Andrea Ochoa

Clinical Development

6 Data Sources You Should Be Using in Your Site Selection Process

Site selection is a pivotal phase in the planning of clinical trials. The right sites ensure timely recruitment, high-quality data, and overall study success. To make informed decisions, leveraging multiple data sources is essential for maximizing opportunity and mitigating risk.  Evaluating sites from all angles   Sponsors and CROs rely on a variety of data sources…

Clinical Development

Study Start-Up: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why we…

Other

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent…