Clinical Monitoring
Clinical Monitoring
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Dedicated Team Oversight
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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Site Concierge
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.
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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
Vanguard CRAs utilize Veeva 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.
Clinical Trial Management
Clinical Trial Management
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Dedicated Clinical Trial Team
Vanguard Clinical operates as an extension of each sponsor through agile teams built for efficiency. A single Clinical Operations Manager drives all aspects of study delivery; streamlining oversight from start to finish.
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Full-Service Global CRO Oversight
All Vanguard Clinical Operations Managers possess extensive experience that enables them to effectively oversee CRO trial operations with transparency and expertise.
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Project Rescue & Recovery
At Vanguard Clinical we have 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, flexibility, and compliance.
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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. Thus reflecting our commitment to innovation and patient-centricity, which opens a variety of remote capabilities, 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 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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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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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
Our patient-centric approach to recruitment leverages innovative methods to improve participant experience and retention. Vanguard Clinical collaborates with patient advocacy groups, utilizes social media platforms, and accesses patient registries, including those from VA services, to connect with target populations and build lasting relationships throughout the clinical trial process.
Quality Assurance
Quality Assurance
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Quality Oversight
Vanguard QA enhances Sponsor oversight by providing regulatory expertise and operational transparency, upholding the highest standards in clinical trial conduct.
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Custom SOP and QMS Solutions
Vanguard Clinical partners with Sponsors to develop bespoke Standard Operating Procedures (SOPs) and implement flexible Quality Management Systems (QMS) that support regulatory compliance, operational consistency, and quality across all phases of a trial.
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Comprehensive Auditing and Vendor Qualification
From GxP and site audits to vendor qualification and oversight, Vanguard Clinical ensures that every aspect of your trial ecosystem meets the highest regulatory standards. Our QA team applies a methodical, transparent process to drive compliance and confidence.
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Deviation and CAPA Management
Vanguard Clinical’s QA experts lead root cause investigations and coordinate targeted, sustainable, and realistic corrective and preventative action (CAPA) plan that ensure compliance and continuous improvement.
Regulatory Affairs
Regulatory Affairs
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Regulatory Strategy and Planning
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 the current and 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.
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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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Single Point of Contact
Through Vanguard’s single point of contact approach for Study Start-Up and our expertise in budget and contract negotiations, we help Sponsors achieve faster site activation timelines, resulting in significant cost and time savings.
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Data-Driven Site Identification, Feasibility, and Selection
Vanguard’s SSU database accelerates site and PI identification, optimizing workflows and enabling the selection of high-performing sites. By leveraging historical performance data, we streamline the process, reducing delays and minimizing the risk of costly site failures, ultimately helping Sponsors achieve quicker timelines and lower operational costs.
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Comprehensive Site Budget and Contract Management
Vanguard Clinical manages site budget and contract negotiations with a focus on transparency and fairness. From customized budget templates to skillful negotiation of Clinical Trial Agreements and Confidential Disclosure Agreements, we ensure optimized Sponsor investments and foster strong, collaborative partnerships with sites.
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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Quality-Driven TMF Management
Vanguard Clinical provides tailored TMF solutions, whether operating within Sponsor systems or our Veeva Vault, delivering accurate and complete documentation on schedule. A dedicated TMF Manager oversees the process, giving sponsors confidence in documentation quality, compliance, and visibility across trial milestones.
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End-to-End eTMF System Support
From implementation and onboarding to ongoing administration, Vanguard Clinical delivers full eTMF support by ensuring seamless integration, system reliability, and a user-friendly experience for Sponsors and their teams.
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Tailored TMF Processes & Continuous Quality Monitoring
Vanguard crafts customized TMF processes and templates that streamline documentation and promote inspection readiness. Our governance model, backed by real-time TMF health assessments, ensures transparency, control, and compliance from study start to close.
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TMF Migrations and Remediations
At Vanguard Clinical, we support Sponsors by leading TMF migration and remediation projects with precision to ensure data integrity, regulatory compliance, and minimal disruption to trial timelines.
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 believe a strong therapeutic focus is the foundation of clinical excellence. We offer a depth of knowledge in a broad range of therapeutic areas and the expertise necessary to design, manage, and execute successful clinical trials.
Central Nervous System
Early Phase Oncology
Rare Disease
Cardiology
Dermatology
Endocrinology
Gastrology
Hematology
Immunology
Infectious Disease
Nephrology
Ophthalmology
Orthopedics
Pediatrics
