Acquirers & Licensing Partners: the data room is not the trial.

Acquirers and licensing partners — the data room is not the trial. Clinical Execution Diligence
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Acquirers & Licensing Partners

The data room is not the trial.

Clinical Execution Diligence — commissioned by those investing in, acquiring, or licensing the asset.

The data room shows the program, the results and the plan. It rarely shows how reliably the trials are being executed across the sponsor, its contract research organizations, its vendors and its sites.

For: Strategic acquirers · Licensing partners · Special purpose acquisition companies (SPACs)

The questions we answer

  • Does the execution system support the value being underwritten?
  • What material compliance exposures or execution risks are present?
  • Is what the data room shows consistent with how the trials are actually being run?
  • Decision supported: Acquisition, licensing, or partnership decisions.

How it works

  1. Scoping: We review the trial or program and agree scope, access and timeline. Fixed fee agreed at scoping.
  2. Authorization and access: The asset owner authorizes access under your confidentiality agreement. We can be engaged through your deal counsel.
  3. Assessment: Document and systems review, interviews, and site checks where access allows.
  4. Findings to the deal team: Interim read-outs on anything material, then a written report. Findings and materiality only, to the engaging party.

What we examine

Sponsor oversight · The operational contract research organization · Specialty vendors · Sites · Safety · Data and systems · Deviations · Inspection history · Governance, escalation and corrective actions · The interfaces between all of them

Independent by design

  • We do not run trials.
  • Independent of the sponsor and the transaction.
  • We never act on both sides of the same asset.
  • Confidentiality and information barriers agreed in advance where a company is publicly listed.
  • Findings, not forecasts.

Depth: Executive View or Full Assessment · Scope: Single Trial, Program or Enterprise

Discuss Clinical Execution Diligence · Confidential. Secure. Trusted.

Execution does not fail within functions. It fails at the interfaces between them.™