CliniSolutions SMO & Research Organisation

CliniSolutions is a Site Management Organisation: it makes investigator sites work for sponsors and contract research organisations. The engagement starts before a study is awarded, with feasibility — an honest read on whether the protocol's eligibility criteria match the patients a site actually sees, whether the visit schedule is realistic for that population, and what the site would need to deliver the timeline being asked of it.

From award onward CliniSolutions runs the site-level work: site identification and selection, investigator and coordinator support, regulatory and ethics committee submissions, participant recruitment against enrolment targets, and the informed consent process — conducted as a conversation with time for questions, documented as the protocol requires, and never treated as a signature to be collected. Monitoring support keeps source documents, case report forms and drug accountability records ready for sponsor visits and audits rather than reconstructed before them.

Studies are closed out with the same discipline: final data queries resolved, records archived to retention requirements, and site obligations formally discharged. All of it is run in alignment with ICH-GCP, which in practice means a study is documented as it happens — the difference between a site that passes an audit and one that does not.