NexusCRO is a leading full service clinical research organization (CRO) committed to empowering its clients with the knowledge to bring products to the market quickly and easily with proven expertise in supporting global clinical trials for pharmaceutical and biotech companies. We provide clients with customized services from initial strategic planning through regulatory submissions and approval.(Global IQ) NexusCRO’ score competencies are in product agency registration support, trial design, site selection, project management, medical and site monitoring, data management, biostatistical analysis, pharmacovigilance, medical writing, metrics development and full clinical trial management and consulting services. We are dedicated to ensuring that each clinical trial is executed to the highest possible standards. For companies worldwide, Nexus is a trusted partner in clinical research
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CLINICAL OPERATION
Our clinical operations team is highly experienced and trained in effective site management services, ranging from feasibility study to study close-out. Collectively, the team has vast experiences in several therapeutic areas. We ensure the best clinical services, highest ethical standard and quality clinical data.
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PROJECT MANAGEMENT
At NexusCRO we consider our success in the success of our Clients project. We work as a strategic partner to complement your team. We are experienced in the management of clinical studies in all phases I-IV, in all major therapeutic indications.
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SITE MANAGEMENT
A thorough feasibility and site selection is the basis of any successful clinical trial. Our feasibility group has worked on virtually every therapeutic area.Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial.
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PROTOCOL DEVELOPMENT
A well-designed set of Standard Operating Procedures (SOPs) can improve efficiency, lower costs, elevate compliance, clarify team roles, reduce training requirements, raise quality, improve safety, and enhance your ability to troubleshoot and correct problems.
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SITE MONITORING
NexusCRO provides comprehensive site monitoring and management. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with GCP/ICH Guidelines and follows FDA/EMEA regulations.
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REGULATORY AFFAIRS
We support our client's product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies.
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DATA MANAGEMENT
Our primary goal in data management is to provide clean, locked databases, in a suitable format, on time and on budget. Clinical Data Management (CDM) team experts are committed to upholding a standardized, process-driven approach.
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PHARMACOVIGILANCE
NexusCRO offers pharmacovigilance solutions for clinical safety, post-market surveillance and risk management or risk minimization plans. Our Medical Affairs team is comprised of experienced clinical professionals who analyze the safety profile of their products throughout all the phases of clinical development and post-marketing.
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MEDICAL WRITING & TRANSLATIONS
Medical Writers have medical, pharmaceutical and life science backgrounds and are experienced in producing high quality Phase I–IV clinical documentation across a wide range of therapeutic areas that strictly adhere to ICH-GCP guidelines and local regulatory requirements. We understand the importance of communicating the details clearly, concisely, and accurately.
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QUALITY ASSURANCE
Quality Assurance includes all planned and systematic evaluations necessary to ensure that all quality requirements are fulfilled and that a trial is conducted, the data generated, documented (recorded) and reported in compliance with GCP and regulatory requirements.
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BIOANALYTICAL
All assays and methods are validated according to US-FDA guidelines. In addition to providing support for in-house clinical pharmacology activities, our bioanalytical unit also routinely provides support for clinical studies conducted at other sites.