Life Sciences

Clinical operations, eTMF QC, pharmacovigilance, Medical Information, and data review - stabilized with staffing or outcome SLAs, QA, and audit-ready evidence.

Problems We Solve Capabilities Start an RFP

Typical Pain Points

eTMF completeness and accuracy drift vs. DIA model; inspection risk
Site document backlogs; query aging; protocol deviation follow-ups
Safety case triage/processing surges; narrative quality variance
MedInfo response consistency; content version drift across regions
Data review listings exceptions; DPP & change control gaps
Audit trail and evidence scattered across systems

Roles We Staff

eTMF QC associates & leads (DIA model alignment)
Site startup & maintenance (SSU/SMU) coordinators
Safety case processing (ICSR) and triage (PV) specialists
Medical Information agents & quality reviewers
Clinical data reviewers; query management; reconciliation
QA auditors, trainers, WFM/analysts, knowledge authors

Staffing Managed Services

Outcomes & Examples

eTMF completeness 98% with accuracy AQL targets per zone/artifact
Query aging p90 ; protocol deviation follow-ups within SLA
PV case timeliness & quality ; narrative defects
MedInfo content adherence ; version and region controls aligned
DPP adherence; change control & definitions embedded in dashboards
Audit-ready evidence tiles and inspection packs

Case Studies Compare Models

Controls & Compliance

DIA Reference Model alignment; SOP/policy version control
AQL sampling plans; dual-review where risk justifies cost
21 CFR Part 11/Annex 11 considerations; training attestations
Inspection readiness: evidence tiles, audit trails, change logs

Trust Center Incident Response Sub-Processors

Tooling Ecosystem

eTMF/CTMS: Veeva Vault eTMF/CTMS, Medidata, Oracle Siebel CTMS
PV: Argus Safety, ARISg, Veeva Safety, case intake portals
EDC/Data: Medidata Rave, Oracle InForm, REDCap; listings tools
Knowledge/Docs: Veeva PromoMats, SharePoint/Confluence
BI/Ticketing: Power BI/Tableau/Looker; ServiceNow/Jira

KPIs We Track

eTMF completeness/accuracy, aging by artifact
Query aging (p50/p90), reconciliation defects
PV case cycle-time & quality; narrative defect rate
MedInfo first-contact resolution & content adherence
Definition adherence; audit ask turnaround

Model

Staffing

eTMF QC, site support, safety case triage, MedInfo, data review with QA sampling.

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Model

Managed Services

Outcome SLAs (completeness, accuracy, timeliness) with dashboards and evidence.

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Model

Consulting

Diagnostics to design DIA-aligned QC plans, PV timeliness gates, and inspection packs.

Diagnostics

Inspection-ready, every day.

Well propose staffing or outcome SLAs for eTMF QC, site support, PV, MedInfo, and data review.

Start an RFP Talk to Life Sciences Lead