Modoc Clinical Monitors (CMs) are regionally based in the corridors of many major clinical research centers and academic sites. Each Modoc CM has significant clinical monitoring experience and takes part in ongoing training in GCP, trial management and regulatory topics. The level of experience and training required of Modoc CMs provides our client sponsors the confidence that their studies will be conducted in accordance with all applicable FDA regulations and ICH/GCP guidelines to ensure optimal and accurate study outcomes. Our CMs establish a professional relationship with their sites to enhance effective interaction and communication. A well-executed study depends on proactive on-site and in-house monitoring conducted at the appropriate frequency. The goal of each monitoring visit is to ensure compliance with the protocol and to confirm that clinical data captured is accurate and of the highest quality.

What our CMs do…

Pre-Study/Qualification Visits

• Modoc CMs conduct comprehensive assessments of the investigator’s training and history of study oversight, staff training and capabilities, subject population, physical facilities of each proposed clinical research site.
• The ability of the site staff to adhere to GCP, ICH guidelines and FDA regulations is critically reviewed.

Initiation Visits

• Modoc CMs conduct thorough site initiations, providing the investigator and site staff with:
  • A comprehensive review of protocol and all study-related documentation, subject recruitment and accrual goals and schedule of study-related assessments and procedures
  • Review of the required regulatory documents as well as ongoing regulatory-based processes
  • Training in case report form (CRF) completion (electronic or paper)
  • Guidelines for proper handling, storage and administration of investigational product(s)
  • Review of site and investigator responsibilities for the conduct of the clinical trial

Interim Monitoring Visits

• Modoc CMs conduct utilize both in-house and on-site monitoring to ensure that the study progress meets the expectations of the client sponsor and that study conduct is appropriate and within all applicable guidelines
  • In-house monitoring through site communication and ongoing review of completed CRFs, if electronically submitted
  • Utilization of flexible visit schedules based on subject accrual and data quality
  • Proactive assessment of site performance
  • Effective communication with investigator(s) on study progress

Close-Out Visits

• Modoc CMs manage time on site to assure that the final close-out visit can be performed swiftly and completely
  • Coordinates confirms final resolution of all data queries
  • Final review of regulatory documentation
  • Assurance that all site regulatory obligations are complete
  • Final investigational product accountability
  • Return of any and all remaining investigational product from site
  • Review of publications plans for study results with investigator
  • Wrap up of final study obligations

Query Management

• Effective site management and accurate monitoring resulting in lower query rates and higher data quality
• Ongoing query management enables access to precise data during critical times in the drug development decision process