Services

Clinical Project Management

Clinical Operations

Clinical Data Management

Biostatistics

Medical Writing

Clinical Quality Assurance

Clinical Resourcing

Functional Service Teams

Technology

Quality Assurance

Peachtree's independent Quality Assurance (QA) department is staffed by a team of experienced professionals. Our QA department is entirely separate from and independent of the personnel engaged in the direction and conduct of clinical trials. Quality Assurance’s objective is the promotion of ongoing quality awareness and continuous improvement of our corporate processes. Peachtree's QA department serves these efforts by performing audits on all of the processes and systems used in the management of clinical trials.

Our principal accountabilities are audits of Phase I to Phase IIIb/IV clinical studies to ensure compliance with study protocol, appropriate SOPs and GCP Guidelines. The scope of audit services we offer include, but is not limited to:

• Protocol & CRF Audits
• TMF Audits
• Investigator Site Audits
• Database Audits
• Clinical Study Report Audits
• System Audits (Quality Management Systems, SOP compliance)
• Vendors of critical services—Capability or performance audits; clinical supply packaging/labeling/distribution, Central Readers, IVRS, e-CRF and remote data entry systems, clinical and bio-analytical labs
• Inspection Readiness

All audits are performed to assess adherence and compliance with Standard Operating Procedures (SOPs), Good Clinical Practice guidelines, regulatory requirements, the trial protocol, client instructions, and contractual obligations.

Our QA Auditors are well trained in GCP and compliance issues and have broad auditing experience in the various audit types. Audits have been performed for a wide range of medical indications and in various countries, e.g., USA, Canada, South America, Western, Central and Eastern Europe, South Africa, India and others.