IEGPIntegrated Evidence Generation Planning

The system of record for your evidence plan.

Keystone replaces gap spreadsheets and slideware with one traceable plan. Every evidence need is linked to the sources that raised it, the tactics that cover it, and the people who signed it off.

Human sign-off at every gate Full version history Works with or without AI models

One plan, shared across the asset team

  • Medical Affairs
  • HEOR
  • Real-World Evidence
  • Market Access
  • Clinical Development
  • Regulatory
  • Commercial
The problem

Spreadsheets can't tell you what's still unresolved.

Every asset team has to answer the same question: what do we need to know, what evidence exists, and which open questions matter most? Static gap trackers get it wrong in four predictable ways.

01

Opinions become gaps

A stakeholder comment goes straight onto the tracker as a validated gap, with no test of whether it's real.

Keystone: every comment starts as a candidate need.
02

A study existing means "closed"

A chart review with no comparator gets marked done, even though the HTA question was comparative.

Keystone: coverage is scored on ten dimensions.
03

One study, four copies

A registry covering sequencing, HCRU and quality of life gets pasted onto three rows that drift apart.

Keystone: one record, linked to every gap it covers.
04

Coverage confused with priority

A mostly covered HTA question can still be the most important open item. Trackers can't express that.

Keystone: priority is a separate, signed-off decision.
Workflow

From source documents to a signed-off plan.

Keystone drafts and computes. Your team reviews, decides and signs off. New sources flow back through the same four stages, so the plan stays current between planning cycles.

STAGE 1

Upload

Ingest advisory board notes, KOL interviews, HTA feedback, protocols and publications.

  • Extracts candidate needs
  • Maps existing tactics
STAGE 2

Gaps

Each gap gets a computed status: Open, Partially Addressed or Addressed. Reviewers validate every one.

  • Partial gaps must be split
  • Overrides need a reason
STAGE 3

Prioritize

Place open gaps on a configurable matrix and set High, Medium or Low.

  • Set by people, never the engine
  • Separate from coverage
STAGE 4

Tactics

Propose studies and dissemination tactics for high-priority gaps and lay them out on a timeline.

  • Interactive Gantt view
  • Save and export the final plan
Worked example

A partial answer stays partial.

Source · Advisory board

"We don't have enough evidence in elderly patients."

  1. Keystone records this as a candidate need and links it to a named gap.
  2. It maps the tactic that already exists: a retrospective real-world study in patients aged 65 and over.
  3. Coverage is scored by dimension. The comparator is missing, so the gap is Partially Addressed.
  4. The reviewer splits it. The original moves to version history and a new Open gap is created for the comparator question.
  5. HEOR sets that gap to High ahead of the HTA submission, with a recorded reason.
Coverage assessment · G-014
Retrospective RWE, age ≥65, no comparator
Partial
DimensionCovered
PopulationYes
InterventionYes
ComparatorNo
OutcomesYes
Decision utilityNo
OverallPartial
OpenG-024 · Comparative outcomes vs regional standard of care
HighSet by J. Ortiz, HEOR · Reason: HTA decision date, comparator not covered
Governance

Built for teams that have to defend their decisions.

The engine proposes. People decide. Every decision is recorded with who made it, their function and why.

Sign-off at every gate

Nothing is closed or prioritized automatically. A named reviewer validates each gap and records their function.

Complete version history

Split or rewritten gaps are retired, never overwritten. Every child traces back to its parent.

Linked, not copied

Each need is stored once. One registry can cover several gaps without duplicate rows going out of sync.

Ten-dimension coverage

Population, comparator, outcomes, decision utility and more, each assessed, with an overall degree you can audit.

Conflicts are flagged

When new evidence disagrees with a reviewer's override, Keystone marks it stale instead of silently replacing it.

Evaluated against gold

Each pipeline stage is measured against reference cases, with run traces you can inspect.

Platform

Modular, observable, model-agnostic.

Each stage, from upload to timeline, is an independent module with its own contract, monitoring and evaluation. Swap models without rebuilding the plan.

11

Pipeline stages

Each one versioned, traced and runnable on its own or as a chain.

5

Model providers

Claude, GPT, Gemini, Grok and OpenRouter, routed per stage.

0

Models required

Without a connected model, deterministic rules run the whole pipeline.

1

Traceable chain

Source → need → gap → tactic → coverage → priority → roadmap.

Request a demo

See your evidence plan the way an HTA reviewer will.

We'll walk you through Keystone on a sample oncology asset, from source documents to a signed-off, exportable plan.

  • A 30-minute walkthrough with the product team
  • Bring a current gap list and we'll show you where the open questions are
  • Demo data is fictional. No patient or payer data is used.

We'll only use your details to arrange the demo.

Request received

Thanks. We'll reply within two business days to schedule your walkthrough.