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Service Package Offerings

Service Packages

Fixed-cost packages, clear deliverables

Compliance expertise that keeps budget in mind — each package is a focused, time-limited project with all-inclusive pricing and a defined outcome.

AI Training
Tier I
  • Kickoff Meeting1 hour — outline training needs.
  • Stakeholder Training1.5 hours with an AI expert + Q&A (recorded & transcribed). Unlimited attendees.
  • Presentation Slides1 customized slide deck.
  • Closeout Meeting1 meeting 2 weeks post training for Q&A.
AI Training
Tier II
  • Kickoff Meeting1 hour — outline training needs.
  • Stakeholder Training1.5 hours (Basics)
    + 1 hour Advanced AI Training (e.g., IRB Chairs or Compliance). Recorded & transcribed. Unlimited attendees.
  • Presentation Slides2 customized slide decks.
  • Checklists & Templates1 AI checklist tailored to your needs.
  • Closeout Meeting1 meeting 2 weeks post training for Q&A.
IACUC Startup Kit
 
  • Kickoff Meeting1 hour — outline plans for an IACUC at your organization.
  • Stakeholder Training2 training sessions for IACUC members and researchers.
  • Presentation Slides1 customized presentation.
  • Checklists & TemplatesCharter template, appointment-letter templates, reviewer checklist, 2 SOP templates & SOP development guideline.
  • Closeout Meeting1 meeting 2 weeks post training for Q&A.
Student Project
IRB Review
  • Kickoff Meeting1 hour — establish a submission process to HRP; set up “office hours” with HRP staff.
  • Stakeholder TrainingWebinar — IRB 101 for students (recorded for future use).
  • Presentation Slides1 customized presentation.
  • IRB DeterminationExempt reviews; completion of checklists; determination letter generated.
  • Program DurationExpected program duration: 5 months.
HRPP / IRB / IACUC
Compliance Assessment
  • Kickoff Meeting1 hour — outline current pain points or program gaps.
  • Document ReviewSOPs, checklists, templates & sample minutes; inspection records; review of 1–3 active projects (max 20 hours).
  • Closeout MeetingSummary report + stakeholder meeting to review observations and action items.
IRB Reliance
Checkup
  • KICKOFF MEETING1 hour — map your current reliance model, internal review scope & local ancillary-review triggers.
  • PROCESS REVIEW2 recent projects reviewed against local requirements to identify strengths and growth areas.
  • DOCUMENT REVIEWRelevant templates, checklists & SOPs, determined at kickoff.
  • PERSONNEL1 hour of Q&A with key staff. Organizations without templates will receive 1 policy template and 1 checklist template. Organizations with templates will receive feedback about their documents in the report.
  • TEMPLATES1 template policy & 1 template checklist; existing templates receive feedback in the engagement report.
  • CLOSEOUT MEETINGEngagement report with observations and action items.
SOP Essential
Compliance Review
  • KICKOFF MEETING1 hour — set the focus of the SOP evaluation (e.g., regulatory consistency, operational efficiency).
  • DOCUMENT REVIEWIRB SOPs against the Common Rule (45 CFR 46), FDA (21 CFR 50, 56) & AAHRPP standards; research application, staff screening & member initial-review checklists; chair meeting agenda.
  • DELIVERABLESWritten report with gap analysis, observations & action items; 2 study files checked for consistent SOP application; up to 5 template SOPs or checklists.
  • CLOSEOUT MEETING1-hour stakeholder meeting with HRPP/IRB leadership to review the final report.
Short Term Staffing
 
  • KICKOFF MEETING1 hour.
  • CONSULTANT PROFILESeasoned IRB professionals with extensive operations experience — focused on backlog or new incoming submissions.
  • RAMP-UPMinimal training required; work begins as soon as system access is established.
  • PERSONNEL10 hours per week for 8 weeks. $1,250/week = FTE at $65,000.
  • CLOSEOUT MEETINGEngagement wrap-up with HRP leadership.
COI
Conflict of Interest
  • KICKOFF MEETINGOverview of how your organization is keeping pace with federal expectations on conflict of interest & foreign influence (NIH, NSF, DOE, DOD & other sponsors); identify existing organizational conflicts.
  • DOCUMENT REVIEWIndependent assessment of policies on financial COI, conflict of commitment, foreign influence, international collaborations & outside activities; disclosure forms, sample management plans and reported industry & foreign affiliations.
  • DELIVERABLESWritten report with gap analysis, observations & action items.
  • TEMPLATES1 template policy & 1 template checklist; existing templates receive feedback.
  • CLOSEOUT MEETING1-hour stakeholder meeting with COI/HRPP/IRB leadership to review the final report.
Compliance Software
Operational Effectiveness
  • KICKOFF MEETING1 hour — overview of existing software & workflows; select 1–2 workflows for assessment (e.g., initial application, full board review).
  • DOCUMENT REVIEWLimited-scope review of related SOPs to confirm consistency with electronic submission workflows and forms.
  • ASSESSMENT3–5 recent submissions traced end to end:
    • Is the system used as intended?
    • Are there inefficiencies or bypassed steps?
    • Does it match the SOP?
    Plus 3 stakeholder interviews.
  • DELIVERABLESPolicy / system alignment matrix + written report on user adoption, information quality, system compliance & action items.
  • CLOSEOUT MEETING1-hour stakeholder meeting with HRPP/IRB leadership to review the final report.

Not sure which package fits? We’ll help you scope the right engagement.