Allphase - Quality Assurance

Quality Assurance

The Allphase Clinical Research Quality Assurance Team strives to provide thorough coverage for both our internal and external clients’ compliance oversight. Our team brings practical application of the applicable regulations and guidances to your attention through carefully planned audits and detailed reports. The Allphase QA department is at arms-length to the clinical operations team and reports directly to the President. Independent audits of clinical investigational sites, in-house processes and documentation provide an objective assessment of the quality of the data collected and processed as part of a submission. Our experienced staff provides a comprehensive Quality Assurance service program including:

Evaluation and auditing of GCP quality processes:

•	Vendor qualification and due diligence audits (CROs, central IRBs, clinical/ diagnostic laboratories, centralized ECG/PFT readers, clinical data management, clinical supplies distributors)
•	Clinical investigator site audits
•	Clinical data management process audits
•	Clinical study report and regulatory submission document audits
•	Systems audits (pharmacovigilance and drug safety reporting, computer system validation documentation compliance, clinical research operations)

Standard Operating Procedure (SOP) and policies development:

•	Clinical research SOP gap analyses and needs assessment
•	Facilitation of SOP/policies development, approval process, distribution and training activities
•	Collaborative design and writing of customized SOPs and policies