Clinical Monitoring
Clinical monitoring services are a crucial component of clinical trials, ensuring data integrity, patient safety, and regulatory compliance. IDDCR provide a wide range of clinical monitoring services to support pharmaceutical and biotech companies.
On-site Monitoring
Site Visits: Regular visits to clinical trial sites to oversee study conduct, data collection, and adherence to protocols.
Source Data Verification: Checking the accuracy and completeness of source documents against the case report forms.
Investigator Meetings: Conducting meetings with investigators to discuss study progress, address issues, and ensure compliance.
Off-site Monitoring
Remote Monitoring: Utilizing technology to monitor study progress, review data, and communicate with sites from a remote location.
Risk-Based Monitoring: Employing statistical and risk assessment tools to prioritize monitoring activities based on identified risks.
Centralized Monitoring: Centralizing data collection and review processes to enhance efficiency and consistency.
Safety Monitoring
Adverse Event Monitoring: Tracking and reporting adverse events to regulatory authorities and sponsors.
Safety Data Review: Analyzing safety data to identify potential safety signals and take appropriate actions.
Safety Reporting: Preparing and submitting safety reports to regulatory agencies.
Quality Assurance
Quality Control: Ensuring adherence to quality standards and guidelines throughout the trial.
Audits: Conducting internal and external audits to assess compliance and identify areas for improvement.
Corrective and Preventive Actions (CAPAs): Implementing measures to address identified deficiencies and prevent future issues.
Regulatory Compliance
Regulatory Submissions: Assisting with the preparation and submission of regulatory documents.
Regulatory Compliance Oversight: Ensuring compliance with applicable regulations and guidelines.
Regulatory Interactions: Interacting with regulatory authorities on behalf of the sponsor.