Auditing

Our main aim is to assure that Human Subjects are protected while achieving Safety and Efficacy Objectives of clinical trials. We accomplish this through Quality Audits with system approach that focus on proactively identifying the risks and non-compliance that compromise patient safety and product efficacy.

Whether auditing against your Protocols or Standard Operating Procedures, Industry Standards or Regulatory Laws, we independently assess your compliance level while also providing valuable recommendations for improvement.

We provide following main types of audits:

• Investigator site audits
• Assessment audit of vendors
• System audits

Consulting

Our independent expertise combined with huge experience in clinical trials allows us to provide project-based and advisement services to assist you in achieving your goals while conducting clinical trials in Russia and Ukraine.

We provide following consulting activities in Russia and Ukraine:

• SOP Development
• Mentoring and support

Training

We provide training to ensure that clinical trials are performed to high ethical and quality standards.

Preparation for regulatory inspections

We may help to prepare Investigational sites to different kinds of regulatory inspections (FDA, EMEA, Russian and Ukrainian authorities).

Audits support

We may provide independent translation and audit logistics support to our Client’s auditors traveling to Russia and Ukraine.