Our mission involves searching for truth in human health issues through the design of high quality research studies. The integrity of research remains our highest priority, and we bring a solid statistical approach to every phase of your clinical study, including protocol development, study design, site/investigator recruitment and management, data collection/management, statistical analysis, regulatory filing, and publications.

We understand the importance of patient safety to our clients and the assurance of managing enrolled patients safely through the duration of your study. We aim to provide you with a forward-thinking approach and a coherent safety data plan. Then in collaboration with you and clinical trial sites, we ensure that you effectively capture and analyze safety data, identify data interrelationships, and proactively uncover adverse event trends.

• Safety Reporting

• Monitoring and reporting of adverse events

• Organize and manage Data and Safety Monitoring Boards (DSMBs) 

Effectively navigating the investigational and new drug, device and biologics regulatory pathways is a critical element in the successful development of your product. During each stage of development, you face regulatory issues that can potentially impact your product timelines and chance of gaining regulatory approval. We understand your challenges in clinical product and device development and provide proactive guidance to mitigate development and regulatory risk.

• Regulatory Due Diligence

• Regulatory Training

• Preparation of Regulatory Development Plans

• Perform GMP and GLP site audits

• Perform pre-approval inspection audits

• Preparation of Standard Operating Procedures

• Perform Quality Assurance audits

• Perform pre-inspection GMP audits

• Prepare companies for regulatory audits