Industries

Pharma & Life Sciences

For the Head of Portfolio, the Chief Medical Officer, and the Head of Regulatory Affairs in pharmaceutical organisations where every go/no-go decision — at a Stage Gate, a DSMB, or a submission-readiness review — will eventually be inspected.

21 CFR 11

FDA requires full decision audit trails

$2.6B

Average cost to bring a drug to market

45%

Of advancement decisions lack formal governance

The Challenge

Decisions that cannot be reconstructed

Drug development decisions—which compounds to advance, which trials to prioritize, which markets to enter—are governed by complex, evolving criteria.

When regulators ask "why was this decision made?", the answer is often scattered across emails, meeting notes, and the memories of people who may no longer be with the organization.

Common failure points

  • Go/no-go criteria that exist only in experts' heads
  • Regulatory submissions that can't trace back to decision rationale
  • Portfolio decisions made inconsistently across therapeutic areas
  • Knowledge loss when key scientists retire or leave

"The regulatory question is never what you decided — it's why you decided it, and whether you would decide the same way again."

The Solution

How Juris helps pharma organizations

Portfolio advancement you can defend

Every stage-gate decision — advance, hold, terminate — compiled from the governance framework, evidenced by the data that triggered it, and traceable at inspection.

Clinical-trial governance at the DSMB moment

Efficacy thresholds, futility boundaries, safety-stopping rules — compiled from the protocol and enforced on the interim data. The DSMB minutes write themselves.

Submission readiness, certified before you file

Juris compiles the FDA guidance and your internal readiness criteria into an executable checklist and tells you, with evidence, which sections are ready and which are not.

From implicit expertise to certified logic

Juris doesn't replace scientific judgment—it captures and certifies the logic that judgment produces, so every decision can be explained when scrutiny arrives.

Ready to certify your decision logic?

See how Juris helps pharma organizations preserve and defend their most critical decisions.

Request an Enterprise Demo