Pharmaceuticals, Biotechnology & Medical Device Intelligence / Methods
Evidence-based decision support

From a claim to a defensible decision record

What is the authoritative product, trial and regulatory-record status?

Review a full dossier

Seven controlled research steps

  1. Agree the single decision, client inputs, deadline, conflict and legal boundaries

    Each material source and omission is dated, attributed and treated according to its evidential limits.

  2. Match identity, aliases, product identifiers or assets across records

    Each material source and omission is dated, attributed and treated according to its evidential limits.

  3. Log originals, timestamps, dates of effect, access permissions and coverage

    Reconcile product identifiers, sponsor identity, clinical registry and regulator notices.

  4. Create a claim-to-evidence matrix with independent contrary-source search

    Reconcile product identifiers, sponsor identity, clinical registry and regulator notices.

  5. Resolve chronology, entity relationships and alternative explanations

    Each material source and omission is dated, attributed and treated according to its evidential limits.

  6. Review reliance categories and missing records; apply human quality assurance

    Each material source and omission is dated, attributed and treated according to its evidential limits.

  7. Deliver a finite written record with a question pack for the professional decision owner

    Each material source and omission is dated, attributed and treated according to its evidential limits.

Sector-specific risk checks

  • trial not approval
  • device name mismatch
  • recall absent due to search limitation
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