Tag: ICH E2B(R3)

Drug-Device Combination INDs: US Submission Nuances & Traps

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Drug-Device Combination INDs: US Submission Nuances & Traps Drug–Device Combination INDs in the US: Practical Nuances, Hidden Traps, and an Inspection-Ready Playbook Why combination INDs are different—and how to avoid the traps that stall review Begin with PMOA and jurisdiction: the decision that shapes everything else Combination development succeeds or slips based on a single…

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US Regulatory Submissions

Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy

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Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy Bridging Foreign Data into a US IND: An Inspection-Ready Strategy for Acceptability, Traceability, and Real-World Timelines Why bridging foreign data is a speed lever—and how to make it acceptable the first time Start with the regulatory outcome, then design the bridge For many sponsors, the…

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US Regulatory Submissions

IND on a Budget—What Not to Cut (Small Sponsor Tactics)

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IND on a Budget—What Not to Cut (Small Sponsor Tactics) IND on a Budget—Smart Cuts, Not Blind Cuts: Small-Sponsor Tactics that Preserve Speed and Reviewability Outcome-Oriented Budgeting: Buy Time, De-Risk Holds, and Keep Your First-Patient-In Date Define the decision gates before you cut a dollar Lean programs win by funding decisions, not documents. Before trimming,…

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US Regulatory Submissions

Rare-Disease Enrollment Playbook: Windows, Support, Partnerships

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Rare-Disease Enrollment Playbook: Windows, Support, Partnerships Rare-Disease Enrollment Playbook: Managing Windows, Building Support, and Structuring Partnerships That Actually Deliver Why rare-disease enrollment is different—and the operating model that makes it predictable What breaks in “business-as-usual” enrollment for rare conditions In rare diseases, enrollment fails for structural reasons: low prevalence spread across wide geographies, heterogeneous diagnostic…

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Clinical Trial Operations & Data Integrity, Study Operations & Enrollment

US vs EU Early Advice: FDA Meetings vs EMA Scientific Advice

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US vs EU Early Advice: FDA Meetings vs EMA Scientific Advice Early Advice Pathways Compared: Getting Actionable FDA Meeting Outcomes vs EMA Scientific Advice (with UK/Global Notes) Why early advice determines your development velocity—and how to aim for decisionable outcomes Begin with a decision map, not a calendar Whether you pursue US or EU first,…

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US Regulatory Submissions

Right-First-Time IND Cover Letters & Cross-References (US-First)

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Right-First-Time IND Cover Letters & Cross-References (US-First) Right-First-Time IND Cover Letters and Cross-Reference Strategy: A US-First, Inspection-Ready Playbook Why the IND cover letter is your speed lever—and how to write one that gets triaged fast Start with decisions, not descriptions The best IND cover letters are not courtesies; they are decision memos disguised as letters….

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US Regulatory Submissions

Investigator Meeting Content Map: Drive Screen Quality Day-1

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Investigator Meeting Content Map: Drive Screen Quality Day-1 Investigator Meeting Content Map to Drive Day-1 Screening Quality (and Keep It Inspection-Ready) What an Investigator Meeting must deliver: reproducible screen quality from the very first patient The outcome we’re buying with an IM The point of an Investigator Meeting (IM) is not inspiration—it is repeatable performance….

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Clinical Trial Operations & Data Integrity, Study Operations & Enrollment

Type A/B/C Meetings: Questions That Get Actionable FDA Feedback

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Type A/B/C Meetings: Questions That Get Actionable FDA Feedback Type A/B/C Meetings: Crafting Questions That Get Actionable FDA Feedback the First Time Outcome-first framing: the fastest path to “clear, actionable” answers Start with the decision you want, then write backwards Every successful Agency interaction starts with a decision list: what you want the review team…

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US Regulatory Submissions

IDE vs IND: Device vs Drug Pathways—How US Sponsors Decide

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IDE vs IND: Device vs Drug Pathways—How US Sponsors Decide IDE vs IND in the US: A Practical, Inspection-Ready Playbook for Choosing Between Device and Drug Pathways Outcome-oriented framing: how to pick the right pathway without losing months Start with the clinical objective and primary mode of action (PMOA) The fastest route to first-patient-in is…

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US Regulatory Submissions

Country Mix Optimization: Add Sites with Predictable Gains

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Country Mix Optimization: Add Sites with Predictable Gains Country Mix Optimization: How to Add Sites That Deliver Predictable Gains (Not Just More Complexity) Outcome-first site expansion: when adding countries lifts velocity—and when it only adds noise The real question: will a new country raise weekly randomizations with confidence? “Add more sites” is a reflex; “add…

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Clinical Trial Operations & Data Integrity, Study Operations & Enrollment