As international and federal regulations become increasingly stringent, the need to ensure compliance has never been more important to research program success. Quality must be built into clinical research programs and our quality experts know how to ensure compliance. In clinical research, effective quality assurance (QA) is an integral part of every quality system. From the development of policies, procedures and work instructions to the implementation of ongoing oversight programs including audits and corrective and preventive action (CAPA) plans, QA is needed to meet regulatory agency and industry-driven requirements.
With over 30 years of GxP auditing experience, our auditors are trained and ready for hire. We can conduct operational assessments, perform gap analyses, audit for compliance or help to implement quality systems. As an approved Independent Review Organization (IRO), MedTrials can also assist with compliance program planning and implementation. Let our QA experts help to ensure inspection readiness.
- GxP audits (Clinical investigator, sponsor, CRO, SMO & IRB)
- CAPA management and consulting
- Clinical database/data verification audits
- Clinical study document reviews
- Compliance consulting
- Due diligence audits
- Gap analysis
- Governance program consulting
- Mock regulatory inspections
- Performance metrics, scorecards and quality-risk indicators
- Pharmacovigilance system audits
- Quality management system (QMS) planning and implementation
- Quality agreement development
- Quality plan development
- Quality system audits
- Regulatory inspection readiness planning
- Risk management
- Standard Operating Procedure (SOP) development
- Vendor assessment/qualification
MedTrials’ clinical research services arm you with decisive support at every phase of your trial. Our trial management teams are qualified by training and experience with the requisite knowledge, skills and abilities to successfully deliver reliable data from protected subjects on time and on budget.
MedTrials’ clinical trial management services bring you:
- Experienced networks and strategic execution. We work with the finest therapeutic and regulatory experts in order to improve start-up times and guarantee efficient delivery every step of the way.
- High quality-trial execution via a dedicated and customer-oriented clinical project manager.
- An expert team that will find the right site, at the right time; keeping your specific trial needs in mind.
- Improved data quality via efficient and detail-oriented site management.
Data analytics solutions–customized based on scientific, regulatory, and client needs—are at the core of our clinical research services.
Our informatics solutions improve your drug development timelines and operational efficiency via the generation of valid, reliable, complete, and accurate information.
Among many other capabilities, MedTrials’ informatics equip you with:
- Enriched clinical data suitable for regulatory submissions and publications.
- Actionable insights via predictive analytics and real-time data analyses that streamline clinical development.
- Biometric planning and execution that promotes evidence-based solutions.