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Book Your Clinical Momentum Call

Media & Speaking

Book Your Clinical Momentum Call

Media & Speaking

Book Your Clinical Momentum Call

oncospire consultants

The Critical Path Visibility Diagnostic

15 questions. Five minutes. The clearest picture you will get of your CRO oversight gaps without doing an internal audit.

Who this is for: VPs of Clinical Operations, COOs, CEOs, and CFOs running oncology trials with 1 to 3 CROs and a lean internal team.

What you will get: A score, a Visibility Profile, the three specific gaps your score typically reveals, and a clear next step.

What you will not get: A sales call. A demo trap. Your email forwarded anywhere. This is your diagnostic, run on your own time.

Answer each question honestly. There is no right answer. There is only the answer that matches your operation today.

0 of 15 answered

1Critical Path Visibility

The five questions your team should be able to answer in under 60 seconds.

1. If your CRO missed a milestone today, would you know before they told you?

Always. We have leading indicators in place.4 pts Usually, within a few days.3 pts Sometimes. Depends on the milestone.2 pts Rarely. We typically learn from their reports.1 pt

2. Can you name the 8 to 12 decisions that will determine whether your program hits its next inflection point?

Yes, and they are documented and tracked.4 pts Yes, but mostly in my head.3 pts I could name some of them.2 pts Not really. We manage decisions as they come up.1 pt

3. In your last CRO status call, did you get answers, or did you get updates?

Answers to specific questions we drove.4 pts Mostly answers, some updates.3 pts Mostly updates, some answers.2 pts Mostly updates. The agenda was theirs.1 pt

4. If your CEO asked "are we on track?" right now, could you answer with data you can defend?

Yes, with data I can show on the spot.4 pts Yes, but I would caveat some of it.3 pts I could give a directional answer.2 pts I would need to go back to the CRO first.1 pt

5. Do you know which sites are at risk of missing enrollment before the CRO's monthly report tells you?

Yes. We track leading indicators ourselves.4 pts For most sites, yes.3 pts For some sites.2 pts We learn from the monthly report.1 pt

2Systems and Documentation

Whether your operation can survive turnover and scale.

6. Can a new clinical operations hire be productive in 30 days?

Yes. We have documented workflows and onboarding.4 pts Yes, with significant support from existing team.3 pts It typically takes 60 to 90 days.2 pts Much longer. Knowledge lives with key people.1 pt

7. Are your core clinical operations workflows documented?

Yes, comprehensively.4 pts The critical ones are documented.3 pts Some are documented.2 pts Workflows exist in people's heads.1 pt

8. Do you have a single source of truth for trial status across all your CROs?

Yes. Internal and updated in near-real time.4 pts Yes, but it requires manual aggregation.3 pts We rely on CRO dashboards.2 pts Status lives in different places we have to chase.1 pt

3CRO Performance and Accountability

Whether you are running your CRO, or your CRO is running you.

9. Can you connect CRO spend to trial progress in under 30 minutes?

Yes, with current data.4 pts Yes, with some preparation.3 pts Within a few hours.2 pts It takes days or longer.1 pt

10. Are vendor recommendations from your CRO being independently validated by your internal team?

Yes, every significant recommendation.4 pts For major decisions, yes.3 pts Sometimes, depending on the decision.2 pts Rarely. We tend to defer to their expertise.1 pt

11. Do you have early warning systems for timeline slips with defined triggers and thresholds?

Yes, with defined triggers and thresholds.4 pts Yes, but informal.3 pts We rely on the CRO to flag issues.2 pts We typically find out after a slip has occurred.1 pt

12. Do your CRO reports answer the questions your board actually asks?

Yes. We have structured reporting around board questions.4 pts Mostly, with some translation needed.3 pts We have to rebuild the narrative for the board.2 pts There is a significant gap between what we get and what we need.1 pt

4Risk Detection and Response

Whether your operation can absorb stress without breaking.

13. Are critical processes documented and backed up so you could replace key personnel within 60 days?

Yes. We are not dependent on any single person.4 pts For most roles, yes.3 pts For some roles.2 pts Loss of key personnel would significantly disrupt operations.1 pt

14. Could your operation absorb a 2x workload increase (additional trial, scope expansion) without breaking?

Yes. Our systems and team scale.4 pts With some additional hiring.3 pts We would feel significant strain.2 pts We are already at capacity.1 pt

15. Could you make the case to a sophisticated investor that your oversight method is FDA-defensible and risk-managed?

Yes, with documentation ready to share.4 pts With some preparation.3 pts I would need to do significant work to assemble that case.2 pts I would have real concerns about that conversation.1 pt

Building clinical momentum, one oversight decision at a time. Nathalie Riebel | Oncospire Consultants

Sources for benchmarks: Tufts Center for the Study of Drug Development; Comprehend Systems CRO Oversight Survey, Applied Clinical Trials. Conservative estimates used throughout. Actual results vary by company-specific factors.

Oncospire Consultants LLC.contact@oncospire.net

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