Credevo

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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

21/10/2026

A company with no presence in Japan cannot sponsor a clinical trial there under its own name. Japan's Good Clinical Practice ordinance, Article 15, requires a sponsor residing outside Japan to appoint a person in Japan eligible to sponsor the trial on its behalf, known as the In-Country Clinical Caretaker (ICCC).

The ICCC carries out the sponsor's procedures in Japan, which places it in the regulatory correspondence and in the safety reporting line for the study. Appointing one involves a contract and a defined scope of responsibilities, so it belongs in start-up planning next to ethics and regulatory preparation.

Singapore has a comparable rule in a different form. Clinical trial applications to the Health Sciences Authority are made by a local sponsor, defined as the local company or institution that takes responsibility for the initiation, management or financing of the trial.

Each market's version has its own scope, and for a sponsor without regional entities these roles can decide which markets open first.

Arranging the in-country sponsor role is part of our APAC start-up planning.

Our guide to starting Japan approvals: https://credevo.com/articles/2018/08/16/japan-clinical-trial-regulatory-process/

For a check on local sponsor requirements across your markets: https://credevo.com/contact

20/10/2026

Three eligibility criteria that each exclude 30 percent of otherwise suitable patients leave about a third of the original pool, before screening starts.

The arithmetic is multiplication. If each criterion keeps 70 percent and the criteria act independently, 0.7 × 0.7 × 0.7 is 0.34. A fourth criterion at the same rate takes the pool to 24 percent. Each criterion can be defensible on its own, a lab threshold here and a prior-therapy restriction there, and their combined effect still decides whether the planned sites can enrol on schedule.

Real criteria overlap instead of acting independently, so the true figure can be better or worse than the multiplication suggests. That is the reason to test the full set against the patients a site actually sees, instead of against published prevalence. Investigators can say from their own clinic lists which combination of criteria their patients meet, and a criterion that protects the primary endpoint can then be weighed against one that only tidies the dataset.

The check costs least before protocol lock, while a change is still a revision.

Running the full eligibility set against real clinic populations in the target countries is part of our feasibility work.

Our view on feasibility beyond the questionnaire: https://credevo.com/articles/2025/07/25/beyond-the-feasibility-questionnaire-rethinking-feasibility-assessments-in-asia-pacific-trials/

For an eligibility check before lock: https://credevo.com/contact

19/10/2026

Singapore's Health Sciences Authority (HSA) lists 30 working days to process a Clinical Trial Authorisation (CTA), and that figure counts only the days the application sits with the regulator.

HSA's published turnaround excludes the time an application is paused for queries. When a reviewer sends a clarification request or asks for more information, the count pauses until the sponsor's reply arrives. Thirty working days is also about six calendar weeks before any pause is added. For Phase 1 trials run only to evaluate bioavailability, bioequivalence, food effect or drug interactions, the listed figure is 15 working days, and a Clinical Trial Notification for lower-risk trials is 5 working days.

The part of the timeline a sponsor controls is the reply. A question on the Investigator's Brochure or a manufacturing document can be answered in a day when the source documents sit with a team that already knows the dossier, or take weeks when each answer has to be requested from a manufacturer in another time zone.

Other APAC regulators publish their own review times, and what counts toward each one is worth checking market by market before a plan is fixed.

Keeping the dossier's source documents within reach of the submission team is how we keep query rounds short.

Timelines are indicative and vary with study specifics and current regulatory requirements.

Our overview of the Singapore process: https://credevo.com/articles/2018/09/15/singapore-clinical-trial-regulatory-process/

For a start-up timeline check across your markets: https://credevo.com/contact

16/10/2026

For a class III or implantable device on the EU market, the post-market clinical follow-up evaluation report is an annual document, and the device's public safety summary is updated alongside it.

Under Article 61(11) of the EU Medical Device Regulation (MDR), the clinical evaluation has to be updated throughout the device's life with data from the manufacturer's post-market clinical follow-up (PMCF) plan. For class III and implantable devices, the PMCF evaluation report, and where indicated the summary of safety and clinical performance (SSCP) made available to the public, must be updated at least once a year.

A manufacturer can conclude that PMCF is not appropriate for a given device, and that conclusion is a documented position the notified body assesses. The Medical Device Coordination Group's PMCF plan template (MDCG 2020-7) names the justification for not performing PMCF as one of the things notified bodies review.

The practical result is a standing workstream on a fixed cadence: data collection designed so that each year's report has new data to evaluate, and a clinical evaluation report that stays in step with it.

Planning next year's PMCF data while this year's report is being written is how we set up device evidence work.

For a check on your PMCF cycle: https://credevo.com/contact

15/10/2026

If the true variability in a study's primary endpoint turns out 20 percent higher than the planning assumption, keeping the same power takes about 44 percent more participants.

That follows from how sample size works for a continuous endpoint. The number needed grows with the square of the ratio between the endpoint's variability and the treatment difference the study is built to detect. Raise the variability by a fifth and the sample grows by 1.2 squared, which is 1.44. Halve the difference to detect and the sample roughly quadruples.

ICH E9, the international guideline on statistical principles for trials, asks the protocol to state the basis of every estimate behind the calculation and to investigate how sensitive the number is to deviations from those assumptions, ideally with a range of sample sizes across a reasonable range of deviations.

For a small or mid-sized sponsor, that sensitivity range sets the realistic budget. If the variability estimate comes from one published study in a different population, the realistic sample can sit well above the headline number, and that is cheaper to learn at protocol stage than at an interim analysis.

Pressure-testing the variability estimate is where our sample size work starts.

For a check on your sample size assumptions: https://credevo.com/contact

14/10/2026

A journal that follows ICMJE rules considers a trial only if it was registered in a public registry at or before the first participant's consent.

The International Committee of Medical Journal Editors (ICMJE) requires registration in a public trials registry at or before the time of first patient consent for enrolment, as a condition of considering the paper. Accepted registries are ClinicalTrials.gov and the primary registries of the World Health Organization network, such as India's Clinical Trials Registry (CTRI). A late-registered trial can be considered only as an exception, and the paper then has to state when registration happened and why it was late.

Two more requirements attach at the same early stage. Trials enrolling from 1 January 2019 need a data sharing plan inside the registration itself, and manuscripts reporting trial results have needed a data sharing statement since 1 July 2018.

For a sponsor who plans to publish, the registry record becomes part of the paper's evidence: the outcomes registered at the start are public, so any gap between registered and reported outcomes is visible to reviewers.

Registration timing sits at the top of our publication planning checklist, well ahead of journal selection.

Our guide to manuscript writing and journal submission: https://credevo.com/articles/2026/08/15/publishing-clinical-trial-results-a-sponsors-guide-to-manuscript-writing-and-journal-submission/

For a publication planning check: https://credevo.com/contact

13/10/2026

How long a Clinical Study Report (CSR) takes to write depends largely on how many safety narratives it needs.

ICH E3, the international guideline on CSR structure, asks for a written narrative for each death, each other serious adverse event, and those other significant adverse events judged to be of special clinical interest. "Other significant" has a precise meaning in E3: marked laboratory abnormalities that fall short of serious, and any event that led to an intervention such as stopping the study drug, reducing the dose, or adding significant treatment.

Each narrative pulls together the patient's history, dosing, the event's course, concomitant medicines, relevant lab values and outcome, and each one goes through medical review. Two studies with the same design can differ by weeks of CSR effort if one has a handful of qualifying events and the other has sixty, many of them dose reductions.

That count is visible as soon as the safety listings are drafted, so the writing effort can be sized before database lock.

Narrative volume is the first number we ask for when scoping a standalone CSR.

We cover E3 structure and what regional regulators look for here: https://credevo.com/articles/2026/08/25/writing-a-clinical-study-report-in-line-with-ich-e3-structure-common-deficiencies-and-what-apac-regulators-expect/

For a CSR scoping check: https://credevo.com/contact

12/10/2026

A generic inhaler for asthma or chronic obstructive pulmonary disease (COPD) can need a very different evidence package for Europe than for the US, and the difference comes from how each regulator structures the evidence.

Since 1 February 2026, the European Medicines Agency's revised guideline on orally inhaled products uses a stepwise route. If the generic matches the reference on every laboratory (in vitro) criterion, including the particle size profile that decides how deep the drug reaches in the lung, equivalence can be concluded on laboratory data alone. If any criterion fails, the next step is pharmacokinetic studies, which measure drug levels in the blood as a stand-in for both safety and lung deposition. The guideline discourages clinical endpoint studies as too insensitive.

The FDA works product by product. Its current guidance for fluticasone propionate and salmeterol inhalation powder offers two packages: four laboratory studies with two pharmacokinetic studies, or two laboratory studies with one pharmacokinetic study and a comparative clinical endpoint study. It also expects the inactive ingredients and the device to match the reference closely.

Each approach has its own logic, and which package costs less depends on how close the product already sits to the reference in the lab.

Mapping the evidence package for each target market is where our inhalation bioequivalence scoping starts.

For a market-by-market evidence map: https://credevo.com/contact

09/10/2026

A modified-release generic headed for the US should be budgeted for two bioequivalence studies from the start, one fasting and one fed, whatever the reference product's label says about food.

The US Food and Drug Administration's (FDA) guidance on bioequivalence studies for generics recommends both fasting and fed studies for all oral modified-release products, irrespective of the dosing instructions in the reference label. The exception it allows is when serious adverse events are expected under one of the two conditions.

The reason is the formulation. A modified-release tablet holds its dose inside a coating or matrix built to let the drug out over many hours. A high-fat meal changes how long the tablet stays in the stomach and how the gut handles it, and some designs release faster than intended when that happens. A fasting study can pass while the fed study shows a different release profile, so the fed study checks that release holds up when the tablet is taken with food.

Formulation type is the first question in our bioequivalence scoping, because it decides how many studies the quote has to carry.

For a scoping check on a modified-release generic: https://credevo.com/contact

08/10/2026

A generic aimed at both the US and Europe has to show bioequivalence against two different reference products, and that shapes the study plan before the design is discussed.

For a US Abbreviated New Drug Application (ANDA), the US Food and Drug Administration (FDA) selects the reference standard, ordinarily the reference listed drug approved in the US, and the applicant tests against that exact product. The European Medicines Agency's bioequivalence guideline asks for a reference medicinal product authorised in the European Union. The US pack and the EU pack of the same brand can differ in formulation or manufacturing site, so neither regulator accepts one in place of the other.

That means two comparisons. They can run as two studies, or combine in one study with an extra dosing period, where each volunteer receives the test product and both references in turn. Whether combining works depends on the molecule's half-life and variability, because each extra period lengthens the study for every volunteer.

Reference sourcing, including documented purchase of each pack, is the first line item in our bioequivalence scoping.

For a sourcing and design check on a two-market generic: https://credevo.com/contact

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