Credevo

Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Credevo, Health/Medical/ Pharmaceuticals, Singapore.

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

12/06/2026

Selective Phase I studies in APAC are not a shortcut to IND approval. They're a strategic choice about where to generate your first-in-human safety data.

Australia, India, and other APAC markets each have defined pathways for early-phase research. Which one fits depends on the asset, the regulatory strategy, and how the data will eventually be used.

What makes a Phase I work is not just the pathway. It's investigators with early-phase experience, sites with clinical pharmacology infrastructure, and safety oversight that can respond to FIH data in real time.

Credevo runs selective Phase I and First-in-Human studies across APAC and the United States, advising on market selection and managing regulatory approval through to study completion.

We've covered what sponsors need to prepare before the first dose is administered. https://credevo.com/articles/2025/01/05/first-in-human-fih-clinical-trials-key-considerations-for-sponsors/

If you're planning a Phase I study and want a grounded view on the right market and approach, we're here: https://credevo.com/contact

11/06/2026

The sponsor ruled out a market before feasibility started. Feasibility put it back.

Phase II, metabolic indication. Two markets in the plan. A third ruled out because the approval process "sounded slow."

Feasibility showed a different picture. A regulatory pathway for this indication running faster than both original markets, not because of a rule change, but because of where study volume sat and how competitive the indication was at that point in the review window.

The sponsor added the market. Regulatory approval came in before the other two. First patient enrolled there first.

Regulatory reputation by country is a starting point. Current-state feasibility is what you plan around.

We've covered what regulatory feasibility actually involves and how it changes country selection: https://credevo.com/articles/2024/12/15/regulatory-feasibility-assessment-in-clinical-trials-need-and-impact/

If you're finalising a country list and want to pressure-test it, we're here: https://credevo.com/contact

10/06/2026

A company developing an in vitro diagnostic doesn't always need enrolled patients to validate its device.

If residual samples from existing clinical workflows are appropriate, there's no recruitment, no site network, no enrolment timeline. That changes the cost, the timeline, and the regulatory pathway significantly.

Whether residual samples work depends on the device's intended use, the performance claims, and the regulatory pathway being pursued. In some cases a prospective study is necessary. In others, it isn't. Getting this right before committing to a design saves time that's hard to recover.

Credevo runs medical device studies across APAC and the United States, including IVD performance studies and device evaluation studies. Where the study type isn't determined, we advise on the right design first.

If you're developing a medical device and want to understand what study type the validation objective requires, we're here: https://credevo.com/contact

09/06/2026

An APAC oncology trial doesn't start when the first patient is enrolled. It starts about 10 months before that.

Regulatory submissions in each country run in parallel. IRB approvals happen on country-specific schedules. Databases need to be built and validated. Sites complete initiation visits before they can see a patient. Each step has a dependency.

What changes the outcome isn't speed. It's whether the team has run this process in these specific markets before. In Thailand, a well-prepared CTA moves differently from one with documentation gaps. In India, CDSCO oncology queries follow patterns experienced teams know. In South Korea, the MFDS review has its own rhythm.

The study isn't starting in one place. It's starting in four at once.

Credevo manages full-service Phase II and III oncology trials across APAC and the United States, with startup managed centrally from Singapore.

We've written about what makes APAC the right environment for oncology research, including what affects startup timelines: https://credevo.com/articles/2023/12/05/clinical-trials-in-oncology-why-asia-pac-stands-out-as-the-destination-of-choice/
If you're planning an oncology study in APAC, we're here: https://credevo.com/contact

08/06/2026

The regulatory timeline in the guidance document is not the timeline your study will run on.

Every APAC country has a published framework. What the frameworks don't describe: query response times in practice, current review backlogs, documentation gaps most commonly flagged, which markets are running faster or slower right now.

Sponsors working off published timelines instead of current on-ground experience pay for that gap in delays they didn't plan for.

We've covered what clinical operations in APAC actually look like, including country-specific challenges: https://credevo.com/articles/2025/08/15/mastering-clinical-operations-in-asia-pacific-overcoming-challenges-with-smart-solutions/
If you're building a timeline for a study in Malaysia, Thailand, India, or Sri Lanka, we can share what we're currently seeing: https://credevo.com/contact

05/06/2026

A sponsor building APAC clinical capability for the first time usually comes in with SOPs designed for somewhere else.

The US and EU frameworks are in the documentation. What's missing is the APAC layer. Country-specific regulatory requirements, local IRB processes, monitoring expectations in Thailand, India, or Malaysia. A CRO that applies the sponsor's global SOPs without flagging the gaps creates compliance risk without naming it.

What works is a review before the first site opens. Which parts apply to the APAC context directly? Where does a country-specific supplement need to be written? Where is the CRO operating under its own SOPs with documented sponsor agreement? What triggers a review when something changes?

This doesn't need to add weeks to startup. It needs to happen before ex*****on begins.

What a QMS framework looks like in APAC practice, including what global SOPs typically miss: https://credevo.com/articles/2025/03/15/quality-by-design-in-clinical-trials-building-maintaining-a-qms-framework/

If the SOP integration hasn't been fully worked through for your first APAC study, we're here: https://credevo.com/contact

04/06/2026

RWE studies and interventional trials run differently from day one. That difference needs to be designed in, not added after.

An observational study doesn't randomise patients. It captures what happens in routine clinical practice. Sites report what they do. Data comes from EHRs, registries, claims, patient-reported outcomes. The statistical approach handles confounding differently from a randomised design. The evidentiary standard and regulatory acceptance are different.

This matters at the design stage. A Phase IV post-marketing study required by a regulator has its own protocol structure. A PMCF study for a medical device under EU MDR has specific requirements. An RWE study supporting label expansion needs a design the relevant authority will accept.

Credevo runs RWE studies across APAC and the United States, including Phase IV studies, registry studies, PASS, and PMCF studies for medical devices.

We've written about how real-world data trial designs work in practice: https://credevo.com/articles/2022/04/15/trial-designs-using-real-world-data-rwd/

If you're planning an RWE study and want to think through the design requirements, we're here: https://credevo.com/contact

03/06/2026

The protocol looked right on paper. The problems appeared four weeks after the first patient was enrolled.

An eligibility criterion that excluded more patients than expected. A stratification structure site coordinators couldn't apply consistently. A comparator arm the investigators flagged at the SIV as no longer reflecting local standard of care.

These aren't errors. They're what happens when a protocol is finalized without input from the people who will run it.

The way to catch them is to engage investigators before lock. Not at SIV. Before. They'll surface what looks clean on paper but doesn't hold on the ground.

Credevo runs early investigator engagement as part of the full-service model and as a standalone service across all 13 operating markets.

We've covered what early site engagement surfaces before protocol lock, including how it affects comparator arm and eligibility design: https://credevo.com/articles/2025/05/15/why-early-site-engagement-matters-insights-into-soc-comparator-arms-and-site-interest/

If your protocol is at a stage where investigator input would still be useful, we're here: https://credevo.com/contact

02/06/2026

Most guidance on APAC clinical trials is written for sponsors who already know the region.

For a small biotech doing their first APAC study, the more useful starting point is knowing which decisions are being made on information that won't hold once ex*****on starts.

Published regulatory timelines are not planning timelines. Country-level epidemiology doesn't predict site-level patient availability. Investigator relationships built before the study starts change how the study runs.

The gap between what's written down and what actually happens tends to be wider in APAC than in markets where sponsors have more accumulated experience.

We've written about what APAC clinical operations actually require to go well: https://credevo.com/articles/2023/08/25/choosing-asia-pacific-for-your-clinical-trials-strategic-insights/

If you're planning your first APAC study, we're here: https://credevo.com/contact

01/06/2026

A sponsor had their country list set before feasibility started. Three weeks in, two of the four markets changed.

The assumptions hadn't been tested. Site landscapes had shifted. Investigators had moved. Competing trials had filled the relevant recruitment windows. One country's regulatory timeline for this study type had changed, not because the rules changed, but because review volumes had.

Two replacement markets worked better. The study started within two weeks of the original plan.

Feasibility isn't a box to tick. It's the work that makes everything else reliable.

We've covered what rigorous APAC feasibility looks like in practice, beyond the standard questionnaire: https://credevo.com/articles/2025/07/25/beyond-the-feasibility-questionnaire-rethinking-feasibility-assessments-in-asia-pacific-trials/

If you're selecting countries for your study, we're here: https://credevo.com/contact

Address

Singapore

Website

https://credevo.com/

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