Urology

The PPD™ clinical research business of Thermo Fisher Scientific provides a best-in-class, turnkey solution that encompasses our in-house urologic therapeutic experts, key opinion leaders (KOLs), biostatistics and patient-reported outcome (PRO) experts to ensure the successful conduct of your program. Our experts have sharpened their skills through involvement in most of the Phase III OAB development programs over the past decade, and you will see their value-adding contributions in areas such as study design suggestions, eDiary recommendations, study delivery and preparations for launch. We work with clients to create a customized solution, ensuring program objectives and endpoints are met and the data and analysis challenges inherent in urologic studies are fully addressed.

We have extensive experience in planning and implementing Phase I-IV programs for urology studies across several countries and sites. 

With global experience across multiple urology indications, we have conducted trials in recent years in the following:

• Overactive bladder
• Stress urinary incontinence
• Interstitial cystitis/bladder pain syndrome
• Benign prostatic hyperplasia (BPH) / lower urinary tract symptoms (LUTS)
• Erectile dysfunction
• Premature ejaculation
• Recurrent UTI

Our global investigator network includes urologists, nephrologists, internists and obstetricians/gynecologists. Close working relationships with these investigators and sites ensure our ability to conduct a preliminary feasibility assessment quickly in order to predict enrollment and identify potential challenges for a viable protocol.

Optimal eDiary platforms

Our experts provide best-in-class advice for an optimal eDiary platform that will benefit your program to the fullest. We have focused our search in areas such as best design, training, implementation, real-time reminders, alerts, notifications, monitoring and analysis in this known problematic area. Our integrated data analytics approach encompasses the data continuum, supporting immediate remediation at the level of a single patient diary, to cross study data assessments, allowing us to pave the way for integrated summary of safety (ISS) and integrated summary of efficacy (ISE) builds. Additionally, we will apply our holistic approach to effectively mitigate placebo response. The success of our approach has been documented across multiple studies and has resulted in a reduction of placebo response of up to 22% when site personnel and subjects are properly trained.

Our team of experts