MULTIPLE SCLEROSIS
Multiple Sclerosis – Phase III Biosimilar drug Full service study A team of 40 in-house regulatory experts was assigned at PSI to manage submissions CTAs and EC submissions filed by PSI in 26 countries (200 sites) around the world; Study approvals in 20 countries obtained on or ahead of schedule; Back-and-forth communication with authorities in 7 countries 796 patients, 168 sites across 17 countries Enrollment completed 3 months ahead of schedule
Multiple Sclerosis – Phase II Monoclonal antibody 4 countries/23 sites Enrollment completed one month ahead of schedule
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STABILITY AND CONTINUITY 10 year Multiple Sclerosis Program What started as a small Phase II project, turned into a 10-year program of 4 Multiple Sclerosis studies. The program has seen 23 audits, an EMA inspection, an FDA inspection, and included a major transition of several study countries from another CRO to PSI. All four studies hit the key performance indicators, completing perfectly on schedule. This case study also demonstrates the stability and continuity of the PSI team. As the program progressed, we watched our team grow with it. The majority of the CRAs who worked on these studies are now Project Managers or Lead CRAs at PSI. !#$%&'(")*"+(,-(')".&/"0,)+,1&123" +4567"888"79:7;6<=;">?=:=@=A" +4567"888"6:BCDE"?7A5>67C">5F7;:6"" +4567"888"6:BCDE":?75:R7;:$;5SQ7">5F7;:6"
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Comprehensive Project Plan: On-Time
Database Lock: Ahead of Schedule
Patient Populations
Making the Impossible POSSIBLE
Relapsing-Remitting Multiple Sclerosis (RRMS) Secondary Progressive Multiple Sclerosis (SPMS) Primary Progressive Multiple Sclerosis (PPMS) Progressive-Relapsing Multiple Sclerosis (PRMS) Clinically isolated syndrome (CIS) Radiologically isolated syndrome (RIS) Benign Multiple Sclerosis Exacerbated disease Patients in remission
From the beginning we have differentiated ourselves by creating robust methodology to help developers of Multiple Sclerosis compounds prove the reliability and efficacy of their drug products. PSI has a strong record in Phase II and Phase III trials in Multiple Sclerosis, having worked with various types of MS therapeutics, including Beta-interferons, glatiramer acetate, immunosuppressant drugs, and monoclonal antibodies. PSI has conducted studies with very stringent inclusion/exclusion criteria, this includes identifying and enrolling patients with at least 1 or 2 gadolinium-enhancing lesion at screening MRI; patients with at least one MS relapse during treatment with disease-modifying drugs after being on that therapy for at least 6 months; treatment-naive patients in Western Europe, etc. We have also been involved in a number of MS projects with a placebo arm. PSI has an operational team consisting of members of Senior Project Management, Project Management and CRAs who have a therapeutic focus on Multiple Sclerosis. Our support group, including Medical Monitors, Statisticians, Regulatory Affairs, Data Management, Logistics Support, Imaging Specialists and Quality Assurance, have also been exposed to a number of MS trials through this prior experience.
MS Agents DMDs:
Interferons Glatiramer acetate Monoclonal antibodies Intravenous immunoglobulin S1P receptor modulators Immunomodulators
Symptomatic Therapy: Steroids Anticonvulsants
Global Map of PSI Conducted Multiple Sclerosis Trials
In the past years, we were asked to take over several MS studies from other CROs that were transitioned to PSI for various reasons including submission delays, slow enrollment, and communication problems.
First Patient In: On-Time
Last Patient In: Ahead of schedule
Last Patient Out: Ahead of schedule
First Patient In: On-Time
Last Patient In: Ahead of schedule
TICAL LOG7I.0S6.2013 1
MEDICAL
FEASIBILITY PSI is an expert at conducting regional or global feasibility that provides the best choice of sites and geography with accurate recruitment forecasts. In recent years, our specialists located in 11 countries of North America, Europe, Asia and Latin America have conducted feasibility assessments for Multiple Sclerosis studies in 50+ countries at 1000+ sites. 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.
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Feasibility Completed: Ahead of schedule
Protocol Completed: On-Time
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.
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