MOnitoring & Auditing
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 believe that Quality Assurance is key to ensuring human subject protections and improving performance.
All of our Clinical Monitors (CRAs) have Baccalaureate Degrees in Nursing, and have 10-15 years of monitoring/auditing experience in the industry. They are all certified clinical research professionals and volunteer in the industry speaking at industry conferences and/or serving on committees. They specialize in the following:
- 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
GCP Training Services
We partner with clients to produce effective quality training for a variety of audiences within the global clinical research industry: Sponsors, CROs, Research Sites, IRBs and more.
Our officers are certified clinical research professionals with degrees in nursing and education with over 30 years of training development and presentation experience for medical device, pharmaceutical and biologic research. Clinical Pathways, LLC produces timely, on point, effective and respected trainings no matter the length or topic.
Clinical Pathways, LLC builds within every presentation and curriculum:
- Support of performance improvement
- Clinical quality promotion
- and critical thinking skills.
Training Services include but not limited to:
- Training for Clinical Operations Research Professionals:
- Monitoring, Data Management, Safety, Support Services, Quality, Compliance
- Training Gap Analysis
- Credentialing Strategy and Facilitation to Support Quality System
- Core Curriculum Development and Maintenance
- Facilitate LMS Certifications for Functional Area Layers
- Varied Training Approaches to Meet the Needs of a Mobile Work Force
- e-Learning Development and Deployment: SCORM for LMS or non-LMS eLearning Solutions. CLICK FOR SAMPLE
- Web-seminars, Live and Recorded
- In-person Training: Small to Large Audience
- Workshops and Conferences
- Reinforcement and Advanced Training
- Design Training to Support Various Cognitive Levels and Testing
- Facilitate Training Accreditation and Maintenance
Clinical Quality SystemS
The clinical research industry is going through a clinical quality revolution to increase subject safety, data integrity, speed to access more and better treatments, while also promoting working smarter to support project cost containments and affordability of to the patient. This is a time of great change in clinical investigation oversight of self and those you rely on to conduct responsibilities and/or studies that requires stakeholders to have effective clinical quality systems to support this balance between safety, cost, timeliness, compliance and more. This affects processes, procedures, job descriptions, organizational structure, training, vendor management, budget and contract negotiations, quality focus, talent acquisition, and more.
Even before this shift, Clinical Pathways has always had a goal for our consulting projects to promote better clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. This can be done by developing new or revising existing policies, procedures, training materials and programs to meet current and new industry regulations, including implementation planning/strategy.
QUALITY RISK MANAGEMENT & PERFORMANCE IMPROVEMENT FACILITATION
We believe providing a service/product that does not support or promote quality usually does not benefit any stakeholder and does not yield a positive return on your investment. Whether the project focus is a proactive process to prevent issues and minimize risk, or a reactive process to ensure effective issues escalation and compliance management, we work with clients to establish quality system development to promote continuous improvement. A few examples of services we offer clients related to promoting clinical quality systems and continuous improvement:
- Plan, conduct and/or facilitate a systems gap and impact analysis related to new requirements or goals, e.g., clinical quality risk management integration in to GCP.
- Develop/ adapt risk assessment models and tools to map to centralized data monitoring analytics for clinical quality risk management.
- Facilitate and develop compliance management processes for clinical investigation oversight to promote performance improvement and essential documentation.