PEDIATRIC
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PSI RECENTLY CONDUCTED THE LARGEST INDUSTRY-SPONSORED SAPs PROGRAM IN
Pediatric Oncology – Phase III
Approved
www.psi-cro.com
500+ patients with chemotherapy-induced nausea and vomiting (aged 0 to 16 years) Challenges: Regulatory questions/prolonged approval timelines Enrolling diverse population (various racial/ethnic backgrounds) PK sub-study Study completed on time with 103% of target patient population recruited across 81 sites in Europe, Russia, North America and Latin America
Pediatric Clinical Trials
Hemophilia B â&#x20AC;&#x201C; Phase IV Severe (FIX level < 1%) or moderately severe (FIX level = 2%) Hemophilia B (>0 years) " Study design: Prospective, Open-Label $%&'8$)9)-"8$-.%")0" 6 countries/13 sites Enrollment period: 21 months, completed on time :;"
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Study Filings with Competent Authorities: On-Time
Sites Enrollment Ready: On-Time
Hepatitis B â&#x20AC;&#x201C; Phase III Population: Chronic Hepatitis B in adolescents Study design: double blinded efficacy/antiviral vs. placebo " 13 sites $%8-1)1)."<"8$-.%")))" Enrollment completed 2 months ahead of schedule 63"
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Post-Operative Nausea & Vomiting Population: Newborn to 17 years Study design: open label 42 sites in US, Europe and Latin America " Enrollment period of 9 months, completed 3 months 8'.1('8%P-1)0%"*-,.%-"/"0'&)1)*2"8$-.%")))" ahead of schedule ==3"
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Safety Database Set-up: On-Time
Final Statistical Analysis: Ahead of Schedule
OUR EXPERTISE in Pediatric Indications PSI brings a wide-ranging depth of expertise to the conduct of studies in Pediatric populations. PSI has completed numerous such trials in a variety of indications, across all pediatric age groups and world geographies. We include our pediatricians, who focus primarily on pediatric programs, in both our operational and medical teams. PSI has in-depth expertise with the inherent challenges that need to be addressed in the planning stages for conducting successful Pediatric Trials: • Regulatory Specifics for Pediatric Indications with country references • Working knowledge of the Pediatric Research Equity Act (PREA) Guidelines • Working knowledge and with Partners in Pediatrics (PiP) Guidelines • Varying consenting approaches in different parts of the world • Enrollment Methodologies • Working with Parents and Patient Advocate Groups PSI’S PEDIATRIC FACTS: • 91% of PSI’s Pediatric studies meet or beat projected timelines • 16 pediatricians on board • 50% of PSI Project Managers have Pediatric trial experience • 40% of PSI Clinical Research Associates have Pediatric trial experience • Multiple FDA Inspections resulting in Drug Approvals for the following indications: • Chemo-Induced Nausea & Vomiting • Recurrent Cold Sores • Diabetes Mellitus Type 2 • Hemophilia B
Last Patient In: Ahead of schedule
Last Patient Out: Ahead of schedule
Support personnel for any pediatric study at PSI include Medical Monitors, Statisticians, Regulatory Officers, Data Managers, Logistical Experts and Quality Assurance. With a staff turnover rate of <5 %, chances are good that noted team members have worked on a large number of pediatric studies at PSI. This experience enables PSI to use not only historical data but informs our knowledge of current practices. We apply our understanding to prepare for and overcome key challenges during the regulatory process and approval for all pediatric studies.
PSI HAS THE FOLLOWING PHASE II-IV EXPERIENCE IN VARIOUS PEDIATRIC DISEASE TYPES THAT INCLUDES: Acute Hematogenous
Herpes Simplex Labialis
Osteomyelitis
Hypertension
Allergic Rhinitis
Hemophilia A
Asthma
Hemophilia B
Cancer Pain
Hunter Syndrome
Primary Cataract Extraction
Leber Congenital Amaurosis
Chemo Induced Nausea & Vomiting
Multiple Sclerosis
Chemo Induced Neutropenia
Pediatric Osteoporosis
Chronic Hepatitis B
Post-Operative Nausea & Vomiting
Congenital Heart Disease Community Acquired Bacterial Pneumonia
Respiratory Syncytial Virus (RSV)
Ewing Family of Tumors or Rhabdomyosarcoma
Solid Tumors
First Patient In: On-Time
Short Bowel Syndrome Type II Diabetes Mellitus
Last Patient In: Ahead of schedule
The geographical span for our Pediatric Disease experience
RESPIRATORY SYNCYTIAL VIRUS (RSV) REGULATORY CONSULTANCY FEASIBILITY STUDY PEDIATRIC OSTEOPOROSIS CHEMO INDUCED NAUSEA & VOMITING CREATE CRF SET UP STUDY DATABASE STATS ANALYSIS PLAN SITE SELECTION SET UP STUDY LOGISTICS STUDY FILING WITH COMPETENT AUTHORITIES
AHEAD ON TIME ON TIME AHEAD ON TIME AHEAD AHEAD ON TIME ON TIME ON TIME ON TIME
Pediatric Feasibility Studies Map – Past 3 Years
First Patient In: On-Time
Last Patient In: Ahead of schedule
ON TIME SITE CONTRACTS ON TIME HEMOPHILIA A & B AHEAD HUNTER SYNDROME ON TIME SITES ENROLLMENT READY AHEAD CHRONIC HEPATITIS B ON TIME FIRST PATIENT IN COMMUNITY ACQUIRED BACTERIAL PNEUMONIA ON TIME AHEAD HERPES SIMPLEX LABIALIS AHEAD LAST PATIENT IN AHEAD LAST PATIENT OUT ON TIME HYPERTENSION AHEAD LOCK DATABASE ON TIME FINALIZE INTEGRATED REPORT
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FEASIBILITY PSI is an expert at conducting regional or global feasibility that provides the best choice of sites and geography with accurate recruitment forecasts. Every project that PSI undertakes is given a thorough assessment by dedicated full-time feasibility staff. For pediatric programs these dedicated professionals determine clinical trial study feasibility for each of the following criteria • Medical Feasibility • Clinical Feasibility • Regulatory Feasibility • Laboratory Feasibility • Logistical Feasibility In recent years, our specialists located in 11 countries of North America, Europe, Asia and Latin America have conducted hundreds of feasibility assessments for Pediatric Disease programs in 50+ countries, including rare indications. These assessments cover, but are not restricted to, evaluation of the target population availability and factors that limit it, standards of care, competitive studies, regulatory climates and the need to engage particular Key Opinion Leaders into the study. We weigh all of these factors before making recommendations on the best choice of sites and geography for your program. More than 91% of our pediatric studies are finished on or ahead of schedule.
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I CLIN Feasibility Completed: Ahead of schedule
Protocol Completed: On-Time
ACCOUNTABILITY PSI’s reputation is that of a no-nonsense CRO that delivers by taking the right actions even when that is the harder path. However well one plans a study, the unexpected will happen. What differentiates a good vendor from everyone else is the manner in which difficulties are managed. At PSI, studies enroll on time not only because they are well-planned, but also because the project teams assume an attitude of “get it done or die trying”. Most of the projects we undertake are “tough”. PSI has won many unwinnable battles by sheer persistence in an effort to keep our promises to our clients. To us, doing the right thing means: • We do our best to keep your expectations in line with reality because we are accountable for every promise we make. • We speak our truth even if it is not what you expect to hear. We wish to guide you on the right path, not let you believe something just because it is what you want to hear. • We show you how we can meet your study timelines by telling you which countries can enroll and how to realistically integrate the contributions of strategically important regions and KOLs.
Comprehensive Project Plan: On-Time
Database Lock: Ahead of Schedule
THE PSI STORY PSI’s strength is in its people and their attitude. The PSI management team that founded the company 19 years ago is still here and fully engaged in day-to-day project life. “Navy seals of the CRO industry” was how one of our clients described PSI. In our industry more than 90% of clinical trials fall behind deadlines, while 95% of PSI studies finish on time or ahead of schedule. We subscribe to the belief that “it’s kind of fun to do the impossible”. We maintain our practice of investing in talent because we know that only devoted and accountable people can deliver the kind of service that will ensure outstanding results for our clients. Our mission is to be the best CRO in the world as measured by our clients and our employees. With 1,400+ folks in 50+ countries we have a lot of talent to look after. Dozens of customers in a variety of therapeutic areas have come to PSI and stayed. Maybe that is why after 19 years in the industry PSI still enjoys a solid reputation and grows mainly through repeat and referral business. When combined, these characteristics yield tangible outcomes for our customers. Studies run on time and on budget and save hundreds of millions of development dollars.
On-Time Enrollment
250 Physicians On-Board
On-Time Project Delivery
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