ICH GCP compliance consulting for clinical trials that stand up to inspection.

What it is

What is ICH GCP (E6) and what is it used for?

ICH E6 is the Guideline for Good Clinical Practice issued by the International Council for Harmonisation, the body through which medicines regulators and industry agree common technical guidance. Good clinical practice is the ethical and scientific quality expectation for trials that involve human participants: how a study is designed, approved, conducted, monitored, recorded and reported, so that the people who take part are protected and the data submitted to regulators is reliable.

In practice GCP is a quality discipline shared between several parties. A sponsor decides what the trial is for and how it will be overseen; investigators and their sites carry it out with participants; service providers take on delegated tasks. Each needs procedures, trained people, controlled records and a way to find and fix problems before they touch a participant or a dataset.

Current edition. ICH E6(R3), the third revision of the guideline. Its principles and Annex 1 were adopted at Step 4 of the ICH process on 6 January 2025, and Annex 2 has since been adopted and published. ICH adoption is not the same as local effect: each regulator implements the guideline within its own framework and on its own timetable, as the European Medicines Agency and the US FDA have done in their own guidance documents. Confirm the date that applies to your studies with the regulator concerned.

Who it is for

Who needs ICH GCP compliance?

Any organisation that sponsors, conducts or supports clinical trials of medicines is expected to work to GCP, whether it runs one investigator-initiated study or a portfolio across several countries. The organisations that come to us usually start from one of four places:

• A sponsor or partner is qualifying you. Pharmaceutical companies and contract research organisations audit the sites, laboratories and vendors they use, and expect a working GCP system before they place a study.
• A tender or grant sets GCP as a condition. Funders and public programmes ask for evidence that trial conduct and data handling meet recognised expectations; the proposal needs more than a training log.
• A regulatory inspection is planned or possible. A marketing application, a notified inspection or a routine programme puts your trial records in front of an inspector, and the system has to stand on its own.
• A group company or new market expects one approach. Sites and affiliates in different countries follow different procedures, and E6(R3) is the moment to bring them onto one system.

Requirements

What are the main ICH E6(R3) requirements?

E6(R3) is organised in three parts. The list below is a plain-language map of that structure; during the programme your procedures and records are checked against the guideline text itself, and against any national rules your regulator applies alongside it.

• Principles of GCP: the overarching expectations that frame every trial, centred on protecting the people who take part and on producing results that can be relied on.
• Annex 1: the detailed expectations that put the principles into practice for each party involved in a trial, read according to the role your organisation plays.
• Annex 2: additional considerations published as a separate annex, which a sponsor reads with the principles and Annex 1 when a trial's design calls for it.

Whichever parts apply, the test is the same: can each party show who was responsible for what, that decisions were proportionate to the risks to participants and data, and that problems were found, investigated and corrected?

Getting inspection-ready

How do you achieve ICH GCP compliance?

There is no certification audit at the end of a GCP programme. Readiness is shown in sponsor audits and, where it happens, a regulatory inspection of your studies. Sterling helps build and run the system; the regulator alone inspects and reaches conclusions.

1. 01
   Define your role and the studies in scope.Confirm whether you act as sponsor, site, contract research organisation or vendor, the countries and regulators involved, and the studies the system must cover.
2. 02
   Gap analysis: compare current practice with E6(R3).The gap analysis reads your SOPs, oversight arrangements and trial records against the guideline, keeps what works and sets actions, owners and dates.
3. 03
   Build the clinical quality system.Write or revise procedures, set up risk-based oversight of studies and vendors, and train everyone with trial duties.
4. 04
   Audit and correct.Internal audits of processes, studies and suppliers, with deviations and CAPA closed on evidence before an external party looks.
5. 05
   Prepare for inspection and keep the system running.Mock inspections, front-room and back-room preparation and ongoing audits, so sponsor audits and regulatory inspections meet a system in daily use.

Check the route before you sign. No organisation can be certified to ICH GCP, so treat any offer of a "GCP certificate" for your company as a warning sign. Inspection outcomes come from the regulator, through its own channels; confirm them there, not from a provider's paperwork. How to choose a credible GCP consultant

Cost

How much does ICH GCP compliance cost?

A single site refreshing its SOPs and a sponsor overseeing vendors in several countries face different tasks, so there is no sensible list price. What we commit to is an all-inclusive proposal with every component shown.

Timeline

How long does ICH GCP compliance take?

Timing depends on your role, the studies already running, the state of your procedures and how much time study teams can give while trials continue. As an estimate, building or re-basing a GCP quality system to the point of inspection readiness takes four to nine months; live studies usually set the pace, because changes have to be introduced without disrupting participants.

If a sponsor audit or inspection is already scheduled, tell us at the start; we will say what can be ready and what cannot.

Your engagement

What your ICH GCP engagement includes

Your engagement runs on Sterling OS™. You choose one level of support: Design™, where our consultants guide your team through the build, or Drive™, where we manage the work and your people review and own the result. Either way Effivity is the Automate™ layer from the first day, and Sustain™ keeps procedures, training and audits current between inspections.

• Scope, gap analysis and plan

  Your role, studies and regulators confirmed, with actions, owners and dates agreed.

• Clinical quality procedures

  SOPs and forms written for how your teams run trials, not copied from a generic set.

• Effivity ISO & GRC software

  Documents, training, audits and CAPA in one workspace, included with the engagement at no additional cost.

• Training for everyone

  Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Internal and vendor audits

  Conducted or facilitated as agreed, with findings closed on evidence.

• Inspection readiness

  Mock inspections, front-room preparation and support as sponsor audits or inspections approach.

Sterling does not certify, inspect or approve anything; no GCP certificate exists, and inspection conclusions remain with the regulator. Where legal questions arise, we work alongside your legal and regulatory advisers.

Often combined with

Standards organisations pair with ICH GCP (E6)

• 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
• ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• EU IVDR 2017/746EU IVDR compliance consulting for IVD manufacturers: performance evidence, QMS, traceability and post-market follow-up prepared for your notified body.
• EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
• FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.