PharmaPhase Management, LLC

Clinical Trial Management & Monitoring-Specialty CRO. All PPM clinical trial professionals have extensive clinical development experience with all phases of clinical trials. The PPM team has CRO as well as Pharmaceutical clinical trial management/monitoring expertise offering clients first-hand knowledge, understanding, and appreciation of study completion from both perspectives. PPM provides its pharmaceutical, bioscience/biotechnology, and/or academic clients with: Study Start Up -- including facilitating protocol development, site recruitment and feasibility studies, essential document collection & processing, and negotiation & review of study budgets and research agreements; Clinical Monitoring -- including clinical site monitoring-both eCRF & paper CRF and site compliance with Good Clinical Practices; Project Management -- including customized communications, monitoring, regulatory, safety, and master documents development, customized study status tracking, investigator meetings, and vendor partner management; Consulting Services -- including study file set-up, SOP development, Business Practice development, Job Description development, organization of external consultant meetings as well as Transition/Rescue Planning and Management. Multi-Disciplinary Partnerships (MDPs) PPM’s unique MDP Model affords its clients the availability of services in only the areas of expertise desired…without the burden of managing multiple vendors. ~ Vendor/Partner Services Management ~ Available Partner Services include: * CMC * Regulatory * Medical Writing * Biostatistics * Data Management Specialties: Some areas of experience have included (but are not limited to) Cardiology/Cardiovascular, CNS/Neurology, Dermatology/Wound, Endocrinology, Gastroenterology, Infectious Disease, Oncology, Pediatrics, Pulmonary, Rheumatology, Supportive Care Therapy, Pain, Urology, Vaccine, and Women's Health.