Frequently asked questions

Yes. UK regulations (the Medicines for Human Use (Clinical Trials) Regulations 2004) require appropriate insurance or indemnity to be in place before a clinical trial can begin.

Typically clinical trial liability insurance covering harm to participants, plus appropriate professional indemnity. The exact cover depends on the trial's phase, design, and risk.

It varies widely with the trial's phase, number of participants, indication, and risk profile. We help you scope the right cover and arrange competitive quotes rather than guessing.

At minimum, sponsors need SOPs covering trial oversight, monitoring, safety and adverse-event reporting, data management, document control and archiving, vendor oversight, and quality management. The exact set depends on your trial type and how much you outsource.

From scratch it can take several months. Starting from proven templates and tailoring them, most sponsors can have a working, GCP-compliant SOP set in days to a few weeks.

Usually yes. Even when a CRO runs operational activities, the sponsor keeps oversight responsibilities and needs SOPs governing how it selects, manages, and oversees vendors.

Usually yes, but rarely a rewrite. Most pre-R3 procedures are structurally sound and need reworking around risk-based quality management, sponsor oversight of delegated activities, and data governance. A gap assessment against E6(R3) will tell you which procedures need revision and which can stand as they are.

Almost any trial activity can be delegated, but accountability cannot. The sponsor remains responsible for the conduct of the trial regardless of who performs the work, so you need procedures governing how vendors are selected, managed and overseen even when the operational work sits entirely elsewhere.

Fewer operational procedures, more oversight ones. A highly outsourced sponsor needs SOPs covering service provider selection and management, CRO governance, risk and quality management, safety oversight, the trial master file, quality events and CAPA, and inspection readiness — the responsibilities you cannot hand over.

Through documented decisions rather than assurances. Inspectors look for evidence that you selected the vendor deliberately, defined the split of responsibilities in writing, monitored performance against it, and acted when something went wrong. Oversight procedures exist to make that trail a by-product of how you already work.

It depends how far they have drifted from practice. Where procedures are broadly sound but pre-date current expectations, revision is faster and preserves institutional knowledge. Where they were inherited, never really followed, or describe an organisation you no longer are, starting from proven templates is usually quicker.

Editable, version-controlled Word files customised to your organisation, together with the forms, templates and checklists that go with them. They are yours to maintain — nothing is locked to a platform or dependent on us to change. An optional annual review service keeps them current if you would rather not track regulatory change yourself.

Yes. The templates are aligned to ICH E6(R3), FDA clinical trial regulations (21 CFR Parts 50, 56 and 312) and the EU Clinical Trial Regulation, and can be adapted for other jurisdictions. Sponsors running multi-region trials generally need one system that satisfies all of them rather than three that conflict.

Fewer than most teams expect. A sponsor package typically runs to around two dozen procedures spanning quality management, training, risk, vendor oversight, regulatory and ethics submissions, site management, the trial master file, monitoring, safety, data integrity, deviations and audit. The right number depends on how much you do yourself.

Version-controlled SOP templates aligned to ICH E6(R3) and customised to your organisation, plus the forms, checklists and supporting documents that make them usable day to day. Delivery is phased with core procedures first, and each phase includes a round of consolidated review so the set reflects how your team actually works.

A clinical Quality Management System is the documented framework — quality manual, policies, SOPs, and records — that ensures trials are conducted consistently and in line with GCP and regulatory expectations.

Regulators expect quality management from day one of clinical development. The system can be lightweight early on and scale as you grow, but it should exist before you start trial activities.

SOPs are the individual procedures; the QMS is the overarching system that organises them — the quality manual, policies, document control, CAPA, and risk processes that give your SOPs structure and oversight.

Identifying the factors that genuinely affect participant safety and data reliability in your trial, then concentrating controls there rather than applying the same intensity everywhere. It is a proportionality principle: a single-site early-phase study should not carry the same quality apparatus as a global programme.

That your documented processes match what your team actually does, and that you can show it. Audit readiness is less about having documents than about traceability: decisions recorded when they were made, procedures followed as written, and evidence retrievable without a scramble.

Start with a gap assessment against current expectations, close what it finds, and make sure your team has been trained on the procedures they are working to. Most first-inspection findings are unexciting: missing training records, uncontrolled documents, and oversight decisions that were made but never written down.

Earlier than most teams expect, and certainly before a first clinical investigation. A quality system does not have to be complete to be useful — starting with essential procedures and scaling in stages avoids both the cost of premature complexity and the risk of retrofitting one under time pressure.

They cover different ground and you may well need both. ISO 13485 governs the quality system for designing and manufacturing the device; GCP procedures govern how a clinical investigation is run. Device companies running trials usually need their clinical procedures to sit alongside, and reference, the device QMS.

E6(R3) is the current revision of the ICH Good Clinical Practice guideline. It restructures GCP around risk-proportionate quality management, strengthens expectations on sponsor oversight of delegated activities, and modernises requirements for data governance across the trial lifecycle. The principles are unchanged; how you are expected to evidence them has moved on.

Sponsors remain accountable for trial quality even where activities are delegated. E6(R3) expects you to identify what genuinely affects participant safety and data reliability, manage those risks proportionately, and show documented oversight of every vendor and CRO acting on your behalf.

Often yes, and many sponsors do. A single-site or early-phase study can be run in-house with a proportionate set of procedures covering the functions you are performing yourself. The question is not whether you are permitted to, but whether your quality system covers what you have taken on.

Usually your trial master file, your SOP list with version history and the training records against it, and evidence of sponsor oversight wherever activities were delegated. Those first requests test whether your quality system is real and current, not whether it is comprehensive.

A structured review of your existing procedures and quality infrastructure against current GCP expectations, producing a prioritised list of what is missing, outdated or unused. It is worth doing first when you already have SOPs. If you are starting from nothing, it is usually faster to build than to assess.

Anyone contributing to a trial needs GCP training proportionate to their role. In practice that means core principles for the wider team and deeper coverage for clinical operations — sponsor responsibilities, risk-based conduct, data integrity, informed consent and safety reporting — with records kept to evidence it.

There is no universal interval, but refresher training every two to three years is a common expectation, and always when the guideline changes materially. The move to E6(R3) is exactly that kind of change: teams trained under R2 have been trained against expectations that have since been superseded.