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.
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