Drug Safety and Pharmacovigilance
Our drug safety teams are strategically located in different time zones across the United States, Europe and Asia/Pacific to ensure uninterrupted service. We provide global drug safety expertise in all phases of clinical research for Serious Adverse Event/Adverse Event (SAE/AE) collection, evaluation, classification, reporting, and reconciliation. We use either our own or our customer’s drug safety database for timely reporting to regulatory authorities, including electronic European reporting. In addition, to meet stringent timelines for regulatory compliance and SAE follow-up, we provide a 24/7 drug safety hotline.
Medical Monitoring
Our in-house physicians provide round-the-clock medical monitoring services, as well as scientific and medical support for project management teams and investigative sites. Our team consists of seasoned clinicians and clinical researchers who combine many years of patient-care experience with their trial-management expertise. They have a diversity of backgrounds and specialties and cover the range from small proof-of-concept studies to large multinational pivotal studies with equal flexibility. Our highly experienced team enables seamless coverage for studies.
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Patient Recruitment and Retention
We are committed to ensuring the success of your trial. Our Patient Recruitment Services Group can serve as an integral part of your trial team and identify and manage the most appropriate vendors for your needs. We can develop the best patient recruitment and retention strategies to help you meet key milestones for your program and serve as a liaison to a number of media outlets and other INC Research validated vendors.
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Project Management
We maintain a project centric focus across the organization in support of high performance teams with our Trusted Process. From PlanActivation® to our QualityFinish®, our exceptional teams lead our QuickStart® implementation process for each study, to ensure we aggressively and proactively plan for and execute on critical milestones within agreed upon timelines. Our project teams include key managers from all appropriate functional areas within the organization, each with related therapeutic expertise and firsthand industry experience.
The project lead ensures our customers are provided a notably high quality of service throughout the life of their study. Solid project management skills – ongoing communication with external and internal project teams, proactive management techniques, and therapeutic expertise that secures study success – are the cornerstone of our Trusted Process approach. These skills are provided by project management teams who clearly understand the factors critical to clinical trials.
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Quality Assurance
Quality control steps are built into all of our processes. We have an independent quality assurance department that engages ongoing quality and compliance assessments of all of the services we offer. In particular, we regularly conduct internal process audits to ensure compliance with good clinical practices, standard operating procedures, vendor qualifications, and commitments to clients – all for the purpose of continuously insuring the quality of our services remains at the highest level.
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Regulatory and Medical Writing
We offer regulatory and medical writing expertise across the entire product lifecycle. Whether providing operational support or strategic consultancy, our goal is to maximize clients’ potential for success. We understand the importance of time and the value of flawless execution. Our Regulatory Affairs and Medical Writing team has a global footprint with subject matter experts located in our offices throughout the world to ensure we maintain a global regulatory umbrella for our clients (e.g., EU countries, Eastern Europe, Australia, India, Mexico). Our team has substantial hands-on regulatory and medical writing knowledge gained through successful and diversified experience in large pharma, emerging biotech, CROs, and FDA.
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Study Monitoring
Our CRAs bring strong monitoring and clinical experience to our customers with most of their experience in our key therapeutic and specialty areas. In addition, each member is fully trained in FDA regulations, ICH guidelines, and GCP/SOP compliance. As a result, our regionally based monitors worldwide thoroughly understand the many complexities associated with trials in the therapeutic area in which they primarily practice, in the region within which they work and accordingly, provide quality and performance feedback, study training and technical support, data query resolution, source document review, and site management for all types of visits.
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For more information on INC Research’s Trial Services capabilities, click here. |
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