Clinical Monitoring – It's all about the data...

Effective Clinical Monitoring is a key component to ensuring high-quality data from your Investigators to support your product's claims of efficacy and safety.

ClinOps prides itself on having the type of flexibility you require and are pleased to work with you to provide the best solution for you and your study. A few examples include:

• Regional Approach – CRAs assigned in close proximity to your sites
• Fully Dedicated Approach – Smaller number of CRAs who focus strictly on your study

Because we have all experienced untimely turnover of CRAs on our projects due to either promotions or just the competitive nature of the business, ClinOps deploys the strategy of utilizing a blended approach of employees and very seasoned independent CRA contractors. This also helps to keep our overhead costs down which in turn means lower costs for you.

The primary goals of clinical monitoring are to ensure that investigators and their staff are:

• Appropriately selected
• Continually trained to complete the proposed protocol-driven research
• Provide accurate data
• Able to observe proper patient protection standards
• Proactively informed of data collection milestones to ensure you are well prepared for interim analyses, scientific meetings, go no/go decision time points and database locks

Training that Focuses on Your Trial

All of our CRAs receive on-going training. Because experience within the therapeutic area helps ensure a more efficient and effective trial, we ensure our CRAs have received clinical monitoring training in specific diseases as well as a strong track record for monitoring those particular trials.