If you run post-marketing safety studies on real-world data, you have worked without a single harmonised planning standard. Each region asked for something slightly different. For example, a protocol written for one regulator often needed rebuilding for the next. As a result, a sponsor with commitments in three markets could end up running three studies […]
Read More →You are planning a BA/BE study in India. Your regulatory timeline budgets 90 working days for CDSCO to review your test licence application. In January 2026, India’s Ministry of Health and Family Welfare changed that. They notified the New Drugs and Clinical Trials (Amendment) Rules, 2026 via Gazette Notification G.S.R. 46(E). The new rules cut […]
Read More →Your study ran. The product may well have worked. However, the primary endpoint was not met. The sample may have been too small. Or the measurement was inconsistent across sites. Or the effect size assumed in the power calculation was borrowed from a pharmaceutical dose with no relation to your formulation. The study is now […]
Read More →Your Phase II rheumatoid arthritis study is built on a protocol that worked in Europe. The comparator arm reflects European standard of care. The baseline disease activity thresholds come from US trial precedent. The site list was built from academic centres with strong track records in Western trials. You are now taking this protocol to […]
Read More →You are planning a Phase II oncology study across three APAC markets. The protocol is close to final. Now comes the part most sponsors underestimate: selecting a CRO model that gives you execution control without building infrastructure you do not have. A full service CRO APAC engagement hands you one accountable partner across every function, […]
Read More →A sponsor completes a Phase II oncology trial across three APAC markets. The data is clean, the efficacy signal is real, and the team followed the statistical analysis plan. The clinical study report takes eight weeks to draft. Six weeks after submission, the regulatory authority returns a deficiency notice. Not because the trial failed, but […]
Read More →A sponsor completes a Phase III trial with a positive primary endpoint. The database is locked, the clinical study report is filed, and the regulatory submission is in. Manuscript writing comes next. Six months later, two journals have rejected the draft. It now sits in a third journal’s review queue, and the lead author has […]
Read More →Singapore and Malaysia are the two most-cited APAC markets for sponsors planning Phase II clinical trials outside Japan, India, and Australia. Both have strong regulatory frameworks, experienced investigator pools, and GCP-compliant site infrastructure. Because they are close enough in quality to require a deliberate choice, and different enough in cost and timelines for that choice […]
Read More →Vietnam has been on the periphery of APAC clinical trial planning for most of the last decade, considered after Thailand, Malaysia, and India if considered at all. That positioning is no longer accurate. Since 2022, the Drug Administration of Vietnam (DAV) has shortened approval timelines, the ethics committee landscape has become more predictable, and investigator […]
Read More →The Functional Service Provider (FSP) model gives sponsors something that full-service CROs and pure in-house execution don’t: operational depth in specific markets or functions, without surrendering governance of the study. When sponsors use it well, they get experienced on-ground staff, maintain data and IP control, and run leaner than a full-service model allows. When they […]
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