Under Rule 101 of India’s New Drugs and Clinical Trials Rules, 2019, the CDSCO can waive the requirement for a local Indian clinical trial if a new drug is already approved and marketed in a recognised country — the USA, UK, EU, Japan, Australia, or Canada — and fits a defined category. It is not
Rule 101, Decoded: When Your FDA Dossier Can Skip a Phase 3 in India Read More »
Sponsors weighing India usually start with “it’s cheaper” — which is true and almost useless as a reason to go. The real savings come from a few specific places: site and operational economics, faster enrollment in deeper patient populations, and an operating model with fewer handoffs. Where the savings do not come from — and
India vs. U.S. Clinical Trial Cost: Where the Savings Really Come From Read More »
A clinical trial run across two geographies usually means three vendors, two standards, and no single owner — and every handoff between adviser, CRO, and local agent taxes the timeline and dilutes accountability. That is the offshore CRO friction tax. The way to avoid it is an in-house CRO India model with a DCGI-registered operation,
The Offshore-Friction Tax: Why an India Trial Through Three Vendors Costs You Months Read More »
Choosing an oncology CRO in India is not about who is cheapest — it is about whose data will survive an FDA inspection. The CROs worth shortlisting share four traits: access to premier, high-volume cancer centers; in-house regulatory expertise across the FDA and India’s DCGI; a documentation standard built for U.S./EU inspection from day one;
Oncology CRO in India: How to Choose One That Meets FDA Standards Read More »
Getting a clinical trial approved in India means understanding the CDSCO Approval Process. Sponsors must submit their application through the Sugam portal, where it is reviewed by a Subject Expert Committee (SEC) before the Drugs Controller General of India (DCGI) grants permission. The process is governed by the New Drugs and Clinical Trials Rules, 2019
CDSCO Approval Process Explained: India’s Clinical Trial Pathway, Step by Step Read More »
Most oncology clinical trials that stall or fail do so because they cannot enroll the right patients fast enough — not because the molecule was wrong. The bottleneck has four parts: finding the rare biomarker-positive patient, reaching patients who live where your sites are not, moving tumor tissue through a fragile testing chain, and doing all of
Where Oncology Programs Actually Die: The Four Enrollment Bottlenecks Read More »
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 it — unless the Agency places it on clinical hold. Silence on Day 30 is the green light. First-time sponsors who sit idle waiting for an approval that never arrives lose weeks
The 30-Day Myth: Why “FDA Approval” of Your IND Doesn’t Exist Read More »
Running a clinical trial in India as a U.S. sponsor comes down to five decisions, made in the right order: get the regulatory pathway right, file with the CDSCO, choose sites on capability rather than convenience, build the operational plan around enrollment, and govern the whole thing to the standard your FDA filing will demand.
How to Run a Clinical Trial in India: A Step-by-Step Guide for U.S. Sponsors Read More »
Last quarter, a top-20 pharma company pulled biostatistics, data management, and pharmacovigilance out of a $400 million full-service CRO model. Kept the CRO for site management and recruitment infrastructure. Hired an FSP provider for everything else. The CRO’s stock dropped 3% on the earnings call when the CEO mentioned ‘evolving client preferences.’ That’s Wall Street
The Full-Service CRO Model Is Being Stripped for Parts. Here’s Who’s Doing the Stripping Read More »
February 2026. A 47-page draft guidance drops on the FDA website. No press conference. No industry call. Just a PDF that rewrites the approval playbook for every sponsor running a pivotal program. The new default: one adequate and well-controlled study, combined with confirmatory evidence, is sufficient for marketing authorization. One. Not two. That’s the end
FDA Just Killed the Two-Trial Rule. Most Sponsors Haven’t Noticed Yet. Read More »
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