Multiple Sclerosis Phase II & III Clinical Trials

Consistent on-time and on-budget delivery on dozens of MS trials, current contact templates with hundreds of institutions, expert knowledge of specifics of running placebo-controlled MS trials around the world, and more…

Excellent relationships and MSAs with productive sites around the world.
FDA and EMA inspections of PSI's MS sites resulting in drug approval.

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.

Patient Populations

  • Relapse-Remitting Multiple Sclerosis (RRMS)
  • Secondary Progressive Multiple Sclerosis (SPMS)
  • Relapsing Multiple Sclerosis (RMS)
  • Adult and pediatric populations

Experience in

  • Active-controlled & placebo-controlled designs
  • Bioequivalent trials
  • Programs of several studies

MS Agents

DMDs

  • Interferons
  • Glatiramer acetate
  • Monoclonal antibodies
  • Immunomodulating drugs
  • IV immunoglobulins

Symptomatic treatment

  • Spasticity

MS is a competitive indication and good sites have ample choices about which studies to put patients on and which to keep on a back-burner.

Research shows that how sites perceive CROs influences how they perceive the sponsor. According to the global bi-annual investigator survey run by CenterWatch, PSI was voted number 1 CRO in the majority of categories in both 2015 and 2017. Heavy investment into site relations and management is a function of successful patient enrollment that PSI sees across MS sites around the world.

PSI’s key differentiator is our ability to plan and execute complex clinical trials on time, saving our customers millions of development dollars.

Patient Engagement

PSI’s strength is in its people and their attitude. The PSI management team that founded the company 20+ 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 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 2,200+ folks in 60+ 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 25+ 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.

“PSI is an excellent company. These people know their clients and their resources, anticipate problems and propose solutions before you even realize you need them.”

Client CEO

The PSI Advantage

PSI CRO has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is also the fourth year in a row in which PSI CRO received CRO Leadership Awards in all five categories, also including Expertise and Capabilities. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

Therapeutic areas

Inflammatory Bowel Diseases (IBD)

Crohns’ Disease, Ulcerative Colitis and other IBDs.

Oncology

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer and other Oncology indications.

Hematology

Multiple Myeloma, Lymphomas, Leukemias and other oncohematological indications.

Infectious Diseases

Antimicrobial and Antifungal infections and other ID.

Multiple Sclerosis

Multiple Sclerosis, Spasticity and other neurological indications.

Rare Diseases

Hemophilia A & B, Von Willebrand Disease, Thrombocytopenia, Polycythemia Vera, Paroxysmal Nocturnal Hemoglobinuria (PNH).