QA & Compliance
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.
Services include:
- 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
Clinical Trial Management
MedTrials has a strong reputation as Clinical Trial Management experts. Our teams are qualified by training and experience with the required knowledge, skills, and abilities to successfully deliver reliable data from protected subjects on time and within budget.
Our Clinical Trial Management services provide you with:
- Effective site management with accelerated study start-up and risk-based approaches.
- A broad range of experience across therapeutic areas of all phases and product types, in adult and pediatric populations.
- Integrated technology solutions for sponsor advantage.
- Reliability and expertise—we don’t just say we can do it; we have a proven track record.
- High-quality service and a values-driven company with a focus on customer satisfaction.
Informatics
MedTrials’ Informatics Team integrates a skilled team of professionals into the project development process as early as possible. This approach builds team identity and communication and promotes early collaboration in order to provide high-quality data that is accurate, accessible, and ready for analysis in a cost-effective and timely manner.
Our Informatics Team delivers:
- Customized data management solutions to satisfy client, regulatory, and scientific needs.
- Expertise in database development and data management activities using tools that best meet sponsor requirements.
- Assigned staff trained in therapeutic areas and study-specific assessments.
- Integrated technology solutions—automation and access to information to our study sponsor’s advantage.
QA & Compliance
At MedTrials, quality and compliance are sacrosanct.
At the end of the day our mission is to ensure we detect problems early in order to implement corrective actions quickly and effectively. We leverage decades of professional experience to verify the integrity of data and ensure the proper adherence to protocols.
Our clinical research services include:
- Quality audits
- GAP analyses
- Quality system consulting and SOP development
- Mock inspections
- Audit/inspection readiness
- New/annual vendor (CRO, EDC, Lab) qualification management
- CAPA and root cause analysis support
Training & Professional Development
MedTrials delivers best-in-class, innovative, and impactful training in a variety of modalities—from live presentations to self-paced eLearning and simulations. Beyond just theory, our convenient, dynamic, and engaging presentations and training courses furnish you with a practical, real-world understanding of current issues and trends.
As an approved Continuing Education Provider through the State of Florida Board of Registered Nurses, MedTrials can offer CNE.
Most In-Demand Courses:
- GCP Training
- Annual GCP Update
- Industry Hot Topics
- Inspection Readiness
- Role-Based Training
- Project-Specific Training