Clinical Trial Support

No. The distinction is a legal one. In the United States, 21 CFR 312.3 defines a contract research organisation as a party that assumes one or more sponsor obligations, and 312.52 provides that a CRO which does so is subject to the same regulatory action as a sponsor. We accept no such transfer.

In India the requirement is stricter: since 1 April 2025, Chapter VA of the amended New Drugs and Clinical Trials Rules makes CDSCO registration mandatory for any organisation conducting trials or bioequivalence studies on a sponsor’s behalf. We produce documentation, analysis and evidence; you remain the sponsor and hold every obligation.

They go to a contracted CRO, a site management organisation or your own team, and we work alongside them. Monitoring, site management, patient recruitment, investigational product handling and safety case processing of record all sit there.

This is a normal division of labour, and sponsors routinely commission documentation and evidence work separately from trial conduct.

Several ICH guidelines have changed recently, and much of the material in circulation has not been updated. E6(R3) replaced E6(R2), with Annex 1 effective in the EU in July 2025 and Annex 2 from January 2027. M11 became the harmonised protocol standard at Step 4 in November 2025. CONSORT and SPIRIT both moved to 2025 versions, the Declaration of Helsinki was revised in 2024, and GPP 2022 replaced GPP3.

For device sponsors the most significant change is ISO 14155: the 2020 edition is withdrawn and the fourth edition was published in March 2026. A clinical investigation plan written to the withdrawn version is likely to draw an inspection finding.

Yes, and it is a common point of entry. Amendments, interim reports, DSUR and annual reports, a results record that is approaching or past its deadline, or a CSR for a trial that finished some time ago.

If the trial is already under way, a disclosure check is usually the first step, because registry deadlines apply regardless, and FDA has moved from pre-notice letters to notices of noncompliance.

You do. Registry records are drafted and filed on your account under your responsible party; regulatory content is prepared for your signature; the protocol and the CSR carry your name.

This matters because obligations that are not transferred in writing remain with the sponsor, and an unclear oversight chain is itself something inspectors record.

Both. Sample size and power, randomisation schedule specification, the analysis plan with the estimand framed under E9(R1), and independent analysis against your locked dataset with tables, listings and figures.

We do not own the clinical database. Database build, validation, lock and custody as the system of record remain with your data management function or CRO, and we analyse the locked data.

Eligibility criteria against the population each one excludes; endpoints against whether an estimand exists for them; the schedule of assessments against which procedures map to an objective; and the registration and disclosure obligations the geography creates.

Those four account for most avoidable amendments. The 2016 Tufts work found 45% of amendments avoidable, and the more recent data shows the count rising rather than falling.

Yes. Device studies are built to ISO 14155:2026, 21 CFR 812 and EU MDR rather than to ICH E6 alone, with the significant-risk determination driving whether a full IDE is needed.

For supplement and nutraceutical studies the first question is whether an IND is required, which depends on the claim under study rather than on the product: a structure-function claim generally does not require one, and a disease claim generally does. We will advise which applies to your protocol before the study is designed.