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PSI PASSES ANOTHER 9 FDA INSPECTIONS
28 July 2010
The months of June and July have been busy at PSI – nine FDA audits back-to-back. The outcome was worth the effort: none of the 9 agency inspections revealed any actionable findings.
We are proud of this accomplishment, as the quality of our work has been validated across three therapeutic areas: respiratory, infectious disease, and CNS. Once again, not only has PSI demonstrated champion enrollment in pivotal programs, the data we generated has withstood scrutiny of the highest standard.
This brings our record to a total of 37 FDA and EMEA inspections, and this is not counting an assortment of audits by local authorities worldwide -- from Peru to Romania, from Austria to Ukraine. PSI will continue to invest every bit of time, effort, and ingenuity in our winning formula: stellar patient enrollment matched by watertight quality.
Clinical Trial News
July 2010
Week 28
- PSI initiated enrollment in a phase III study of a novel biological agent in patients with Hodgkin’s lymphoma.
- PSI initiated enrollment in a phase II study of a novel biological agent in patients with relapsing-remitting multiple sclerosis.
- PSI reached an interim enrollment objective of 50 randomized patients in a phase III study of a novel antineoplastic agent in advanced pancreatic cancer.
Week 27
- PSI reached an interim enrollment milestone of 100 randomized patients in a phase III study of a novel biological agent in metastatic breast cancer.
- PSI completed the active treatment period of a phase II study of a novel immunomodulator in patients with allergic rhinitis.
- PSI launched a phase II study of a novel immunomodulator in patients with moderately severe asthma.
Week 26
- PSI completed a phase III study of a novel antipsychotic in patients with schizophrenia.
- PSI completed a phase II study of a novel antibiotic in patients with hospital-acquired pneumonia.
- PSI completed the active treatment period of a phase III study of a novel biological agent in patients with metastatic NSCLC.
Week 25
- PSI initiated enrollment in a phase III study of a novel biological agent in patients with severe hemophilia B.
- PSI reached an interim enrollment objective of 350 randomized patients in phase III study of a novel biological agent in metastatic renal cell carcinoma.
- PSI initiated enrollment in a phase II study of a novel biological agent in patients with metastatic renal cell carcinoma.