admin

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 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 »

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 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 »

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 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 »

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 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 »

The Full-Service CRO Model Is Being Stripped for Parts. Here’s Who’s Doing the Stripping

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 »

FDA Just Killed the Two-Trial Rule. Most Sponsors Haven’t Noticed Yet.

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 »

AI in Clinical Trials Moved From Pilot to Production — And Most Sponsors Aren’t Ready

AI in Clinical Trials Moved From Pilot to Production — And Most Sponsors Aren’t Ready A VP of Clinical Operations spent $2.4 million on an AI platform for enrollment forecasting, site performance prediction, and protocol risk identification. The software was deployed nine months ago. Nine months later, her team still uses Excel for enrollment forecasts.

AI in Clinical Trials Moved From Pilot to Production — And Most Sponsors Aren’t Ready Read More »

The CRO You Hired in 2023 Isn’t the CRO You Need in 2026 — How the Outsourcing Model Is Breaking

The CRO You Hired in 2023 Isn’t the CRO You Need in 2026 — How the Outsourcing Model Is Breaking Your CRO contract was designed for a trial that no longer exists operationally. The market fundamentals shifted, the regulatory environment changed, and the competitive dynamics reversed. But your contract language and CRO selection criteria haven’t

The CRO You Hired in 2023 Isn’t the CRO You Need in 2026 — How the Outsourcing Model Is Breaking Read More »

FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission

FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission In December 2025, the FDA finalized updated guidance on Real-World Evidence (RWE) for regulatory decision-making. It replaced the 2017 version entirely. Most product development executives have barely noticed. That’s a mistake. This isn’t a guidance refresh. It’s a

FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission Read More »

Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong

Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong The brutal statistics have barely budged in a decade. Eighty to 85% of clinical trials fail to meet their enrollment targets. Thirty-seven percent of investigator sites under-enroll. And 11% of sites enroll zero patients. Yet the response

Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong Read More »