“Practical Clinical enabled our small start up company to make a paradigm shift into the clinical development phase. They represented Otonomy’s best interests while managing the clinical CRO with regards to all aspects of clinical study operations; project management, site initiation, monitoring, biostats, data management, IWRS, drug distribution vendors, clinical advertising safety and medical monitoring. For example, PC’s expertise in clinical development increased our team’s efficiency with regards to start up activities including detailed reviews of protocol, informed consent, functional study plans, and DSMB charter.”

“Practical Clinical have assisted in many aspects of trial management and logistics including negotiating with CROs, and study start up activities, recruitment, budgeting, document review, etc, etc. We have found Practical Clinical to be an excellent, efficient, effective and pro-active team of highly skilled individuals. Our experiences have been very positive and our objectives have been achieved. Highly recommend Practical Clinical.”

“There are very few companies we’ve worked with in the past that have brought such insight and strong direction to what is otherwise a challenging and complex set of processes. What a team! You’ve been so valuable to work with through the years. It is always a pleasure seeing how easily you seem to steer around what are often hurdles. That’s experience and that’s what is so valuable! Working with the Practical Clinical team always reminds me that there’s a way to reach our goals. You help us get there.”

“I have worked with Leslie, Lisa and Kris for over a decade and consider their knowledge of global clinical research operations to be unparalleled in the industry. They are my go to experts for clinical research strategy, operational planning and study execution input”

“It has been our pleasure to have worked with Lisa Guttman and Leslie Guerreiro on a number of trials in recent years. The obvious expertise demonstrated by their clinical team has meant that relationships run more smoothly and potential challenges are identified early on, long before problems arise. We look forward to working with Practical Clinical again and again in the near future.”

"Practical Clinical was engaged to assist in a major overhaul of Clinical Affairs SOPs for a clinical lab, clinical operations, and data management. The team has extensive knowledge of FDA, GCP, and international regulations for medical device development. Our timeline for project completion was very tight: five months from start to finish. Nonetheless, it was accomplished on time, with no delays!! I cannot say enough of how a project that I was not looking forward to was made incredibly easy and enjoyable. I cannot wait to work with them again!"