Insights
Notes on oncology development and regulatory pathways
Tissue Is the Trial: Why Biomarker-Gated Oncology Studies Fail on Logistics
In a biomarker-gated oncology trial, the right patient existing is not enough — their tumor tissue has to be retrieved, shipped under controlled
Rule 101, Decoded: When Your FDA Dossier Can Skip a Phase 3 in India
Under Rule 101 India waiver New Drugs and Clinical Trials Rules, 2019, the CDSCO can waive the requirement for a local Indian clinical
India vs. U.S. Clinical Trial Cost: Where the Savings Really Come From
Sponsors weighing India usually start with “it’s cheaper” — which is true and almost useless as a reason to go. The real savings
The Offshore-Friction Tax: Why an India Trial Through Three Vendors Costs You Months
A clinical trial run across two geographies usually means three vendors, two standards, and no single owner — and every handoff between adviser,
Oncology CRO in India: How to Choose One That Meets FDA Standards
Choosing an oncology CRO in India is not about who is cheapest — it is about whose data will survive an FDA inspection.
CDSCO Approval Process Explained: India’s Clinical Trial Pathway, Step by Step
Getting a clinical trial approved in India means understanding the CDSCO Approval Process. Sponsors must submit their application through the Sugam portal, where
Where Oncology Programs Actually Die: The Four Enrollment Bottlenecks
Most oncology clinical trials that stall or fail do so because they cannot enroll the right patients fast enough — not because the molecule was
The 30-Day Myth: Why “FDA Approval” of Your IND Doesn’t Exist
There is no FDA “approval letter” for an Investigational New Drug application. Under 21 CFR 312.40(b)(1), your IND goes into effect 30 days after the FDA receives
How to Run a Clinical Trial in India: A Step-by-Step Guide for U.S. Sponsors
Running a clinical trial in India as a U.S. sponsor comes down to five decisions, made in the right order: get the regulatory
