MULTIPLE SCLEROSIS
THE PSI STORY PSI’s strength is in its people and their attitude. The PSI management team that founded the company 18+ 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 18+ 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.
ACCOUNTABILITY: DOING THE RIGHT THING 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.
Feasibility Completed: Ahead of schedule
Protocol Completed: On-Time
TICAL LOG7I.0S6.2013 1
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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. In recent years, our specialists located in 11 countries of North America, Europe, Asia and Latin America have conducted feasibility assessments for Multiple Sclerosis programs 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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Comprehensive Project Plan: On-Time
Database Lock: Ahead of Schedule
Making the Impossible POSSIBLE 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, although this has presented a major challenge, all of them completed enrollment on schedule. 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.
First Patient In: On-Time
Last Patient In: Ahead of schedule
In the past three years, we have taken over two MS studies in Europe that were transitioned to PSI for various reasons including submission delays, slow enrollment, and communication problems. Both studies were completed perfectly on schedule.
Patient Populations 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
Multiple Sclerosis Agents: Steroids (e.g. Dexamethasone) Intravenous immunoglobulin’s Interferons Monoclonal antibodies Glatiramer acetate
Last Patient Out: Ahead of schedule
First Patient In: On-Time
Last Patient In: Ahead of schedule
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; Study rejected in 4 countries due to unacceptability of placebo design 796 patients, 168 sites across 17 countries Enrollment completed 3 months ahead of schedule
Multiple Sclerosis Phase III Population: treatment-na誰ve patients with Relapsing-Remitting Multiple Sclerosis Study Drug: monoclonal antibody 4 countries/23 sites Enrollment completed one month ahead of schedule
On-Time Enrollment
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Global Map of PSI Conducted Multiple Sclerosis Trials PSI currently has a database of 1,000+ MS sites.
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