Indivirtus independent quality assurance (QA) team identify/mitigate potential problems at the early stage, so we can take corrective and preventative action well in time.
We prioritize integrating QA team within each clinical trial step right from the start to ensure all trials fully align with Good Clinical Practices (GCP), ensuring participant safety and well-being while maintaining data quality/integrity.
Our QA team also ensure that our clinical development services are aligned with International Conference on Harmonization (ICH) GCP guidelines and relevant laws and international regulatory authority expectations, with support on the following practices:
Clinical Research: We ensure compliance with protocol, SOP, and regulatory guidelines with emphasis on subject safety and data quality/integrity. Our services extend to reviewing critical documents such as CSRs and TMFs, ensuring accuracy and compliance.
Risk Management: Striving to stay ahead of potential challenges, we dive into risk assessments, categorization, proactive mitigation strategy, and ongoing risk monitoring to keep client projects on track throughout the clinical development journey.
Standard Operating Procedure (SOP): We design/develop SOPs and procedures aligned with regulations and industry best practices and are fully customizable per specific trial requirements.
Inspection-Readiness Support: Comprehensive inspection preparation, attendance, post-inspection follow-up, and corrective action support is one of our core strength to ensure robust compliance.
Vendor Management: Vendor-qualification audits, vendor oversight, and performance-monitoring activities alongside vendor-compliance checks are among the regular activities.
Audits: Our audits range from investigator site and vendor audits to process/system and GMP/GLP audits, ensuring that client operations rise to the highest standards.
Quality Assurance (QA) and Monitoring Services in clinical research are essential components of ensuring that clinical trials are conducted in accordance with regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines. These services help guarantee the integrity of clinical trial data, the safety of trial participants, and the credibility of study results.
Our Quality Assurance and Monitoring Services in Clinical Research Include:
Quality Assurance (QA) Services:
QA involves systematic and independent checks to ensure that clinical trials are planned, conducted, monitored, and reported in compliance with regulatory guidelines, protocols, and standard operating procedures (SOPs).
Key Services:
SOP Development and Review:
- Creating and maintaining SOPs to standardize clinical trial processes across sites and ensuring adherence to GCP, regulatory requirements, and company policies.
Quality Audits:
Conducting regular internal and external audits of trial sites, vendors, laboratories, and data to identify potential areas of non-compliance. This includes:
- Site Audits: Evaluating compliance with the study protocol, data accuracy, and GCP adherence.
- Vendor Audits: Auditing contract research organizations (CROs), laboratories, and other third-party vendors for compliance with regulations.
- Trial Master File (TMF) Audits: Reviewing clinical trial documentation to ensure completeness and accuracy.
- System Audits: Checking IT systems (e.g., electronic data capture systems) for security, data integrity, and regulatory compliance.
Pre-Inspection and Mock Regulatory Audits:
- Conducting mock audits and pre-inspections to prepare for regulatory inspections (e.g., FDA, EMA, MHRA) and ensure the trial is ready for submission.
Corrective and Preventive Actions (CAPA):
- Implementing CAPA programs to address any issues identified during audits, ensuring timely resolution of deficiencies and preventing future occurrences.
Training and Certification:
- Providing GCP, protocol, and regulatory compliance training for study teams, investigators, and clinical research staff to ensure they are equipped to maintain trial quality.
Process Improvement:
- Continuous assessment of clinical trial processes to identify opportunities for improvement and increase efficiency without compromising quality.
Clinical Monitoring Services:
Clinical monitoring involves the oversight of ongoing clinical trials to ensure adherence to the study protocol, GCP, and regulatory requirements, with a focus on participant safety and data integrity.
Key Clinical Monitoring Services:
Site Initiation Visits (SIV):
- Conducting initial site visits to ensure trial sites are prepared, staff are trained, and all necessary documents (e.g., informed consent forms, study protocols) are in place.
Ongoing Site Monitoring:
- Regular on-site or remote visits by Clinical Research Associates (CRAs) to monitor patient enrollment, ensure protocol adherence, verify source data, and review trial documentation, including:
1.Source Data Verification (SDV): Ensuring that the data recorded in the case report forms (CRFs) matches the original medical records.
2.Data Integrity and Accuracy Checks: Identifying and resolving discrepancies in the data collected from clinical trial sites.
Patient Safety Monitoring:
- Verifying that patient safety measures, including informed consent processes, are properly conducted and documented, and reviewing adverse event (AE) and serious adverse event (SAE) reports for accuracy.
Risk-Based Monitoring (RBM):
- Using a targeted, data-driven approach to prioritize monitoring efforts based on identified risks, focusing resources on high-risk areas, and reducing unnecessary site visits.
Remote Monitoring:
- Conducting monitoring activities remotely through centralized systems, allowing CRAs to review site data and address issues without physical site visits, especially useful during pandemics or in geographically dispersed trials.
Close-Out Visits:
- Ensuring all trial documentation is complete, all data is captured and verified, and all issues are resolved at the end of the trial before regulatory submission.
Regulatory Compliance:
Ensuring that clinical trials adhere to all relevant regulatory requirements (e.g., FDA, EMA, ICH-GCP, local ethics committees) and preparing for regulatory inspections.
Regulatory Submissions Support:
- Providing support in the submission of documents (e.g., Investigational New Drug (IND) applications, Investigational Medicinal Product Dossier (IMPD)) and ensuring all regulatory requirements are met.
Regulatory Inspection Readiness:
- Preparing clinical trial sites for regulatory inspections, ensuring that all documentation, trial processes, and staff are prepared to meet regulatory scrutiny.
Post-Inspection Support:
- Managing follow-up activities after a regulatory inspection, including responding to inspection findings and implementing CAPAs.
Data Quality and Integrity Assurance:
Ensuring the reliability, accuracy, and integrity of clinical trial data through real-time monitoring and verification processes.
Ethics and Informed Consent:
Monitoring compliance with ethical standards, particularly regarding informed consent procedures, participant rights, and ethical review approvals.
Informed Consent Process Monitoring:
- Ensuring that informed consent is properly obtained and documented from all study participants, and that participants are fully informed of their rights and the trial details.
Ethics Committee/Institutional Review Board (IRB) Compliance:
- Ensuring that all trials have ethical approval, and that any amendments or updates to protocols are reviewed and approved by relevant ethics committees.
Risk Management and Mitigation:
Identifying and managing risks that could impact the quality or success of the clinical trial.
Patient Safety and Pharmacovigilance Integration:
Ensuring that all adverse events and safety concerns are reported and managed according to regulatory requirements and pharmacovigilance practices.
Adverse Event (AE) Monitoring:
- Tracking and reporting AEs, SAEs, and suspected unexpected serious adverse reactions (SUSARs) to the relevant regulatory authorities and ethics committees.
Safety Data Review and Reporting:
- Regularly reviewing safety data to identify trends and potential safety signals, ensuring timely and accurate reporting to regulatory agencies.
Benefits of QA and Monitoring Services:
Regulatory Compliance: Ensures that trials are conducted in line with global regulatory requirements, minimizing the risk of non-compliance or delays in approval.
Data Integrity: Helps maintain the accuracy, consistency, and reliability of clinical data, which is critical for regulatory submissions.
Patient Safety: Ensures that patient safety is a top priority by monitoring adherence to protocols, informed consent processes, and safety reporting.
Trial Success: Early identification of issues reduces the risk of trial delays or failures, ensuring that studies proceed as planned and meet their endpoints.
These services are vital for maintaining the credibility of clinical research and ensuring that clinical trials produce reliable and valid results for regulatory submissions and subsequent drug approvals.