with Comprehensive Services and Capabilities
Clinical Monitoring
Clinical Monitoring
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Dedicated Team Oversight
Through our dedicated Clinical Monitoring department, we employ a selective process for CRA recruitment, providing support for each CRA via direct line management, initial and ongoing training and education, quality oversight from our Clinical Operation Managers, and continued career development, reflecting our commitment to excellence and employee growth.
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Tailored Sponsor Care
Vanguard CRAs are dedicated to one Sponsor, allowing them to focus their efforts on understanding the intricate details of the protocol and disease indication, fostering strong partnerships and ensuring protocol compliance, risk mitigation, and strong site staff relationships at each visit, reflecting our commitment to personalized service and quality.
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Conduct of Visits
Vanguard CRAs conduct pre-study visits, site initiation visits, routine monitoring visits, and close-out visits with GCP/ICH principles in mind and ensuring protocol compliance, risk mitigation, and strong site staff relationships at each visit, reflecting our commitment to excellence and adherence to regulatory standards.
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Risk Mitigation through CTMS
Vanguard CRAs utilize CTMS to provide real time data to the Sponsor relating to milestones, action items, issues, tasks, and enrollment status, allowing the whole study team to determine risks to the success of the study throughout the lifecycle, reflecting our commitment to transparency and efficiency.
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Site Relationship Management
Vanguard CRAs are experts in site management, ensuring that issues at sites are addressed promptly and thoroughly, allowing sites to work efficiently and accelerate data quality, reflecting our commitment to partnership and excellence in clinical trial execution.
Clinical Trial Management
Clinical Trial Management
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Full-Service Project/Trial Management
Drawing from the collective experience of the Vanguard team, Vanguard Clinical offers cradle-to-grave clinical trial management across all phases of research and diverse therapeutic areas, guided by our commitment to innovation and integrity.
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Full-Service Global CRO Oversight
All Vanguard Clinical Operations Managers possess extensive experience working at both Sponsor and CRO companies, enabling them to effectively oversee CRO trial operations with transparency and expertise.
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Project Rescue & Recovery
Difficulties may arise when a study does not proceed as anticipated, and Vanguard Clinical has a proven track record of recovering studies from global CROs and setting them back on the path to successful completion, guided by our dedication to excellence and flexibility.
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Decentralized Clinical Trial (DCT) Management
Our clinical trial management approach is versatile and includes the ability to execute traditional site-based trials, hybrid trials, and a fully decentralized model, reflecting our commitment to innovation and patient-centricity, which opens a variety of remote capabilities/flexibilities, improves patient retention, and strengthens recruitment initiatives for rare disease indications.
Data Management & Biometrics
Data Management & Biometrics
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Full Service Clinical Data Management
End-to-end support for Clinical Data Management System (CDMS) set-up, integrations, data cleaning and reporting, vendor management, and database lock across a wide variety of therapeutic areas, with a commitment to transparency and excellence.
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Full Service Medical Coding
Offering development and management of Coding Plans. Coding services range from manual coding options to CDMS setup and implementation of medical coding, utilizing standardized medical coding dictionaries, including but are not limited to MedDRA, WHODrug, WHODrug ATC 5 and COSTART ensuring consistency and accuracy of coding.
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Full-Service Data Entry
Providing Clinical Study Coordinator (CSC) data entry services for sites with rapid enrollment and/or sites requiring additional resources. The focus of our CSCs is data accuracy, assisting with query resolution, optimizing the safety of research subjects by assisting with Adverse Event reporting and much more. The CSC work ethic and outputs reflect our commitment to efficiency and integrity.
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Biostatistical Services
Supporting all statistical needs with the implementation of statistical methodology for clinical plans and protocol development, Randomization Schemes, PK analysis Plans, Table Figure and Listings (TFLs), CDISC, ADaM and much more. Our Biometrics team focuses on providing sound scientific principles to guide every aspect of our operations.
Medical Writing
Medical Writing
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Regulatory Document Preparation
Vanguard Clinical provides comprehensive support in preparing regulatory documents, including Investigator Brochures, Clinical Study Reports, and Regulatory Submissions. Our experienced medical writers ensure accuracy, clarity, and compliance with regulatory requirements, facilitating efficient review and approval processes.
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Scientific Communication and Publication Support
We offer expert assistance in manuscript preparation, abstracts, posters, and presentations for scientific conferences and peer-reviewed journals. Vanguard Clinical collaborates closely with clients and key opinion leaders to communicate study findings and advance scientific knowledge in relevant therapeutic areas.
Patient Recruitment
Patient Recruitment
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Strategic Patient Recruitment Planning
Vanguard Clinical develops tailored recruitment strategies based on thorough market analysis, patient demographics, and therapeutic area considerations. Our proactive approach includes digital marketing campaigns, community outreach initiatives, and patient engagement programs to optimize enrollment timelines and retention rates.
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Scientific Communication and Publication Support
We prioritize patient-centricity in recruitment efforts, employing innovative methods to enhance participant experiences and retention. Vanguard Clinical leverages patient advocacy groups, social media platforms, and patient registries to connect with target populations and foster meaningful relationships throughout the clinical trial journey.
Quality Assurance
Quality Assurance
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SOP Development & Document Control
Specializes in crafting and customizing Standard Operating Procedures (SOPs) and associated documents tailored to all aspects of clinical trial management engaged by Sponsors.
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Training Program Development
Our Quality Assurance Team, driven by passion and guided by our mission, has curated a robust training program encompassing all facets of Quality management and clinical trial operations.
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Audits – GCP, Site, and Internal Audits
With extensive experience in conducting qualification and for-cause audits of investigator sites and vendors, Vanguard Quality Assurance supports Sponsors in meeting their qualification needs while maintaining co-active communication.
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Deviation and CAPA Management
Vanguard’s Quality Assurance team will perform root cause analyses and assign appropriate corrective or preventative actions that are feasible to all involved parties.
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Vendor Management Qualifications and Audits
Through a robust process including the assessment of vendor capabilities and validations, Vanguard’s QA Team is able to provide vendor management expertise that efficiently and effectively qualifies vendors.
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Quality Oversight
Leveraging our unwavering integrity and expertise in regulatory requirements, Vanguard QA provides additional oversight of the clinical trial management process, ensuring transparency and adherence to the highest standards.
Regulatory Affairs
Regulatory Affairs
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Regulatory Strategy and Planning
Vanguard Clinical offers strategic guidance in navigating regulatory pathways and requirements for clinical trial approval. We develop customized regulatory strategies aligned with client objectives and regulatory guidelines to ensure timely approvals and compliance. Vanguard Clinical empowers clients and stakeholders with the knowledge and skills needed to mitigate and avoid potential risks to timelines based on current/changing regulatory landscapes.
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Regulatory Submissions Management
Our experienced team manages the preparation, compilation, and submission of regulatory documents to health authorities, including Investigational New Drug (IND) applications, Investigational Device Exemptions (IDEs), and Marketing Authorization Applications (MAAs).
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Labeling and Packaging Compliance
We provide expertise in labeling and packaging compliance, including product labeling design, review, and approval to meet regulatory requirements. Our meticulous approach ensures accuracy, consistency, and compliance with labeling regulations across target markets.
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Post-Market Regulatory Support
Vanguard Clinical offers comprehensive support for post-market regulatory activities, including adverse event reporting, periodic safety updates, and regulatory compliance monitoring. We help clients navigate post-market requirements and maintain product compliance throughout the product lifecycle.
Site Payments and Contracts
Site Payments and Contracts
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Contract Negotiation and Management
Vanguard Clinical specializes in negotiating and managing contracts with clinical trial sites, vendors, and partners on behalf of our clients. We ensure favorable terms and conditions while maintaining transparency and integrity throughout the process.
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Budget Development and Financial Management
Our team crafts comprehensive budgets tailored to each clinical trial, considering all relevant expenses and contingencies. We provide diligent financial management throughout the trial lifecycle, ensuring adherence to budgetary constraints and timely payments.
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Payment Processing and Compliance
Vanguard Clinical manages all aspects of payment processing, including invoice review, approval, and disbursement to sites, vendors, and stakeholders. Our rigorous compliance protocols ensure adherence to regulatory guidelines and industry best practices.
Study Start-up
Study Start-up
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Study Start-Up Oversight, Workflow Management, and Document Collection
Tailored solutions for workflow management and document collection, demonstrating our commitment to efficiency and excellence from the outset.
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Site Identification/Feasibility
Utilizing multiple sources for evidence-based site and investigator identification, Vanguard Clinical ensures optimal site selection and robust partnership.
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Site Budget Development
Customized budget templates aligned with fair market value (FMV) benchmarks, illustrating our commitment to optimizing sponsor investments, with a focus on transparency and fairness in financial management.
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Site Budget Negotiations
Efficiently negotiating budget solutions agreeable to all involved parties, Vanguard Clinical fosters seamless negotiations and strong partnerships with our clients and sites, to foster collaborative success at every step.
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Site Contract Negotiations
Skillful and principled negotiation of Clinical Trial Agreements, Confidential Disclosure Agreements, and related contracts, embodying our commitment to integrity in all business interactions.
Training & Education
Training & Education
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Clinical Trial Personnel Training
Vanguard Clinical offers customized training programs for clinical trial personnel, including investigators, site staff, and study coordinators. Our interactive workshops and educational materials cover protocol-specific requirements, regulatory compliance, and best practices in clinical research.
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Continuing Education and Professional Development
We provide ongoing educational resources and opportunities for clinical research professionals to stay abreast of industry trends, regulatory updates, and technological advancements. Vanguard Clinical fosters a culture of continuous learning and professional growth among our clients and partners.
Trial Master File Management
Trial Master File Management
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End-to-End TMF Management
Complete end-to-end eTMF management within sponsor-owned eTMF systems or Vanguard Clinicals’ in-house eTMF system, Veeva Vault, reflecting our commitment to efficiency and innovation.
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eTMF Implementation
Leading implementation projects for sponsor-owned eTMF systems, Vanguard Clinical ensures seamless integration and training, driven by our dedication to excellence.
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eTMF System Administration
Offering ongoing eTMF system administration support, Vanguard Clinical ensures smooth operations and user satisfaction, guided by our commitment to co-active communication.
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Process Development
Expertly crafted process development and optimization, including TMF Plan and Index templates, reflect our dedication to enhancing inspection readiness and overall trial efficiency.
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TMF Migrations and Remediations
Providing full support from planning to execution for TMF migration and remediation endeavors, Vanguard Clinical ensures seamless transitions and compliance with the highest standards.
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Governance and Quality Assessments
Establishing robust TMF Health metrics and governance structures, Vanguard Clinical provides real-time insights into study TMF health, ensuring inspection readiness and integrity in every aspect of our operations.
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Dedicated TMF Manager
Vanguard has a single point of contact for the client’s TMF projects to ensure quality, complete, and timely clinical trial documentation.
Vendor Management
Vendor Management
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Clinical Operations
Our trial management expertise extends to efficiently and effectively managing and overseeing study vendors, including central laboratories, imaging & radiology laboratories, cardiac safety data collection, data management and EDC CROs, safety and pharmacovigilance, and site management organizations, reflecting our commitment to quality and partnership.
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Data Management
Comprehensive oversight of data management CROs, reflecting our dedication to quality and partnership with our clients.
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Quality Assurance
Experts in Vendor Management, Vanguard QA assists sponsors in selecting, auditing, and managing vendors suitable for their unique clinical trials, driven by our commitment to transparency and integrity.
At Vanguard Clinical, we know that therapeutic focus is necessary for clinical excellence. As a full-service CRO, we offer a depth of knowledge in select therapeutic areas and the expertise necessary to design and manage successful clinical trials.
Cardiology
Nephrology/Dialysis
Pediatrics
Dermatology
Neurology
Rare Disease/Orphan Drugs
Endocrinology
Oncology
Vascular Disease
Gastrology
Ophthalmology
Virology
Immunology
Orthopedics
Wound Healing
