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Inovia Bio Insights

Keep Up To Date With All Things Inovia Bio &
Drug Development

Diagram of a future-proof RWE study design withstanding evolving FDA and EMA real-world evidence guidance revisions.

RWEReal world evidenceMethodology

The principles that don't move: future-proofing your RWE against evolving FDA and EMA guidance

Inovia Bio field guide to real-world evidence bias: confounding by indication, selection bias and immortal time bias explained in plain English.

RWEReal world evidenceMethodology

The three biases that sink real-world evidence: a plain-English field guide to confounding, selection and immortal time

Rare disease clinical trial design toolkit comparing Bayesian borrowing, n-of-1 trials and platform trial statistical methods

Making small N count: the rare-disease statistical toolkit, and the price each method charges

Bevacizumab, gefitinib and gemtuzumab ozogamicin case studies illustrating the cost of not having an Integrated Evidence Plan

The Cost of Not Having an IEP: Three Failure Stories

Illustration of a hybrid control arm design: a randomised trial borrowing external control data to shrink its concurrent control arm

single arm trialsMethodology

Shrink the arm, keep the randomisation: the borrowing discipline that decides a hybrid trial

Diagram distinguishing a biotech's IEP accountable owner from its operations lead and contributors

Who should own the IEP inside your biotech? Why "the sponsor" is a fiction only you can resolve

Diagram contrasting calendar-based IEP review with event-triggered IEP governance via a named owner and trigger register

Keeping an IEP alive: a named owner, a trigger register, and why the calendar is the weakest safeguard you have

Decision tree matching real-world evidence gap types (comparator, durability, subgroup, safety-signal, patient-experience, access) to the evidence-generation tactic that closes each

RWEStrategyIEPReal world evidence

From gap list to tactic: a decision tree for evidence generation

Twelve-point external control arm design checklist for FDA and EMA regulatory submissions

RWEStrategyReal world evidenceexternal control armsregulatory strategy

The external control arm design checklist: 12 points that survive scrutiny

Inovia Bio featured image for the evidence gap audit: five axes for grading regulatory readiness in a drug development programme before FDA or EMA review.

StrategyIEPdrug development

The evidence gap audit: five axes to grade your programme before a reviewer does

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