Clinical Trial Management
At Pacific Clinical Research, we offer comprehensive clinical trial management services to ensure smooth execution and successful completion of your clinical studies. Our team of seasoned project managers brings a wealth of experience in managing trials across various therapeutic areas and phases of research. We focus on providing personalized service, aligning our strategies with your specific goals and ensuring maximum efficiency and quality in trial execution.
Our clinical trial management services extend beyond the basics. We offer oversight for global contract research organizations, ensuring your trial is held to the highest standards. We understand the critical role a well-structured team plays in determining the outcome of a trial, and we are committed to providing top-notch talent for every project. We support our clients through feasibility studies, budget and timeline management, and project rescue and recovery when needed, ensuring your investment in clinical trials yields the best results.
Clinical Monitoring
Clinical monitoring is an integral part of clinical research, and at Pacific Clinical Research, we prioritize quality over quantity. Our clinical research associates (CRAs) are devoted to a single sponsor or program, allowing for detailed attention to your trial. We understand that each project is unique and customize our monitoring approach to meet your specific objectives.
Our CRAs and project managers partner with you from the start, aiding in site selection and initiation, conducting routine monitoring visits, and wrapping up with meticulous close-out visits. We offer a holistic approach to monitoring, with a focus on data quality and detail that comes from years of maturity and on-site experience.
Medical Writing
Pacific Clinical Research’s medical writing team is committed to delivering clear, concise, and compliant documentation for your clinical trials. Our experts craft precise and effective clinical protocols, ensuring they align with your study objectives and adhere to regulatory guidelines.
Our experience extends to creating comprehensive investigator brochures, providing essential information about your investigational product, and facilitating investigator understanding and compliance. Additionally, our medical writers are skilled in preparing robust Clinical Study Reports, providing a thorough and accurate representation of your study to support your regulatory submissions and future research.
Pharmacovigilance & Drug Safety
Patient safety is our top priority at Pacific Clinical Research. Our dedicated team ensures robust safety reporting and analysis, documenting and investigating all safety-related events to provide data that supports decision-making and regulatory compliance. We offer comprehensive risk management strategies, monitoring and mitigating potential risks associated with your investigational product.
In addition to our active vigilance during the trial, we also offer post-marketing surveillance services to monitor the safety and effectiveness of your product in the broader population. Our team is adept at ensuring your clinical trial’s compliance with global regulatory requirements for pharmacovigilance, ensuring the long-term success and safety of your product.
Trial Master File Management
Pacific Clinical Research provides expert Trial Master File (TMF) management services to ensure your documentation is always audit-ready and compliant. We offer guidance in setting up and maintaining your TMF, conducting regular quality control checks and audits to ensure the integrity of your files.
Our team is well-versed in global regulatory requirements for TMFs, and we ensure your TMF is compliant with these standards. Upon completion of your trial, we manage the archiving of your TMF, ensuring long-term preservation and easy retrieval of your documents. Our efficient systems ensure your trial data is safe and accessible whenever needed.
Quality Assurance
At Pacific Clinical Research, we understand that quality assurance is essential for successful clinical research. We offer expert guidance in establishing robust quality systems and procedures tailored to your trial, conducting stringent quality control checks and audits to maintain high standards.
Our team has deep knowledge of global regulatory standards and ensures your trial’s adherence to all relevant guidelines. In addition to these services, we offer comprehensive training programs to equip your staff with the necessary skills for maintaining quality in your operations. Our team