GVI Clinical Development Solutions (CDS)
GVI Clinical Development Solutions, often referred to as CDS, is an innovative Contract Research Organization (CRO) and an integrated drug development solutions company headquartered in Winnipeg, Manitoba, Canada. The company???s core mission is to accelerate the product development timelines for its clients, thereby maximizing their capital and time by offering a proven, flexible, one-stop solution that reduces the need for multiple service providers.
CDS specializes in providing hands-on clinical and regulatory support tailored to the unique needs of emerging and small to mid-sized life science companies. Their client base primarily consists of pharmaceutical, biotechnology, medical device, diagnostic, and nutraceutical companies, as well as academic or public health institutions carrying out their own clinical trials. The company's expertise is leveraged to help sponsors achieve proof of concept established earlier and bring new products and indications to market faster, often by improving speed and ease from lead candidate selection to clinical proof of concept and beyond. A core advantage is their deep, decades-long knowledge of North American regulatory affairs, specifically with the FDA (U.S.) and Health Canada.
Continue…Core Services and Areas of Expertise
GVI Clinical Development Solutions provides a comprehensive suite of services that cover the entire clinical development lifecycle. These services are often delivered as end-to-end support for a product or as complementary assistance for specific project needs.
Strategic Drug Development and Consulting
CDS acts as a strategic partner, offering consulting services to guide the overall product development pathway.
- Strategic Consulting: Providing expert advice on product development, prioritizing clinical development needs, and designing strategies to achieve project goals.
- Strategic Drug Development: Offering a high-level approach to navigate the complexities of bringing a product from candidate selection through to market.
- Regulatory Affairs Strategy: Utilizing in-depth knowledge of FDA and Health Canada regulations to develop submissions and manage interactions with regulatory agencies.
- Clinical Trial Planning: Assisting with the initial planning phases of a clinical study.
Clinical Trial Management (CTM)
The company offers full-service clinical trial management in both Canada and the U.S., focusing on driving high-quality outcomes on time and within budget.
- Project Management: Providing experienced project managers who serve as the hub of the clinical trial, ensuring seamless integration, proactive communication, and effective leadership to deliver results.
- Clinical Trial Monitoring: Offering monitoring services for clinical studies.
- Protocol Development: Expertise in developing focused and feasible Protocol Synopses and Full Protocols that are readily accepted by Regulatory Agencies, Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), and investigators.
- Investigator Services: Managing Investigator Selection and Contracting, drawing on extensive trial management experience to access the appropriate investigators for timely and budget-conscious delivery of quality data.
- Site Selection and Management: Providing services for selecting suitable clinical sites.
- Clinical Vendor Selection: Helping clients develop and implement a clinical vendor strategy, including vendor assessments and critical factor assessment for successful sponsor-vendor partnerships.
- Resource Needs Planning & Assessments: Assisting clients with simplifying data collection and study monitoring to improve quality and achieve time- and cost-savings.
Regulatory and Quality Assurance
CDS provides extensive support to ensure compliance and quality throughout the development process.
- Regulatory Affairs: Comprehensive support for submissions and management of regulatory processes.
- Quality Assurance (QA): Services include developing, establishing, and maintaining Quality Compliance programs, as well as managing SOPs, complaints, deviations, change controls, vendor quality management, and internal/external auditing. They also offer support for ISO Certification.
- Pharmacovigilance (Drug Safety): Offering drug safety evaluation and post-market pharmacovigilance services.
Data and Scientific Services
The CRO supports the technical and documentation requirements of a clinical program.
- Scientific Writing: Providing expert services for all required documentation.
- Data Management: Handling the data collection and management aspects of the clinical study.
- Biostatistics: Offering biostatistical support for clinical data analysis.
- eClinical Solutions: Through collaborations, GVI CDS offers access to proven web-based eClinical solutions for comprehensive electronic data capture, clinical trial management, and clinical data management functionality.
