Clinical Research & Compliance Consulting (CRCC)

CRCC (Clinical Research & Compliance Consulting, LLC) provides independent consultation leadership to medical device and pharmaceutical organizations on clinical research, regulatory strategy and compliance as well as executing strategic plans to achieve FDA and global approvals for product market releases.

Clinical Research Organization Leadership – CRCC has deep and broad experience serving in a consultant or interim leadership role for medical device sponsors, hospitals, universities and institutes
Driving Clinical Operations Excellence – with focus on each aspect of clinical trial planning and management
Ensuring Clinical Compliance – through assessment and evaluation for regulatory compliance

Services:
• Interim Executive Leader
• Clinical strategy and protocol development
• Project management
• Investigator and coordinator meeting
• Site Qualification & Selection, Initiation, Training and Management
• Clinical Monitoring and management
• CRO, Core Lab and vendor management
• Data Management
• Clinical Safety (DSMB & CEC)
• Prepare and manage site and sponsor audits, anticipate and mitigate barriers. FDA and notified body audits including preparation, conduction, and follow-up documentation.
• Certified auditor – conducts sponsor, clinical site and CRO, Core Lab, vendor, IRB and research laboratory audits
• Develop and implement global policies, procedures and tools
• Report writing
• Presentations: Investigators, sites, conferences, senior leadership and board meetings

Therapeutic trial specialities include Cardiology / Cardiovascular, Diabetes, Gastroenterology, Gynecology, Metabolic, Nephrology, Neurology, Obesity, Oncology, Orthopedics, Pain, Pulmonary / Respiratory, Transplant, Urology, Vascular, Wound Healing for Adult / Pediatrics / Geriatrics

Contact Jan Dugas to learn how we can help your organization achieve clinical success at [email protected] or visit dugasclinicalresearch.com

Company’s Keywords:

clinical compliance, clinical research, audits, interim executive leader