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Clinical development plan roadmap from preclinical to filing with key decisions locked

Design the trial that gets to approval.

Fewer than one in ten compounds that enter Phase 1 reach approval. We build the clinical development plan and trial design that put the odds on your side, from preclinical to filing.

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Lead with clarity: a strategic CDP

Our process

A clinical development plan is your comprehensive strategy from first-in-human to submission. We pair our proprietary platforms with senior medical expertise to build it with speed and precision, and to keep every decision pointed at the label you want.

Review the preclinical profile

We analyse the early pharmacology, toxicology and safety data to set the trial strategy.

Define the therapeutic use

Using InovaLandscape and medical expertise, we pin down the population, disease and outcomes, with live intelligence on prior and ongoing trials.

Design the clinical trial

We choose the endpoints, inclusion and exclusion criteria and sample size, then define what constitutes proof of concept so go/no-go decisions are clear.

Develop timelines and budget

We design trials to fit your budget and resources, with strictly no change orders, and track competitor timelines in InovaLandscape.

Implement risk management

We identify risks early and build mitigation strategies, strengthened by early adoption of an integrated evidence plan in InoviaIEP.

Cross-functional involvement

We bring clinical, regulatory, medical affairs, operations and biostatistics together, so the plan holds up from every angle.

Interventional study designer showing trial schema with randomisation, treatment and control arms and a schedule of assessments

Try our free interventional study designer

Generate your study schema and schedule of assessments in minutes, then export both straight into your protocol.

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Free resources: the Clinical Development Planning hub

The TPP template, estimands playbook and articles on trial design choices that pay off at approval. Free, no pitch.

Explore the hub
Target Product Profile template cover showing graded attributes: indication, endpoint, comparator, differentiation, label claim

The Target Product Profile template

Every study, endpoint and decision in a strong development plan should trace back to one graded target profile. This is the template we use to build it, so your CDP is designed around the label you actually want.

✓ Grade every attribute from minimal acceptable to best-in-class
✓ Efficacy, safety, dosing, comparator, regulatory and differentiation, with traceable attribute IDs
✓ Built to align to your CDP, so every study earns its place

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Latest insights

Design for the label you want, not the trial you can run

Why the target label should drive protocol design, and how to work back from it.

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The estimands framework in plain English

Same trial, two right answers: how estimands change what your data means.

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Basket, umbrella or platform: which master protocol you can sponsor

Which master-protocol design a single-asset biotech can actually run.

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Book a 30-minute Strategy Consultation

Schedule a meeting with one of our Medical Experts to discuss your CDP and Trial Design 

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