TecronixTecronix

Pharma & Life Sciences

PV, clinical, regulatory, labeling, and RIM support with staffing or outcome SLAs. We bring SOPs, QA, and dashboards tuned to regulatory timeliness.

Problems We SolveCapabilitiesStart an RFP
Typical Pain Points
  • PV/ICSR surges (literature, spontaneous, solicited) with case aging and compliance risk
  • Clinical ops document control and TMF completeness gaps (eTMF QC findings)
  • Submission assembly bottlenecks (Module 1/2/3) and publishing timelines slip
  • Labeling change control complexity across markets; artwork/versioning errors
  • RIM/IDMP data quality issues; master data stewardship and lineage gaps
  • Medical information response backlog and knowledge base drift
Roles We Staff
  • Pharmacovigilance Case Processors, Triage/QC, Literature Reviewers
  • Clinical Operations Assistants, eTMF Specialists, Document Controllers
  • Regulatory Ops Associates, Submissions Publishers, Labeling Coordinators
  • RIM/IDMP Data Stewards, Master Data Analysts, CMC Admin Support
  • Medical Information Specialists, MSL Coordination, Inquiry Response
  • Quality/CSV Assistants: SOP control, training records, deviation/CAPA admin
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Outcomes & Examples

  • PV hub: compliant ICSR processing with aging controls and calibrated QC sampling
  • eTMF QC: completeness with checklist gates and last-mile document hunts
  • Submission desk: assembly/publishing turn time ; tracked defects with AQL classes
  • Labeling change control: artwork proofing workflow, country packs, version audit
  • RIM data quality: controlled attributes, lineage evidence, and reconciliation rhythm
  • Med info response: standard letters library, review workflow, and SLA adherence
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Controls & Compliance

  • GxP-aware processes; role-based access with JML and periodic reviews
  • PV timeliness (ICSR/PSUR/PADER) and QC sampling with calibrated defect classes
  • SOP/version control with change logs; training records tied to effective dates
  • Audit/inspection readiness: evidence tiles linking artifacts to outcomes
  • Privacy & data processing aligned to DPA; validated systems and CSV notes
Trust CenterIncident ResponseSub-Processors

Tooling Ecosystem

  • PV/Case Mgmt: Argus, ArisG, SafetyWorks; Literature: Embase, PubMed tools
  • eTMF/CTMS: Veeva Vault, Medidata, Oracle; Study tools & portals
  • RIM/IDMP: Veeva RIM, Ennov, Amplexor; Submissions: eCTD tools (Lorenz, eCTDmanager)
  • Labeling/artwork: Esko, GLAMS, Veeva; Change control via QMS
  • QMS/CSV: TrackWise, MasterControl, Veeva QMS; Training: LMS integrations

KPIs We Track

  • ICSR cycle time & aging, QC hit rate, regulatory timeliness
  • eTMF completeness, document QC defects, inspection findings
  • Submission assembly/publishing TAT, defect density by module
  • Label change lead time, artwork errors, country pack readiness
  • RIM attribute completeness, reconciliation exceptions
  • Med info response SLA, standard letter coverage, escalations
Model
Staffing

PV, clinical, and reg ops capacity with calibrated QA sampling.

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Model
Managed Services

Outcome SLAs (timeliness, completeness, quality) with evidence dashboards.

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Model
Consulting

Diagnostics to design PV hubs, eTMF QC programs, and RIM stewardship.

Diagnostics

Hit timeliness. Reduce findings.

Well propose staffing or outcome SLAs with PV/regulatory QA and inspection readiness.

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