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Sponsor due diligence

Qualification readiness

Evaluate operating maturity before sharing sensitive program details. Materials are provided according to the sponsor's qualification process and may require an NDA.

Sample sponsor oversight artifacts

Redacted examples available during qualification

Examples demonstrate operating structure without publishing controlled procedures or confidential program details.

Governance plan

Roles, cadence, decision rights, and oversight interfaces.

Request sample under NDA

Medical escalation workflow

Question categories, review roles, response expectations, and follow-up.

Request sample under NDA

Risk register

Material risk, controls, owners, triggers, and current status.

Request sample under NDA

Vendor oversight dashboard

Performance signals, thresholds, decisions, and trends.

Request sample under NDA

CAPA tracker

Issue, root cause, action, owner, due date, and effectiveness review.

Request sample under NDA

Inspection readiness checklist

Oversight, records, issue management, and interview readiness.

Request sample under NDA

TMF health review summary

Expected records, observed gaps, risk, ownership, and remediation.

Request sample under NDA

Medical review tracker

Review question, information, outcome, communication, and closure.

Request sample under NDA

Decision log

Decision, rationale, accountable owner, date, and follow-up.

Request sample under NDA

Sponsor oversight report

Concise program status, exceptions, decisions, and actions.

Request sample under NDA
Category
Corporate documentation
Legal entity details, tax documentation, contracting inputs, and NDA process, as applicable.
Quality documentation
QMS overview, controlled-document catalog summary, training approach, and issue-management framework.
Oversight tools
Redacted governance plan, escalation model, risk register, decision log, and status-report examples.
Medical oversight
Medical review workflow, escalation pathway, interface model, and query-review approach.
Continuity
Coverage roles, handoff approach, access controls, and open-action transition model.
Personnel qualifications
Relevant CVs, credentials, role descriptions, and experience alignment for the proposed scope.

What happens next

  1. Provide a project-level description without PHI.
  2. Confirm requested scope, timing, and qualification requirements.
  3. Execute an NDA when needed before controlled details are exchanged.
  4. Review fit, interfaces, engagement model, and contracting path.

Request the package

Email the intake channel with your organization type, requested support area, study stage, target timing, and whether an NDA is required.

Email a qualification request View intake guidance
Data handling before qualification

Keep the first inquiry project-level

Public email intake is not the place for PHI, patient identifiers, source documents, full protocols, vendor bid details, or confidential trial strategy. Share only the organization type, general program stage, high-level need, target timing, geography, and whether an NDA or CDA is required.

Sensitive materials, controlled examples, personnel records, and QMS details should be exchanged only after the confidentiality path and transfer method are agreed.

Review privacy notice