Clinical Affairs Services

Would you be ready if an unscheduled Inspector arrived at your site today? Or would you prefer a scheduled inspection?  A non-compliance rating can have detrimental effect on all parties and all facilities involved. Despite this, a reactive approach is still being utilized.

AXSource Consulting Inc. serves contract research organizations (CROs), hospitals, clinics, manufacturers and distributors with the development and implementation of effective clinical trial documentation.

 

For more information, contact us today!

Our clinical services include:

Regulatory Clinical Trial Applications (CTAs)

Investigator Brochure

Informed Consent Forms

REB / IRB Approval

Clinical Trial Protocols and study reports

Clinical Documentation Development

Clinical Monitoring

GCP Audits

Regulatory Inspection Readiness

Remediation Strategy

Professional Training

Clinical Data Anonymization

Clinical Data Anonymization

There is a growing demand from stakeholders for transparency, not only about Regulatory Agency deliberations and actions, but also about the clinical data upon which regulatory decisions are based. Therefore, Agencies like Health Canada and EMA have developed guidance on the publication of clinical data using a redaction method (an anonymization technique). Redaction is the process of editing text for publication of clinical trial data in drug submissions and medical device applications publicly available for non-commercial purposes, following the completion of the Regulatory review process.

AXSource can support your organization with
• the procedures to prepare information for release; and
• classifying information subject to the definition of Confidential Business Information (CBI)/ Commercially Confidential Information (CCI) and protection of personal information

A Proactive Approach

Sponsors are now seeking a more proactive approach for ensuring compliance. Since implementing in-house QA teams can be expensive, the use of third-party auditors in a targeted approach is an excellent option. Using AXSource consultants that are well versed in clinical research and have expertise in regulatory affairs and quality compliance, is the best approach. Having supported numerous companies in GCP, GLP, GMP, GDP and Pharmacovigilance, we know what inspectors look for and support the implementation of GxP framework, gap analyses and support customized training initiatives.