Synapse Clinical Research Services

Synapse Clinical Research Services is a flexible and independent QA consultancy providing a range of independent GCP and GMP Quality Assurance audits. Services offered are tailored to meet client's needs, and include MHRA inspection preparation, internal system and facility audits, process improvement, GCP and GMP training, SOP writing and review.... Synapse also undertakes supplier audits with particular expertise and experience in Clinical Trials Manufacture and Packaging, Clinical Research Organisations, Phase I Units and Clinical Laboratories. Synapse provides a full range of clinical audits from phase I to phase IV studies. Following each audit, comprehensive and confidential reports and audit certificates are produced in accordance with client specifications. Clinical Audits offered encompass the following aspects of the clinical development process: Trial Master File Audits; Investigator Site Audits (including Pharmacy); Phase 1 Units; and Clinical Study Report Audits. Studies, service providers and systems are audited against international regulations, namely ICH GCP, the Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC and FDA 21 CFR. Consideration is also given to project specific requirements, industry expectations and relevant guidance documents.Read More