MONITORING & Auditing PROGRAM DEVELOPMENT SERVICES
Clinical Pathways has helped sponsors and CROs develop monitoring, auditing, and oversight programs. This includes onsite and remote monitoring process that blend systems and skill to ensure an effective risk-based approach. Clinical Pathways has developed full curriculum training programs for monitoring that is competency based. CP has trained 100’s of monitors and study coordinators over the last 20 years. Our program development is based on 50+ years of past and current experience in the medical and clinical research industries.
We believe that meeting (or better yet beating) timelines and critical milestones hinges on superior clinical monitors who are highly experienced, efficient, and easy to work with. Clinical Pathways, LLC also believes that quality control and assurance with a foundation of critical thinking are key to ensuring human subject protections and improving performance.
With more than 35 years of industry and professional nursing experience each, our small team of highly-trained consultants are experts at monitoring, assessing monitoring performance, auditing, and CRO oversight. Our monitors have maintained ACRP certifications for a minimum of 14 years and are volunteers who commonly speak at industry conferences and/or serve on committees. The following are their specialties:
Phase I, II, IIIA and IIIB and Phase IV Post-Marketing studies for pharmaceuticals and biologics
Significant/non-significant risk IDE studies for medical devices
Pre-Study, initiation, interim monitoring and close-out visits- including tool and training method development to support teams for maximum performance and efficiency
Pediatric and adult studies
Pharmaceutical, biological, medical devices / industry sponsored and investigator-initiated
Facilitation/conflict resolution between sites and sponsors/CROs
Remote and centralized risk-based monitoring plans
Audit preparation
Root cause analysis and corrective/preventive action plan development and facilitation
Broad spectrum of therapeutic areas in pharmaceutical, biologic and medical device studies that include but are not limited to: neurology/psychiatry, respiratory, women’s health, oncology, infectious disease, virology, autoimmune disease, pain, cardiology, dermatology, GI and orthopedics
Multiple electronic data capture systems and a variety of CTMS products
Report review and report writing training
Site compliance, TMF, and data management auditing