Credevo

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A global Clinical Trial Organization (CTO) providing comprehensive clinical trial services for pharmaceuticals, biologics, medical devices and healthcare products Credevo provides strategic support for healthcare products including;

- Drugs

- Biologics

- Health Supplements (Nutraceuticals)

- IVD and medical devices

- Cosmetics

In areas of

- Regulatory

- Clinical Development

- Business Development Support

- Licensing (out-/in-)

- Feasibility

24/04/2026

Secukinumab Biosimilar Development: Strategic Considerations in Clinical Trial Design

Optimizing indication selection, endpoints, and regulatory alignment for efficient and successful development pathways

The development pathway for a Secukinumab biosimilar is often more complex than it appears. While analytical and PK similarity remain the foundation, the clinical study strategy is a key determinant of efficiency, robustness, and regulatory success.

Key considerations for sponsors include:
• Selection of a clinically sensitive indication such as plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis that aligns with regulatory expectations
• Identification of endpoints that are sensitive to treatment differences while remaining operationally feasible
• Management of variability across immune-mediated disease populations and study geographies
• Alignment with global regulatory expectations to support indication extrapolation strategies

Increasingly, biosimilar development for immunology targets such as Secukinumab is moving toward optimized, indication-specific clinical strategies rather than one-size-fits-all designs. Early protocol decisions on population selection, endpoint hierarchy, and statistical assumptions directly influence timelines, sample size, and overall development risk.

📌 Key Insight:
A well-designed and scientifically aligned clinical protocol is not just a regulatory requirement, it is a critical driver of development efficiency and regulatory success.

Is your clinical protocol already aligned with the optimal design strategy for biosimilar success? If not, contact us to discuss protocol development and optimization support.

23/04/2026

Thailand’s Clinical Trial Landscape: A Strengthening Regional Hub for Clinical Development

Thailand’s clinical research environment has evolved through multiple converging improvements, making it an increasingly strategic destination for global sponsors.

Key developments include:

• Regulatory advancement: Thai FDA guidance is now more structured, with improved predictability in review timelines and responses, enhancing planning certainty for sponsors.
• Investigator capability: Oncology and infectious disease networks have strengthened through consistent participation in global Phase II and Phase III multi-center studies, building robust clinical experience.
• Patient quality metrics: High retention rates and strong protocol compliance contribute to improved data quality and study reliability.
• Infrastructure advantage: Established medical tourism infrastructure has translated into hospital systems that support clinical research at internationally acceptable standards, often without the high setup costs seen in other regions.
• Cost efficiency: Significant cost advantages remain compared to Western markets, without compromising study quality or operational rigor.

As a result, Thailand increasingly serves as a cornerstone for Southeast Asia clinical trial strategies, offering a balance of quality, efficiency, and scalability.

22/04/2026

Sri Lanka in Clinical Research: An Emerging and Underused Advantage in Asia-Pacific Trials

Sri Lanka may not appear on most sponsors’ initial clinical trial shortlists, yet its value becomes evident once studies are conducted in the market.

Regulatory timelines from submission to approval are consistently efficient, often completed in under three months, a benchmark that many larger Asia-Pacific markets do not reliably achieve. This accelerated approval pathway can significantly reduce study startup delays and improve overall development timelines.

Patient compliance culture in Sri Lanka is notably strong, contributing to lower dropout rates and higher protocol adherence. This directly supports cleaner, more reliable clinical data. In addition, investigator quality at leading institutions such as the University of Colombo and the National Hospital of Sri Lanka is well recognized across therapeutic areas including infectious diseases, metabolic disorders, and respiratory medicine.

One of Sri Lanka’s greatest advantages is its relative underutilization. Leading investigators are often less burdened by overlapping sponsored trials, patient recruitment faces less competition within the same indication, and sponsor site relationships can be more focused and productive.

For Phase II and mid-sized Phase III programs, Sri Lanka should be considered a serious and strategic inclusion in feasibility assessments.

17/04/2026

Bioequivalence Studies in Emerging Markets: Beyond Cost Considerations

The question of whether bioequivalence data from countries like India is globally acceptable has been answered. US FDA, EMA, TGA Australia, Health Canada, and several other stringent authorities accept such BE data when studies are conducted at accredited facilities following applicable guidelines. That question is settled.

What is less discussed is what this means at a pipeline level for generic manufacturers. Running BE studies in countries like India is not just a cost decision but a throughput decision. Specialist Phase I units in these regions are able to run multiple studies in parallel without the scheduling constraints typical at European CRO facilities. From protocol to first subject, timelines in our experience run 8 to 12 weeks shorter than comparable European studies.

The regulatory science depth also matters. Complex PK study designs, food effect studies, and biosimilar PK work are routinely executed at Phase I units in these regions to a standard that supports submissions across multiple global markets.

16/04/2026

India as a First-in-Human Destination: Evolving Regulatory and Clinical Landscape

India has evolved into a credible First-in-Human destination since the 2019 regulatory amendments. CDSCO review timelines have improved, and the scientific capability at select Phase I units is well established. However, the operational complexity remains significant, and sponsors approaching with a Western Phase I mindset often encounter early friction.

Key Regulatory and Operational Considerations

Several critical aspects cannot be treated as afterthoughts. India specific Subject Injury Compensation calculations must be prepared before site contracting, and the methodology is often unfamiliar to international teams.

Ethics review at many institutions follows a two layer system, involving institutional ethics committees followed by national level coordination for certain study types. In addition, import licensing for investigational products introduces an additional procedural step that can impact study timelines.

Rare Disease Trial Considerations

For rare disease programs, patient registries in India remain limited for most indications. Confirmed diagnoses are typically concentrated in a small number of tertiary academic centers.

This does not limit India’s potential, but it highlights the importance of early patient advocacy engagement and structured site feasibility planning, where most of the groundwork for successful ex*****on is established.

15/04/2026

Oncology Trials in Asia-Pacific: Beyond Cost, Toward Scientific and Strategic Value

Shifting the Narrative in Global Clinical Development

The conversation about Asia-Pacific in oncology trials has moved on. It is no longer just about cost, and sponsors still framing it that way are missing the stronger scientific and strategic argument.

Asia-Pacific accounts for over 50 percent of global cancer incidence. Countries such as India, China, Japan, South Korea, Thailand, Malaysia, Singapore, and Australia represent large and diverse oncology populations. Certain tumor types that are rare in Western cohorts are common in this region, including EGFR-mutant lung cancer, gastric adenocarcinoma, HBV-related hepatocellular carcinoma, and nasopharyngeal carcinoma.

If a drug’s mechanism of action is particularly relevant to these subtypes, conducting pivotal studies exclusively in Western populations creates a significant gap in the evidence base and limits global applicability.

Strengthening Scientific and Operational Feasibility

Beyond biology, the operational landscape has also improved significantly. Regulatory timelines in markets such as Australia, Singapore, South Korea, India, Thailand, and Malaysia have become more efficient, supporting faster study activation and ex*****on.

Investigator quality at major oncology centers across the region is now consistently aligned with global publication standards. In recent programs, inclusion of Asia-Pacific sites has reduced Phase II timelines by six to nine months.

The cost advantage remains meaningful, but it is no longer the primary driver, it is an added benefit rather than the central rationale.

14/04/2026

Retrospective Studies in Asia-Pacific: Simpler Than Commonly Perceived

Rethinking assumptions around feasibility and ex*****on in real-world settings

Retrospective studies in the Asia-Pacific region are often viewed as operationally complex by sponsors. However, in many cases, they can be executed more efficiently than expected, especially with improved access to healthcare data and increasing regulatory clarity across several markets.

With the right approach, these studies can offer faster timelines and practical pathways for generating real-world insights. The perception of difficulty often does not reflect the actual on-ground feasibility across many countries in the region.

That said, success depends on early clarity. A structured feasibility assessment before study initiation is essential to understand the real landscape.

Evaluating ethics requirements, data availability, and site-level record quality upfront helps ensure the study design is practical, efficient, and aligned with real-world conditions from the start.

13/04/2026

Real World Evidence Across Asia Pacific: Understanding regulatory and data infrastructure diversity is critical

Real-world evidence studies across the Asia-Pacific may seem attractive on paper because of large populations, diverse disease profiles, and faster feasibility. But one factor sponsors often underestimate is that data safety infrastructure is not consistent across the region.

In our recent RWE projects, we have observed major differences in pharmacovigilance ecosystems between countries. Data localization laws, patient consent requirements, and ICD coding standards vary widely, and a mature electronic health record environment in South Korea or Japan is very different from community health record systems in Indonesia or Myanmar.

Before committing to an Asia-Pacific RWE strategy, a country-by-country data quality audit is essential. Safety signal detection is only as reliable as the source data behind it, and assuming uniformity across the region is where many strategies fail. Therefore, engaging an experienced regional expert team is critical to navigate these complexities and ensure compliant, high-quality outcomes.

10/04/2026

Understanding Primary Immunodeficiency Feasibility in Asia-Pacific

Feasibility insights for Primary Immunodeficiency (PID) trials across Asia-Pacific reveal a more nuanced picture than standard questionnaires capture.

Many sites track PID patients informally, without registries or consistent coding. Patients on long-term IVIG may be recorded under recurrent infections or hypogammaglobulinemia rather than PID. Broad chart reviews can reveal more eligible patients, informing site selection decisions.

Genetic confirmation of PID subtypes is often limited. Sponsors who consider both phenotypic and immunological confirmation tend to find more eligible patients than those relying on genotypic confirmation alone.

Advocacy and patient networks are smaller than in Europe or North America, so physician-led identification remains the primary recruitment mechanism. Investigator experience and engagement are critical in this context.

Designing PID trials with these regional realities in mind can strengthen site selection and protocol planning.

09/04/2026

IVD Device validation in ASIA-PAC

Running an IVD validation study for dengue, chikungunya, Zika, or similar infectious diseases? Southeast Asia, particularly Thailand, provides consistent real-world cases that allow testing across different stages of infection, from early antigen positivity to later seroconversion.

Access to real clinical presentations is critical for accurate evaluation of diagnostic devices. Thailand’s Ministry of Public Health maintains detailed infectious disease surveillance data, supporting site selection and statistical assumptions in trial design, often required for EU IVDR submissions and WHO EUL dossiers.

Regulatory and ethics approvals in Thailand are generally faster, helping sponsors accelerate study initiation and maintain timelines.

Laboratory infrastructure at sites is well-established, and sophisticated reference labs, including AFRIMS and affiliated government facilities, provide PCR and serology testing that meets EU Notified Body standards, ensuring robust and reliable diagnostic accuracy data.

08/04/2026

The Data Is Pointing to APAC

Something is shifting in global clinical trial strategy, and the numbers are making it very clear.

Asia-Pacific feasibility assessments are consistently returning results that outperform benchmarks on three measures that matter most to sponsors: site activation speed, investigator availability, and patient recruitment in rare disease and oncology.

In fact, our own recent feasibility work in rare diseases across the region is reinforcing this trend, with results that have exceeded initial expectations in terms of investigator engagement, registry depth, and access to treatment-naïve patient populations.

The regulatory picture has changed too. ICH E6(R3) adoption has given the region a consistent GCP foundation across markets. Harmonisation is ahead of where most sponsors expected it to be.

The result is a region where patient access, investigator engagement, and regulatory infrastructure are all moving in the same direction at the same time.

That combination is increasingly scarce. It should be in your feasibility model.

Have you considered Asia-Pacific for your next program?

07/04/2026

2027 is closer than your ANDA timeline allows.

Some of the most commercially significant drug patents expire in 2027, and over 140 companies are already developing products for these opportunities. The race to file first-to-market ANDAs is underway.

For generic manufacturers, the question isn’t whether to pursue these opportunities, but whether your development, bioequivalence protocols, and regulatory strategy are ready to compete. Key considerations:

> BE study design: Follow the latest FDA Product-Specific Guidance. Outdated protocols mean designing for a moving target.
> Reference drug sourcing and characterization: Early procurement, physicochemical profiling, and in vitro dissolution are critical for complex molecules.
> Highly variable drug strategy: Molecules with >30% intrasubject variability require scaled average BE approaches with replicate designs from the start.
> Bioanalytical method validation: Non-compliance drives many ANDA deficiency letters. Protocols must align with ICH Q2(R2) and FDA standards.
> Patent landscape and Paragraph IV strategy: Understanding which patents are challengeable affects filing timelines and first-to-file exclusivity.
> Pre-ANDA meeting engagement: Early FDA guidance converts uncertainty into submission confidence.

2027 patent expiries are a generational opportunity. The window to build a defensible, first-to-file ANDA package is measured in months, not years.

Have you considered all of this for your 2027 pipeline?

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https://credevo.com/

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