defined for recurring or critical workstreams.
Escalation & Replacement
Clear escalation routes and a controlled replacement process if role or workload needs change.
Confidentiality & Access
Access is limited to the assigned role and client environment, with study-specific confidentiality boundaries respected.
ONBOARDING
Typical Start-Up
01
Need Definition
02
Profile Selection
03
Client Interview
04
Onboarding
05
Governance
06
Ongoing Delivery