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 →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 […]
Read More →Key takeaways Asia-Pacific (APAC) has become one of the most attractive regions for clinical trials due to patient diversity, strong investigator networks, and lower operational costs. However, clinical trial start-up timelines remain highly fragmented across countries. Singapore remains the fastest and most predictable market for clinical trial activation due to centralized systems, parallel submissions, and […]
Read More →Triple-Negative Breast Cancer (TNBC) remains one of the most aggressive and complex forms of metastatic breast cancer, presenting major challenges for sponsors, investigators, and CROs in oncology drug development. As biomarker-driven therapies, immuno-oncology approaches, and precision medicine strategies rapidly evolve, early investigator engagement has become essential for successful clinical trial execution. Strategic collaboration during protocol […]
Read More →As four major blockbuster drugs losing patent protection in 2028, the pharmaceutical industry faces one of the most commercially significant exclusivity cliffs in recent years, with more than $56 billion in annual revenue at stake. For generic and biosimilar sponsors, this is not simply a future market event but a present strategic window that demands […]
Read More →Sanfilippo Syndrome, caused by a deficiency in one of four enzymes responsible for breaking down heparan sulfate in the brain, presents across four biochemically distinct subtypes, each with its own genetic origin, rate of progression, and clinical nuance. Despite affecting an estimated 1 in 70,000 births globally, the condition remains without a single approved disease-modifying […]
Read More →Two gene therapy approvals. Twelve months. One disease that had almost no treatment options just three years ago. That is where Epidermolysis Bullosa (EB) stands today. The field has moved fast. But the work is far from over, and the most important opportunities may still lie ahead. What Is Epidermolysis Bullosa? Epidermolysis Bullosa is a […]
Read More →Key Takeaways from this article — Amyotrophic Lateral Sclerosis (ALS) affects approximately 30,000 Americans at any given time, with about 5,000 new diagnoses each year in the US alone. — The global ALS treatment market is in an active growth phase, driven by genetic stratification, biomarker-enabled trials, and a first genotype-specific approval in 2023. — […]
Read More →