PPD 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.
PPD has 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
Rose Blackburne, MD, MBA is Vice President and Global Head of Women’s Health/General Medicine at PPD, a part of Thermo Fisher Scientific
Rose Blackburne, MD, MBA is Vice President and Global Head of Women’s Health/General Medicine at PPD, a part of Thermo Fisher Scientific. Based in the Washington, DC area, Dr. Blackburne is board certified in Obstetrics/Gynecology with over 25 years of experience in Health Care, including 17 years in clinical research. Dr. Blackburne is a globally recognized leader in product development and has been instrumental in numerous approvals for pharmaceuticals, vaccines, medical devices and diagnostic tests. Since 2016, Dr. Blackburne has served as Industry Representative Alternate to the FDA Patient Engagement Advisory Committee (PEAC) part of FDA’s Patient Focused Drug Development initiatives, to provide advice on issues relating to the regulation of medical devices and their use by patients, and to develop Agency guidance and policies.
Karin Coyne, PhD, MPH, vice president, patient centered research
Dr. Karin Coyne has been developing and validating patient reported outcome measures in Urology for over 20 years with over 60 publications in Journal of Urology, European Urology, British Journal of Urology International, Journal of Sexual Medicine, Quality of Life Research, and Value in Health. She has extensive experience in qualitative and quantitative methodologies and expertise in regulatory strategy regarding the inclusion of clinical outcome assessments as primary or secondary endpoints in urologic clinical trials.
Coyne also chairs the National Institute of Health (NIH) external expert panel for prevention in lower urinary tract symptoms (PLUS) network and is a member of the external expert panel for NIH’s lower urinary research network (LURN).