At CCA we provide services for small, mid size and large companies in the pharmaceutical, biotechnology and medical device industries. At CCA our audit services cover the following functional areas and key activities associated with the delivery of a clinical trial.

TMF Audits - As documentation and TMF issues become have more prevalent the provision and delivery of TMF Audits has become increasingly apparent and frequent. At CCA we provide a comprehensive QC and review process delivered in tandem as part of our TMF services. We provide a review or if required an audit of all essential documents in accordance with ICH GCP and EU Directive 2001/20/EC, The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005) and client SOPs. We also review the TMF assessing documentation and orientating our audit of data to support the validation effort, system security issues, and archival/backup requirements of our clients.

Investigator Site Audits - Whether it's the highest recruiting site, a pre-regulatory inspection review or a 'for cause' audit we carry out single or multiple investigator site audits for compliance and quality.

QC co-monitoring - As part of our Quality program Initiative we provide a full outsourced QC co-monitoring including the resource program to enable each client to initiate or support their in house quality initiatives.

CRO and Vendor Audits - Audit of Contract Research Organizations operations and systems to assess client satisfaction, conformance with SOPs, and regulatory compliance. Audits and evaluation of vendors prior to contracts or involving ongoing studies including systematic reviews or audits of Central Imaging and Reading Facilities (ECG, radiology, etc.) We provide Audits of Interactive Voice Response Systems (IVRS) and associated drug accountability shipping and reconciliation.

Our reports are provided at a pre agreed timelines and are generated in compliance with CCA's ISO 9001:2008 approved standard operating procedures and the specific client requirements.