StudioRWE by LY

RWE Feasibility Engine

Move step by step through therapy area, endpoints, data reality, India alignment, site readiness and financial buffers. You’ll get a warm, clear summary – not a verdict.

1 Study & Therapy Area

2 Endpoints & Survival

3 Data Reality & India

4 PRO (if applicable)

5 Sites, EC & Ops

6 Finance, Risk & Wrap

Step 1 · Study & Therapy Area

Study working title

Primary research question (one line)

Therapy area

Key indication / disease

Product / brand

Mechanism of action

Year of first approval (any major market)

Estimated disease prevalence in your target geography

Standard of care (SoC) snapshot (1–2 lines)

Do you want to compare your study endpoints to SoC benchmarks?

Sample size in SoC benchmark (if known)

Step 2 · Endpoints & Survival Thinking

Primary endpoint

Key secondary endpoints (comma separated)

Is your primary endpoint validated and widely accepted in this therapy area?

How critical is this endpoint for your decision-making?

Overall survival (OS) for this indication in your setting

If known, typical OS (e.g., median months or survival %) – optional

Do you plan to include patient-reported outcomes (PROs) in this study?

Step 3 · Data Reality & India Alignment

Primary data sources you plan to use

EMR Lab / LIS Pharmacy / billing Prospective registry Case files / MRD records Other

Estimated total N you plan to include

Of these, what % do you expect to have reasonably complete data?

How is your data distributed across formats?

Planned missing data strategy

How well does your endpoint + design reflect Indian clinical, epidemiological, and regulatory reality?

Step 4 · PRO Details (if applicable)

If you marked “Yes” or “Considering” for PROs, adding a bit of detail here will help the engine give sharper feedback. If not relevant, you can move ahead.

Which PRO instruments are you considering?

Mode of PRO capture

Expected baseline + follow-up completeness for PRO (%)

Step 5 · Sites, EC & Operational Health

Planned number of sites

Does your PI realistically have time for this study?

Is a KOL formally on board?

EC / Ethics approval path

Expected EC approval lead time (weeks)

Digital readiness at key sites

Step 6 · Finance, Risk & Next Steps

How confident are you in your current budget?

Approximate buffer (%) you’ve kept for contingencies

If new site-level charges or overheads emerge, do you have room to absorb them?

How many major questions above did you genuinely not have an answer for?

This is not to judge you; it simply helps the engine gently suggest whether a structured feasibility or an RWE partner could make your journey smoother and lighter.